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Australian Clinical Trials

Search results from the Australian New Zealand Clinical Trials Registry

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Keyword: cannabidiol
Recruitment Status: Recruiting

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The Effects of Cannabidiol (CBD) on Affective and Physiological Responses to Exercise in Healthy Endurance-Trained Runners

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Trial Information

Trial summary

This study is a randomised, double-blind, placebo-controlled, dose-ranging crossover study, investigating the effects of purified, oral cannabidiol (CBD) on affective and physiological responses to aerobic exercise in healthy trained individuals. Participants will attend the study site on four occasions to complete an initial eligibility screen and three treatment sessions. Each treatment session will involve a controlled bout of submaximal exercise (i.e., 60 minutes of running at a fixed, moderate intensity, ~70% VO2max), a short (30 minute) recovery and an incremental run to volitional exhaustion. Individuals will receive placebo or an acute dose of CBD (50mg or 300 mg) 1.5-hours prior to the onset of exercise on each occasion. We hypothesise that CBD will improve overall exercise tolerance; that is, it will increase affective valence, decrease relative VO2 (i.e., % VO2max) during submaximal exercise and increase time to exhaustion (TTE).

Broad Health ConditionMetabolic Disorders

Specific Health ConditionMetabolic and Endocrine
Metabolic disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment25/07/2022

Anticipated date of last participant enrolment25/05/2023

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

(a)	Healthy individuals aged between 18–45 years
(b)	Endurance-trained runners, i.e., who have run an average of more than (or equal to) 40 km·wk-1 for the last month (or more) and can sustain moderate intensity running exercise for >60-minutes    
(c)    The use of hormonal contraception for more than (or equal to) 3 months (for females)
(d)	No reported use of cannabis or cannabinoids within the past 3 months; to be confirmed by a negative urine drug screen (UDS) at the medical screening; and
(e)	Proficient in English and able to provide informed consent

Minimum age18 Years

Maximum age45 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

(a)	Cannabis dependence or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision (ICD)-10 criteria or at a medical doctor’s discretion;
(b)	A history (self-reported) of allergic reaction (e.g. rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabis, cannabis products or cannabinoids;
(c)	A history (self-reported) of a clinically significant adverse response to cannabidiol (CBD); 
(d)	A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion, except, mild to moderate depression (score <20 on the Beck Depression Inventory [BDI]) or mild to moderate anxiety (score <16 on the Beck Anxiety Inventory [BAI]); 
(e)	A history of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire (PHQ)-9;
(f)	A (self-reported) history of, or current, cardiovascular, respiratory, renal, neurological, gastrointestinal, or endocrinological disorders;
(g)	Pregnant or lactating. All female volunteers of child-bearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening and prior to each treatment session. All females of child-bearing potential and males with female partners must agree to use a reliable form of contraception during and one month following their participation in this project       
(h)	A major illness or injury that interrupted their usual training routine for a period of more than (or equal to) 3 weeks during the past 3 months; 
(i)	Inability to refrain from using anti-inflammatory medications (4 days) prior to each treatment session;
(j)	Inability to refrain from consuming alcohol (24 h) and caffeine (12 h) prior to each treatment session;
(k)	Inability to refrain from using cannabis, cannabinoids and illicit drugs while participating in this project; 
(l)	 Use of medications that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system);
(m)	Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta blockers, sulfonylureas and anti-convulsants; and
(n)	Required to complete mandatory drug testing for cannabis (e.g., workplace testing)
(o)	 Competing in a World Anti-Doping Agency (WADA) sanctioned sporting event (within 3 months).
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Sydney
Primary Sponsor Address: Camperdown, NSW, 2006 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12622000717752

UTNU1111-1273-5212

Contact person for information and recruitmentMs
Ayshe Sahinovic
University of Sydney, Room 611, Brain and Mind Centre, 94 Mallet Street, Camperdown NSW 2050
+61 449 786 042

Further information iconayshe.sahinovic@sydney.edu.au
Australia

Effects of cannabidiol (CBD) on chronic pain following spinal cord injury

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Trial Information

Trial summary

Background:
Approximately half of all spinal cord injury patients develop chronic pain. Current treatments for this pain have proven to be largely ineffective and many have significant side-effects. We will examine whether a novel non-intoxicating component of cannabis, cannabidiol (CBD), can reduce pain. Using modern brain imaging techniques, we aim to determine if pain reductions result from normalisation of brain, immune, psychological and sleep function. In addition, we aim to identify a biomarker that will predict whether an individual will respond to CBD treatment, easing suffering, saving time and reducing costs. 

Study Aim:
To determine the impact of CBD treatment on chronic pain following SCI and to investigate biological changes associated with reduced pain.

Hypothesis:
We hypothesise that CBD treatment will reduce ongoing pain to a significantly greater degree than placebo. Furthermore, we hypothesize that pain relief during CBD treatment will be associated with reduced diffusivity markers of astrogliosis, reduced resting infra-slow oscillations in the ascending pain pathway, restored thalamic blood flow to control levels and reduced thalamocortical rhythm power. We also hypothesize that CBD treatment will reduce ongoing peripheral inflammatory markers, improve sleep and psychological state and that this will correlate with a reduction in ongoing pain. Finally, we hypothesize that pain relief during CBD treatment will be associated with pre-trial levels of endogenous pain modulatory ability and endocannabinoid levels.

Broad Health ConditionChronic pain
Spinal cord injury

Specific Health ConditionInjuries and Accidents
Other injuries and accidents
Anaesthesiology
Pain management

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Postcode
2050 - Camperdown

Postcode
2031 - Randwick

Anticipated date of first participant enrolment1/05/2023

Anticipated date of last participant enrolment1/05/2024

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

(a)	Complete or incomplete spinal cord injury as determined using the ASIA scale;
(b)	Below-level neuropathic pain for minimum 3 months duration;
(c)	Adult (18 years and over) who is able to provide informed consent; and
(d)	Proficient in English (must not require an English translator)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

(a) Spinal cord injury in acute stage of recovery (<12 months post-acute spinal cord injury or at the medical doctor’s discretion); 
(b) If on pain relieving medications must be on stable dose for at least 6 weeks prior to beginning our trial. This includes all prescription medications for pain including opioids or adjuvant pain medications such as Pregabalin, Amitriptyline and SSRIs. Paracetamol and over-the-counter NSAIDs (e.g., ibuprofen, aspirin, naproxen) within the recommended adult dosage permitted as needed. If there has been recent dose titration then we would wait for a stable 6-week period before entering the individual into the trial.
(c) If on pain relieving medications, they must not be changed in dosage during the trial period;  
(d) Cannabis or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision (ICD)-10 criteria or at a medical doctor’s discretion;
(e) Reported use of cannabis within the past 3 months (or at the medical officer’s discretion);
(f) Urine drug test positive for drugs (cannabis – THC only, meth/amphetamines, and cocaine) at each visit;
(g) A history of (self-reported) allergic reaction (e.g. rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabis, cannabis products or cannabinoids;
(h) A history of (self-reported) a clinically significant adverse response to CBD;
(i) A history of moderate-to-severe hepatic impairment as determined by the medical doctor; 
(j) Use of medication(s) that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system) as determined by the medical doctor;
(k) Unable to undergo MRI brain imaging as identified via 'NeuRA MRI Safety Screening Questionnaire';
(l) A history of a major psychiatric disorder within the previous 12 months except for clinically managed mild anxiety and/or depression as determined via clinical interview using the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion;
(m) Current suicide ideation as determined via clinical interview with the medical doctor;
(n) Pregnancy or lactation - women shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed where necessary;
(o) Patients with quadriplegia secondary to cervical spine injury.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Sydney
Primary Sponsor Address: The University of Sydney Camperdown NSW 2006
Primary Sponsor Country: Australia

Trial IDACTRN12622000634774

UTNU1111-1277-2048

Contact person for information and recruitmentMiss
Anastasia Suraev
University of Sydney. M02F, Level 6, Brain and Mind Centre, University of Sydney, 94 Mallett Street, Camperdown, NSW, 2050
+61439804551

Further information iconanastasia.suraev@sydney.edu.au
Australia

Effects of cannabidiol in children with autism

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Trial Information

Trial summary

Autism spectrum disorder (ASD) is a highly prevalent neurodevelopmental disorder with no validated biomedical treatments for the core social and behavioural symptoms. The current study is a randomised crossover trial to assess whether cannabidiol (CBD) can promote behavioural and neurophysiological improvements in 5- to 12-year-old children. 

Several recent studies have investigated acute CBD administration on neurophysiological processes in the adult autistic brain (Pretzsch, Freyberg, Voinescu, et al., 2019a; Pretzsch, Voinescu, Lythgoe, et al., 2019a, 2019b; Pretzsch et al., 2021a). Others have documented behavioural outcomes following chronic (long-term) administration of the compound (Aran et al., 2019, 2021; Bar-Lev Schleider et al., 2019). To date, no investigation has explored effects of long-term CBD administration on glutamate and GABA concentrations alongside social communication outcomes. With a specific focus on the Research Domain Criteria (RDoC) ‘social processes’ domain (Cuthbert & Insel, 2013), which is heavily implicated in ASD, this study will utilise electroencephalography (EEG) to measure neurophysiological changes after chronic administration of CBD over a 12-week period. EEG will be used to acquire resting-state, social task-related processing, and mismatch negativity (MMN) data. MMN is a recognised measure of glutamatergic NMDA receptor function, and thus, neuronal excitation (Kompus et al., 2015).  

The study is designed to address the following aims: 

Behavioural: to measure the effect of CBD on the RDoC social processes domain in children with autism. More specifically, to observe a change in Social Responsiveness Scale (SRS) scores from baseline to Week 12. 

Neurophysiological: to observe whether CBD ‘shifts’ cortical excitation/inhibition during a social task, measured using EEG. 

Broad Health ConditionAutism Spectrum Disorder

Specific Health ConditionMental Health
Autistic spectrum disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment21/10/2022

Anticipated date of last participant enrolment30/03/2023

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Male or female children aged between and including 5 to 12.  

2. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by The Autism Diagnostic Observation Schedule 2nd edition (ADOS-2). Children with autism will be identified in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V; APA, 2013) criteria. 

3. Stable pharmacologic, educational, behavioural, and/or dietary interventions for 4 weeks prior to randomisation and for the duration of the study;  

4. Presence of a parent/guardian who can provide consent for the participation of their child and complete assessments regarding the child's development and behaviour throughout the study; 

5. Normal/corrected to normal hearing and vision. 

6. IQ of 40 or higher. 

Minimum age5 Years

Maximum age12 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Exposure to any investigational agent in the 30 days prior to randomization;  

2. Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment;  

3. Diagnosis of a known genetic disorder (e.g., Prader-Willi Syndrome, Angelman Syndrome, Tuberous Sclerosis);  

4. A known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or marked sensory impairment such as deafness or blindness;  

5. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, Post-Traumatic Stress Disorder (PTSD) or Major Depressive Disorder (MDD). These patients will be excluded due to potential confounding results;  

6. A medical condition that severely impacts the participant’s ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results, or endangers the participant’s well-being;  

7. Changes in allied health therapies, behavioural, or educational interventions within 4 weeks prior to randomisation other than those associated with school holidays;  

8. Changes in medications or medication doses within four weeks of randomisation.  

9. Contraindications to CBD100: hypersensitivity to cannabinoids, liver, kidney or cardiovascular disease, hypersensitivity to the excipient (MCT) or coconut allergy  

10. Currently taking benzodiazepines, antiepileptic medications (e.g., sodium valproate, clobazam), and barbiturates.  

11. IQ below 40 or severe intellectual disability.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Deakin University
Primary Sponsor Address: 221 Burwood Hwy, Burwood VIC 3125
Primary Sponsor Country: Australia

Trial IDACTRN12622000437763

Contact person for information and recruitmentMs
Nina Parrella
Cognitive Neuroscience Unit (CNU), School of Psychology, Deakin University 221 Burwood Hwy, Burwood VIC 3125
+61 03 92468730

Further information iconparrellan@deakin.edu.au
Australia

A Phase I Clinical Trial of IHL-675A to Assess Safety and Pharmacokinetics in Healthy Volunteers

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Trial Information

Trial summary

This is a phase I clinical trial designed to assess the pharmacokinetics and safety and tolerability of IHL-675A compared to the reference listed drugs Epidiolex (CBD) and Plaquenil (HCQ). The trial will recruit at least 36 healthy subjects.  Initially, 3 sentinels will be enrolled and randomised into Treatment 1, 2, and 3.  Treatment 1 - Two IHL-675A softgel capsules (75mg CBD, 100 mg hydroxychloroquine sulfate per capsule, 150 mg CBD, 200 mg hydroxychloroquine sulfate total). Treatment 2: One 200mg hydroxychloroquine sulfate tablet (Plaquenil), Treatment 3: 1.5mL of 100 mg/mL (150 mg) CBD (Epidiolex)
The sentinels will be dosed at least 24 hours prior to the remainder of the subjects. If there are serious adverse events associated with the dose the trial will be paused and the risk of further subjects receiving IHL-675A will be assessed.
Each Treatment group will enrol at least 12 subjects each, for a total of at least 36 subjects. Subjects will be randomised into the treatment groups. 

The healthy subjects will be informed of the study and pre-screened. Screening will include blood and urine tests, screening for mental and cardiac health using a series of mental health questionnaires and 12-lead ECG in triplicate, respectively. 
Post screening, subjects will be admitted to the clinical unit, where they will undergo baseline assessments, including safety bloods and urine sampling to screen for pregnancy and drugs of abuse.  On Day 1, subjects will be given a high-fat/high-calorie meal 30 minutes prior to dosing. At least 30 min before the time of dosing, the 24-hour telemetry period for cardiac monitoring will commence.   Blood samples for plasma pharmacokinetic analysis, will be taken throughout the study. These samples will be assessed for the Active Pharmaceutical Ingredients as well as metabolites 7-OH-CBD and 7-COOH-CBD, and desethylhydroxychloroquine, desethylchloroquine, and bisdesethylhydroxychloroquine. Blood samples will also be taken for safety analysis.
Subjects are discharged from the clinical unit on Day 2, at least 24 hours post dose, and will return to the clinical unit for outpatient visits on Days 3, 7, 14, 21, and 28 for blood sampling and/or to assess any existing or new Adverse Events, and concomitant medications.
Subjects who have completed Cohort 1 and who continue to meet study entry criteria may be permitted to screen for participation in Cohort 3. 

Broad Health ConditionInflammation

Specific Health ConditionInflammatory and Immune System
Other inflammatory or immune system disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
CMAX Clinical Research Pty Ltd - Adelaide

Postcode
5000 - Adelaide

Anticipated date of first participant enrolment1/08/2022

Anticipated date of last participant enrolment31/10/2022

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Healthy volunteers will be included in the study if they satisfy all the following criteria: 

1.	Ages 18 to 65

2.	BMI 18 to 32

3.	QTcF <450 msec (males), <470 msec (females) at screening

4.	No known allergic reaction to cannabis products with previous use

5.	No known allergic reaction to sesame oil (Epidiolex is formulated in sesame oil)

6.	Have no history of past substance abuse or current abuse of illicit drugs as defined by 
 a negative DOA test at screening

7.	Physically well, in the opinion of the investigator, with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, bleeding, thyroid, cholesterol, or hypertension disorders

8.	If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from 14 days prior to Visit Day 1 through to the end of the study. Subjects must agree to continue to use two approved methods of contraception including the use of a condom for 90 days following the administration of the study drug, and not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
a.	Approved methods of contraception;
i.	Inter-uterine device (IUD) in place for at least 3 months prior to Visit Day 1 through 30 days following the final dosing of the study drug
ii.	Barrier method (condom or diaphragm) for at least 14 days prior to Visit Day 1 through to 90 days following the last administration of the study drug.
iii.	Stable hormonal contraceptive for at least 3 months prior to Visit  Day 1 and barrier method (condom or diaphragm) for at least 14 days prior to Visit Day 1 through to 90 days following the last administration of the study drug.
iv.	Surgical sterilization (vasectomy) at least 6 months prior to Visit Day 1.

9.	Females of non-childbearing potential who have established serum FSH levels >40mlU/ml (determined during screening) are either postmenopausal or have undergone one of the following sterilization procedures at least 6 months prior to Visit Day 1;
a.	Bilateral tubal ligation
b.	Hysterectomy
c.	Hysterectomy with unilateral or bilateral oophorectomy
d.	Bilateral oophorectomy

10.	Females of childbearing potential that are not currently pregnant, lactating, or planning to be pregnant and agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from 14 days prior to Visit Day 1 through to the end of the study. Subjects must agree to continue to use two approved methods of contraception for 30 days following the administration of the study drug. In the event that the sexual partner is surgically sterile, contraception is not necessary.
a.	Approved methods of contraception to use in conjunction with a condom;
i.	 Inter-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug
ii.	Barrier method (condom or diaphragm) for at least 14 days prior to Day 1 through to 30 days following the last administration of the study drug.
iii.	Stable hormonal contraceptive for at least 3 months prior to Visit Day 1 and barrier method (condom or diaphragm) for at least 14 days prior to Visit Day 1 through to 30 days following the last administration of the study drug.
iv.	Surgical sterilization (vasectomy) at least 6 months prior to Visit Day 1.

11.	Not taking any vitamins, herbal remedies, or supplements within 14 days of admission

12.	Able to avoid strenuous exercise from 72 hours prior to admission through to the end of the confinement period (Visit Day 2), and 72 hours prior to Visit Day 7 until the Day 7 outpatient visit is complete

13.	Agrees to eat a full fat breakfast within 30 minutes of administration of the IP 

14.	Voluntarily consent to participate in the study and complete all study required tasks, as instructed by the protocol, including the completion of questionnaires

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening, or prior to dosing at the timepoints in the Schedule of Events
1.	Family history of QT issues

2.	History of significant psychiatric illness (defined as hospitalisation), suicidal ideation, or suicidal attempts

3.	History of alcohol abuse or excessive alcohol intake

4.	Positive urine drug test at screening

5.	Positive alcohol breath test at screening

6.	GAD-7 score of 15 or greater, MDI score 31 or greater OR 3 core symptoms and 5 accompanying symptoms, C-SSRS score of 4 or greater, OR reported suicidal behaviour within the past 3 months

7.	Any dietary requirements incompatible with study breakfast; must be able to eat high-fat, high-calorie diet

8.	In the opinion of the investigator other serious medical conditions 

9.	Hepatic or renal impairment or disease. Defined as AST/ALT greater than 1.5 x ULN, eGFR less than 60 at screening.

10.	Subject has a history of cardiac disease or arrythmias

11.	History of gastrointestinal disorders which may impact absorption, distribution, metabolism and/or excretion of the IP (such as cholecystitis, cholecystectomy, Gilbert’s syndrome)

12.	Inability to adhere to medication restrictions during the study period

13.	Participation in another clinical trial of an investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to study drug administration.

14.	Inability to adhere to the protocol

15.	Any other reason in the opinion of the investigator
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Incannex Healthcare Ltd
Primary Sponsor Address: Unit 207, 11 Solent Circuit Norwest, 2153 New South Wales Australia
Primary Sponsor Country: Australia

Trial IDACTRN12622000289718

Contact person for information and recruitmentDr
Jonathan Newchurch
CMAX Clinical Research Level 5, 18a North Terrace Adelaide 5000 South Australia
+61 8 7088 7900
+61 8 7088 7999
Further information iconcmax@cmax.com.au
Australia

Cannabidiol: Treatment for brain changes and depression in early-stage dementia

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Trial Information

Trial summary

The study aims to investigate the potential therapeutic benefits of cannabidiol (CBD) as a treatment for brain changes and depression in individuals living with early-stage dementia. Accumulating evidence suggests that CBD is a novel, well tolerated medicine with beneficial neurorepair, hormone and symptom regulating effects and it may therefore be a promising candidate to address multiple facets of dementia. However, no trial to date has investigated the effects of pure CBD in people with early-stage dementia. The trial design includes 60 participants randomised to one of two treatment arms (30 CBD, 30 placebo), who will take a daily 300mg dose of their respective capsules for 12 weeks. A comprehensive range of outcome measures will be assessed at baseline, mid- point and post-treatment. It is anticipated that treatment with CBD will lead to improvements in neural structure, cognitive function, psychological symptoms and hormone profiles.

Broad Health ConditionEarly-stage dementia

Specific Health ConditionNeurological
Dementias

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Wollongong Hospital - Wollongong

Postcode
2500 - Wollongong

Anticipated date of first participant enrolment1/06/2022

Anticipated date of last participant enrolment9/01/2023

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Community-dwelling individuals who can provide written informed consent, with a clinician confirmed primary diagnosis of early dementia made within the past 24 months. Participants must have a nominated supporting person, preferably living with them (e.g. spouse) who can assist with daily medication monitoring.
2.	A Stage 3-5 rating on the Global Deterioration Scale (GDS) 
3.	A score of 20-26 on the Mini Mental State Exam (MMSE);
4.	If taking general medications (e.g. Micardis, Advil), participants must have been taking them for a minimum of 6-12 weeks prior to the start of the trial, with no changes to medication regime during the 12-week trial period unless clinician-recommended changes are required for appropriate care.

Minimum age55 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants will be excluded on the basis of:	
1.	MRI contraindications, such as severe head injury, pace devices, coronary or peripheral artery stents, cochlear implants, renal insufficiency or claustrophobia;
2.	Allergies to the excipient used in the formulation of the capsules;
3.	Impaired liver or kidney or heart function;
4.	Active suicidal ideation;
5.	Intake of CBD, THC or cannabis within one month prior to participation;
6.	Prior extensive use of CBD, defined as use greater than weekly for more than 3 months in the two years prior to participation;
7.	A clinically relevant history of recreational cannabis use or other drugs of abuse, defined as more than three times a week for any continuous period of longer than 6 months in duration in the year prior to participation;
8.	Prior history of treatment for alcohol use disorder in the year prior to participation, or a current score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT);
9.	Any current or recent diagnoses of neurological disorders other than dementia, including epilepsy or Parkinson’s disease;
10.	Current use of medications that have clinically relevant interactions with the cytochrome P450 (CYP) 2C19 or CYP3A classes of liver enzymes prior to study inclusion (e.g. antipsychotics, antidepressants, anxiolytics);
11.	Participation in any other clinical drug trials within 30 days of the current study;
12.	Anticipated surgical needs within 3 months of participation.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Wollongong
Primary Sponsor Address: Northfields Avenue, Wollongong, NSW, 2500
Primary Sponsor Country: Australia

Trial IDACTRN12621001364864

Contact person for information and recruitmentDr
Jessica Bartschi
School of Psychology, Building 41, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500.
+61 2 4221 3732

Further information iconjmills@uow.edu.au
Australia

Cannabidiol for At Risk for psychosis Youth

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Trial Information

Trial summary

The proposed study aims to answer an important clinical question: can subthreshold psychotic manifestations be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa? The question has taken on increased clinical importance in the wake of recent evidence questioning the need and efficacy of specific interventions in the UHR group. This study will test CBD for the first time in the UHR phase of psychotic disorder.

Broad Health ConditionUltra-High Risk of Psychosis

Specific Health ConditionMental Health
Psychosis and personality disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA,VIC

Postcode
3052 - Parkville

Postcode
6056 - Midland

Postcode
6017 - Osborne Park

Postcode
6027 - Joondalup

Anticipated date of first participant enrolment20/06/2022

Anticipated date of last participant enrolment15/04/2025

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Aged 12-25 years (inclusive) at entry;
2.	Sufficient fluency in English (for assessment purposes);
3.	Ability to provide informed consent;(parental/guardian consent will be obtained for participants aged <18 years);
4.	Meeting one or more UHR for psychosis groups as defined in Table 1 of the study protocol and
5.	Attenuated psychotic symptoms present in the past month at UHR level as defined in Table 1 of the study protool 

Minimum age12 Years

Maximum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Ultra-High Risk symptoms only present during acute intoxication 
2.	If prescribed psychotropic medication (e.g. antidepressant medication)
3.	Pregnancy, lactation, or if sexually active, no effective contraception (applies to both male and female participants)
4.	Clinical blood test findings that might compromise participant safety or confound the trial results 
5.	Acute or unstable systemic medical disorder 
6.	Psychiatric condition due to a medical condition; 
7.	Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol 
8.	Current acute suicidality/self- harm or aggression/dangerous behaviour 
7.      Diagnosis of a serious developmental disorder or a documented history of developmental delay or intellectual disability 
9.	History of a psychotic episode of one week or longer  
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Orygen
Primary Sponsor Address: 35 Poplar Rd, Parkville VIC 3052
Primary Sponsor Country: Australia

Trial IDACTRN12621000349842

Contact person for information and recruitmentProf
Paul Amminger
Orygen, 35 Poplar Rd, Parkville VIC 3052
+61 401 846 430

Further information iconpaul.amminger@orygen.org.au
Australia

Cannabidiol (CBD) treatment for insomnia

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Trial Information

Trial summary

Insomnia is a highly prevalent and burdensome disease. It is thought to affect as many as one in three adults worldwide at any one time. Treatment options for insomnia are often limited to doctor-implemented cognitive behavioural training (CBT), pharmaceutical intervention, or a combination of the two. Whilst traditionally effective, both options have considerable limitations, most frequently those associated with cost, compliance and effectiveness (CBT), or tolerance and addiction potential (pharmaceutical). 

The Australian Federal Government recently approved the medical use of cannabinoids among select patient groups. The main active ingredient, cannabidiol (CBD), may have sedating and/or sleep-enhancing effects. There is therefore increasing global interest as its potential use as an alternate sleep-aid.

The primary objective of this research is to examine whether 2 weeks of nightly supplementation with a novel sublingual CBD-treatment improves sleep outcomes among individuals with moderate-severe insomnia. Specifically, we seek to examine the effect of treatment on subjective [sleep onset latency, sleep efficiency (%), and time awake after sleep onset] and objective sleep quality [as measured by Actigraphy outcomes (time in bed, sleep efficiency (%), number of awakenings, sleep latency) after 2-week supplementation with sublingual CBD compared with a placebo.

Broad Health Conditioninsomnia

Specific Health ConditionNeurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment2/03/2020

Anticipated date of last participant enrolment1/06/2020

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Males and Females Aged 18-45 years
2.	Insomnia Severity Index (ISI) score of 15 or more.
3.	Self-report difficulties falling and / or staying asleep (yes)
4.	Dissatisfaction with current sleep patterns (yes)
5.	Sleep problems interfering with daily life (yes)

Minimum age18 Years

Maximum age45 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Inability to speak or read English
2. Current shift worker
3. History of severe neurological, cardiac, endocrine, gastrointestinal, or bleeding disorders (self-report)
4. History of major psychiatric disorder in the past 12 months except clinically-managed mild depression
5. Severe current depression (BDI score of greater than or equal to 20)
6. Severe current anxiety (BAI score greater than or equal to 16)
7. Pregnancy or lactation - males and females shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed for female participants where necessary.
8. Use of any CNS-active drugs (including antidepressants, opioids, benzodiazepines) for the past 3 months or at the medical officer’s discretion
9. Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia
10. Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.) (self-report)
11. Used any modality of treatment for insomnia, including CBT, within 3 months before screening or at the medical doctor's discretion
12. History of drug or alcohol dependency or abuse within approximately the past 2 years (self-report and at medical officer’s discretion)
13. Probable moderate to severe obstructive sleep apnoea (STOP-BANG questionnaire)
14. Currently participating in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
15. Not willing to abstain from driving, riding, operating heavy machinery for 8 hours after taking the nightly treatment. 

The following interim exclusion criteria will occur on conclusion of the one-week placebo-run in period and prior to randomisation into the treatment arms (CBD vs placebo).
1. Placebo responder. Placebo responders will be identified and eliminated from the trial before randomisation. A placebo responder will be defined as any person entering the trial who significantly changes their subjective sleep scores derived from the sleep diary during the 7-day placebo run-in. This will be operationally defined as an individual whose:
o Subjective Sleep Efficiency (SE) goes above 85%
o Subjective Sleep Onset Latency (SOL) goes below 31 minutes
o Subjective Wake after Sleep Onset (WASO) goes below 31 minutes, as determined by the Subjective sleep information questions.

2. Non-compliers. Non-compliers will be identified as those;
a. Missing greater than or equal to 20% of the treatment doses
b. Using excessive amounts of the treatment (placebo) (greater than 20ml used).
c. Missing greater than or equal to 20% days wearing the GENEActiv wrist-mounted activity monitor over the one-week run-in period (if assigned).
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Swinburne University of Technology
Primary Sponsor Address: John St, Hawthorn VIC 3122
Primary Sponsor Country: Australia

Trial IDACTRN12620000070932

UTNU1111-1246-0810

Contact person for information and recruitmentDr
Amie Hayley
Swinburne University of Technology, Faculty of Health, Arts and Design School of Health Sciences Centre for Human Psychopharmacology Mail H24 PO Box 218 Hawthorn, Victoria, 3122
+61 3 92145585

Further information iconahayley@swin.edu.au
Australia

Clinical Study of Synthetic Cannabidiol in Children and Adolescents with 22q11.2 Deletion Syndrome

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Trial Information

Trial summary

This is an open-label single-center study, to assess the safety, tolerability and efficacy of cannabidiol administered as ZYN002, a transdermal gel, for the treatment of child and adolescent patients with 22q11.2 Deletion Syndrome (22qDS). Male and female patients with 22qDS will be treated for 14 weeks. Patients taking Anti Epileptic Drug medications will have an additional one or two week Taper Period after the completion of doing with ZYN002. Approximately 20 male and female patients, ages 6 to < 18 years, will receive ZYN002.

Broad Health ConditionPediatric 22q11.2 deletion syndrome

Specific Health ConditionNeurological
Other neurological disorders
Mental Health
Psychosis and personality disorders
Human Genetics and Inherited Disorders
Other human genetics and inherited disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Queensland Children's Hospital - South Brisbane

Postcode
4101 - South Brisbane

Anticipated date of first participant enrolment3/06/2019

Anticipated date of last participant enrolment26/02/2021

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male or female children and adolescents aged 6 to <18 years, at the time of Screening.
2.	Judged by the Investigator to be in generally good health at Screening based upon the results of a medical history, physical examination, and clinical laboratory test results.  Laboratory results outside of the reference range must be documented as not clinically significant by the Investigator.  
3.	Patients must have a diagnosis of 22qDS confirmed by genetic testing, with or without autistic features.
4.	Patients have a CGI-S score of 4 or higher at Screening and Visit 2.
5.	Patients must have a score on the ABC-C Irritability Subscale of 18 or higher at Screening and Visit 2.
6.	Patients with a history of seizure disorders must currently be receiving treatment with a stable regimen of one or two AEDs, or must be seizure-free for one year if not currently receiving AEDs.
7.	If patients are receiving non-pharmacological behavioral and/or dietary interventions, they must be stable for three months prior to Screening.
8.	Patient has demonstrated stable calcium levels for one year prior to Screening.
9.	Patients have a body mass index between 12–30 kg / m2 (inclusive).
10.	Females of childbearing potential must have a negative pregnancy test at the Screening Visit and a negative pregnancy test at all designated study visits.
11.	Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures.
12.	Patients and parents/caregivers must be adequately informed of the nature and risks of the study and give written informed consent (and assent if applicable) prior to Screening.
13.	Parents/caregiver(s) must provide written consent to assist in study drug administration.
14.	In the Investigator’s opinion, patients and parents/caregivers are reliable and willing and able to comply with all protocol requirements and procedures.

Minimum age6 Years

Maximum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Females who are pregnant, nursing, or planning a pregnancy; females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined below for the duration of therapy and for three months after the last dose of study medication.
a.	Standard acceptable methods of contraception include abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device.
2.	History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to ZYN002 or its excipients.
3.	Exposure to any investigational drug or device less than or equal to 30 days prior to Screening or at any time during the study.
4.	Patient has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels less than or equal to 2 times the upper limit of normal (ULN) or has alkaline phosphatase levels less than or equal to 3 times the ULN as determined from Screening safety laboratories.
5.	Use of cannabis or any THC or CBD-containing product within three months of Screening Visit or during the study.
6.	Patient has a positive drug screen for sympathomimetic amines (amphetamines (unless prescribed); benzodiazepines; buprenorphine; cannabinoids; methadone; cocaine (metabolites); and opiates; (excludes midazolam used at blood draws, and barbiturates used as AED medication), including ethanol.
7.	Patient is using the following AEDs: phenobarbital, ethosuximide, felbamate, or vigabatrin.
8.	Patient is using any strong inhibitor/inducer of CYP3A4 or sensitive substrate for CYP3A4 including but not limited to the following medications: midazolam (except single doses administered for the purposes of obtaining blood samples and ECG’s), oral ketoconazole, fluconazole, nefazadone, rifampin, alfentanil, alfuzosin, amiodarone, cyclosporine, dasatinib, docetaxol, eplerenone, ergotamine, everolimus, fentanyl, halofantrine, irinotecan, lapatinib, levomethadyl, lumefantrine, nilotinib, pimozide, quinidine, ranolazine, sirolimus, tacrolimus, temsirolimus, toremifene, tretinioin, vincristine, vinorelbine, and St. John’s Wort.
9.	Patient with diagnosis of known genetic disorder, other than 22qDS (i.e. Prader-Willi Syndrome, Angelman Syndrome, Fragile X Syndrome, Rett Syndrome etc.).
10.	Patient has diagnosis of DiGeorge or Velocardiofacial syndrome without the presence of 22qDS.
11.	Patient has a primary psychiatric diagnosis other than 22qDS or anxiety, including bipolar disorder, psychosis, schizophrenia, post-traumatic stress disorder (PTSD) or major depressive disorder. 
12.	Patients is on stable treatment of >6 months of not more than two psychoactive medications at screening or throughout the study (with the exception of one psychoactive medication prescribed for sleep). 
13.	Patient has an advanced, severe, or unstable disease that may interfere with the study outcome evaluations.
14.	Patient is expected to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
15.	Patient has an acute or progressive neurological disease, or any psychiatric disorder or severe mental abnormalities that are likely to require changes in drug therapy or interfere with the objectives of the study or ability to adhere to protocol requirements.
16.	Patient has a positive result for the presence of HBsAg, HCV, or HIV antibodies.
17.	Patients at risk of needing cardiovascular surgical repair within the upcoming 12 months.
18.	Patient has unstable cardiovascular disease, such as advanced arteriosclerosis, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), other serious or other clinically unstable  cardiac problems.
19.	Clinically unstable cardiovascular disease as indicated by history, physical examination or ECG. 
20.	Presence of a moderate or severe surgically uncorrected structural cardiac abnormality.
21.	History of major congenital  heart disease including those who had surgical repair.  Congenital heart disease is defined by classification of complex (fontan circulation, hypoplastic left heart, double inlet ventricle, double outlet right ventricle, Eisenmenger’s syndrome, mitral atresia, tricuspid atresia, pulmonary atresia (with or without intact ventricular septum) , congenitally corrected transposition of great arteries, complete atrioventricular septal defect, truncus arteriosus, other single ventricle physiology, other cyanotic congenital heart disease), moderate (transposition of great vessels, tetralogy of fallot, total or partial anomalous pulmonary venous drainage, Ebstein’s anomaly, coarctation of aorta, aortic stenosis, pulmonary stenosis, ostium primum atrial septal defect, sinus of valsalva fistula/aneurysm) or simple (ventricular septal defect, atrial septal defect, persistent ductus arteriosus, mild pulmonary stenosis).
22.	Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study medication.
23.	Any skin disease or condition, including eczema, psoriasis, melanoma, acne, contact dermatitis, scarring, imperfections, lesions, tattoos, or discoloration, that may affect treatment application, application site assessments, or absorption of the study drug.
24.	History of treatment for, or evidence of, drug abuse within the past year.
25.	Patient responds “yes” to Question ‘4’ or ‘5’ on the C-SSRS (Children) during Screening or at any time on study.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zynerba Pharmaceuticals Pty Ltd
Primary Sponsor Address: 2 Riverside Quay Southbank, VIC 3006
Primary Sponsor Country: Australia

Trial IDACTRN12619000673145

Contact person for information and recruitmentDr
Nancy R Tich
Zynerba Pharmaceuticals Inc., 80 West Lancaster Ave., Suite 300, Devon, PA 19333
+1-973-727-4117

Further information icontichn@zynerba.com
United States of America

An open label, study to evaluate the safety of Cannabidiol (CBD) for the prevention of Acute Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic cell transplantation.

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Trial Information

Trial summary

The purpose of this study is to evaluate the safety of cannabidiol (CBD) for the prevention of Acute Graft-Versus-Host Disease (GVHD) in patients who are undergoing allogeneic hematopoietic cell transplantation.

Who is it for?
You may be eligible for this study if you are aged 18 or older, and are undergoing a allogeneic hematopoietic stem cell transplantation (HSCT).
Study details
Participants in this study will consume a solution of cannabidiol (CBD) in olive oil by mouth twice per day from the time transplant procedures commence until 98 days post-transplant. The concentration of CBD will vary depending on when you enrol in the study. As part of his study, all participants will have blood and urine tests, and undergo physical examinations, in addition to standard post-transplant tests.

It is hoped this research might provide some evidence that CBD can prevent acute Graft Versus Host Disease (GVHD) in patients that have undergone an allogeneic HSCT, including how it is tolerated, absorbed and interacts within the body.

Broad Health ConditionAcute Graft Versus Host Disease
Hematopoietic Stem Cell Transplantation

Specific Health ConditionCancer
Other cancer types
Blood
Haematological diseases

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Trial location outside Australia

Country
Israel

Anticipated date of last participant enrolment30/04/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Any malignant hematological disease in CR or Myelodysplastic Syndrome (MDS)
2.	Age greater than or equal to 18 years 
3.	Karnofsky Score (KS) greater than or equal to 60% 
4.	HSCT-Comorbidity Index (HSCT-CI) score less than or equal to 3
5.	No major organ dysfunction
6.	Myeloablative or reduced intensity conditioning regimen
7.	matched (7/8 or 8/8) unrelated donor 
8.	Peripheral blood stem cell graft
9.	Subject’s written informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Malignant hematological disease, other than MDS, not in CR
2.	Myelofibrosis
3.	Allogeneic transplantation from a matched or mismatched sibling donor 
4.	Cord blood transplantation
5.	Positive serology for HIV
6.	Serious psychiatric or psychological disorders
7.	Any uncontrolled infection at time of registration
8.   Study subjects must not be pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the trial, as well as within 30 days after the anticipated date the subjects would complete the study. 
9.	Active consumption of illicit drugs (such as: Crack cocaine, Heroin, Methamphetamines, Cocaine, Bath Salts, Amphetamines, Methadone, Benzodiazepine, Marijuana, Ecstasy)
10. Use of Cannabis and/or its derivatives fourteen days prior to HSCT and for the duration of study participation 
11. QTc greater than 450ms per Friderica's correction and impaired cardiac  function or clinically significant cardiac disease
12. Inadequate renal function defined as measured creatinine clearance greater than 2.0 mg/dl
13. Liver enzymes: ALT and AST greater than 3 times the upper limit of normal
14. Pregnant or breastfeeding (positive serum beta-HCG 7 days before first dose)
15. Treatment with another investigational drug, biological agent, or device within 30 days of first dose, or investigational cell therapy within 6 months of first dose..

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Kalytera Therapeutics Israel Ltd
Primary Sponsor Address: Technology Building, Road #4 Katzrin 1290005, Israel
Primary Sponsor Country: Israel

Trial IDACTRN12619000623190

UTNU1111-1229-9861

Contact person for information and recruitmentMs
Toula Papadodimitrakis
Salzman Group CRO 270 Ferntree Gully Road Notting Hill Vic 3168
+613 8375 7156 ext 2601

Further information icontoula@salzgrp.com
Australia

A study to evaluate the effect of food on the pharmakokinetics and cardiac function in male and female healthy volunteers who have been administered cannibidiol.

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Trial Information

Trial summary

This research project is being conducted to investigate the safety and tolerability of multiple doses of cannabidiol (CBD) when administered to healthy volunteers.

Broad Health ConditionAcute Graft Versus Host Disease

Specific Health ConditionInflammatory and Immune System
Other inflammatory or immune system disorders

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Nucleus Network - Melbourne

Postcode
3004 - Melbourne

Anticipated date of last participant enrolment24/05/2019

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Healthy adult subjects =18 – 60 years of age
2.	Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive and a minimum weight of at least 50 kg at screening and not more than 100 kg at screening
3.	Non-users of tobacco or nicotine-containing products (minimum of 4 weeks from admission)
4.	Subjects with reproductive potential required to practice abstinence or be using and willing to continue using a medically acceptable form of birth control for at least one month prior to screening (at least 3 months for oral contraceptives) and for at least 60 days after the last study drug administration.
5.	Free from any clinically significant abnormality based on medical history, vital signs, physical examination, ECG, and laboratory evaluation at screening and admission to the treatment session, as judged by the investigator or designee.
6.	Systolic blood pressure between 90 to 140 mmHg and diastolic blood pressure between 50 and 90 mmHg at screening and admission to the treatment session.
7.	Male Participants who agree to the following during their participation in this study and for at least 1 month after the last dose of study intervention: Refrain from donating sperm PLUS either: 
o	Be abstinent from heterosexual [or homosexual] intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below: 
o	Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
8.	A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
o	Is not a woman of childbearing potential (WOCBP) OR
o	Is able to abstain from heterosexual intercourse if it is in keeping with her preferred and usual lifestyle (such as participants with same-sex partners)
OR
o	Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), during the intervention period and for at least 30 days plus 30 days (a menstrual cycle) after the last dose of study intervention [and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.]. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
o	A WOCBP must have a negative pregnancy test [ serum] as required by local regulations) within [24 hours] before the first dose of study intervention.
9.	Subjects must be able to speak, read and understand English sufficiently to understand the nature of the study and provide written informed consent
10.	Subjects must be capable of giving signed informed consent and agree to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
11.	Subjects must have understood and provided written informed consent prior to initiation of any protocol-specific procedures.

Minimum age18 Years

Maximum age60 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1.	History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal or other major disease as determined by the Investigator and/or Sponsor’s Medical Monitor
2.	Evidence of disease that may influence the outcome of the study within 4 weeks before dosing as determined by the Investigator and/or Sponsor’s Medical Monitor
3.	Any history of gastrointestinal surgery that may affect the pharmacokinetic profile of the study drug
4.	Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG findings or laboratory test results that requires medical treatment at Screening or Baseline
5.	History of any medical condition which, in the opinion of the Investigator, may interfere with study procedures or compromise subject safety (e.g. psychiatric illness, disability or social situation)
6.	Known history of clinically significant drug allergy (including to study drugs or any of their excipients) at Screening or Baseline
7.	Known history of clinically significant food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
8.	Active viral hepatitis (B or C) and HIV as demonstrated by positive serology at Screening 
9.	Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones) 
10.	Alanine transaminase (ALT) >1.5x upper limit of normal (ULD)
11.	Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if fractionated and direct bilirubin <35%)
12.	Persistent systolic blood pressure (BP) > 140 mmHg or < 90 mmHg and diastolic BP >90mmHg or <40mmHg at Screening or Baseline
13.	Heart rate <50 or >100 beats/minute at Screening
14.	History of prolonged QT/QTc interval
15.	A history of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/QTc interval
16.	Corrected QT interval (QTc) >450 milliseconds (msec) (for males) or >470 msec (for females)
•	The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or manually over-read
•	The specific formula that will be used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.
•	For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used 
17.	A history of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
18.	History of myocardial infarction or active ischemic heart disease
19.	History of clinically significant arrhythmia or uncontrolled arrhythmia
20.	Intake of caffeinated beverages or food within 72 hours before dosing
21.	Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (e.g. grapefruit, grapefruit juice, apple or orange juice, vegetables from the mustard green family) within 1 week before dosing. Alcohol within 72 hours of dosing.
22.	Intake of herbal preparations containing St. John’s Wort within 4 weeks before dosing
23.	Past or intended use of over-the-counter (OTC) or prescription medications 2 weeks before first dosing unless agreed by the Investigator and Sponsor’s Medical Monitor to not be clinically relevant
24.	Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study 
25.	Regular alcohol consumption within 3 months prior to the study defined as: 
•	An average weekly intake of >14 units for males and females. One unit is equivalent to 8g of alcohol: pot of beer (~240mL), 1 glass (125mL) of wine or 1 (25mL) measure of spirits
26.	History of drug or alcohol dependency or abuse within the 2 years before Screening, or who have a positive urine drug or alcohol test at Screening or Baseline
27.	Engagement in strenuous exercise within 72 hours before dosing 
28.	Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study. 
29.	Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent 
30.	A subject who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Kalytera Australia Pty Ltd
Primary Sponsor Address: Level 4, 68 Georges Terrace Perth, WA 6000 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12619000443190

UTNKAL07

Contact person for information and recruitmentMs
Antu Mishra
Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne 3004 VIC
+61 3 8593 9259

Further information icona.mishra@nucleusnetwork.com.au
Australia

Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in New South Wales (NSW)

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Trial Information

Trial summary

The main purpose of this study is to determine what dose and frequency of medicinal cannabis is the best to relieve key symptoms in people with advanced cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of advanced cancer, with significant symptoms of severe pain, and/or vomiting, and/or nausea and/or lack of appetite that are poorly controlled by usual treatments, and a predicted life expectancy of more than 3 months and less than 12 months.

Study details
All participants in the study will be prescribed one of a number of cannabis medicines. The cannabis product will be given in addition to the usual treatments for their advanced cancer symptoms. On the first day of treatment participants will have 5 blood samples collected over 4 hours to measure the levels of cannabis medicines in their blood. They will also complete some online questionnaires about how they feel and be monitored for side effects.

Participants will remain enrolled in this trial and receive the cannabis medication prescribed at no cost until they are no longer able to take it or withdraw from the trial. Participants will be asked to complete regular online questionnaires and have a single blood sample taken every few weeks when they see the trial doctor, until they no longer receive the product and/or withdraw from the trial.

It is hoped the information collected in this study will guide the use of cannabis medicines to control symptoms in people with advanced cancer.

Broad Health ConditionCancer
Pain
Anorexia
Nausea

Specific Health ConditionCancer
Any cancer
Anaesthesiology
Pain management

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Orange Health Service - Orange

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Liverpool Hospital - Liverpool

Hospital
Westmead Hospital - Westmead

Hospital
Prince of Wales Hospital - Randwick

Hospital
Gosford Hospital - Gosford

Hospital
Wyong Public Hospital - Hamlyn Terrace

Hospital
Tamworth Rural Referral Hospital - Tamworth

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Wollongong Hospital - Wollongong

Hospital
Shoalhaven Hospital - Nowra

Hospital
Macquarie University - North Ryde

Postcode
2800 - Orange

Postcode
2050 - Camperdown

Postcode
2170 - Liverpool

Postcode
2145 - Westmead

Postcode
2031 - Randwick

Postcode
2250 - Gosford

Postcode
2259 - Hamlyn Terrace

Postcode
2340 - Tamworth

Postcode
2010 - Darlinghurst

Postcode
2500 - Wollongong

Postcode
2541 - Nowra

Postcode
2109 - North Ryde

Anticipated date of first participant enrolment25/02/2020

Anticipated date of last participant enrolment1/02/2023

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Aged 18 years or older.
2. Has provided written Informed Consent for participation in this trial.
3. Confirmed advanced cancer (any) with or without stable disease.
4. Predicted life expectancy of 3 to 12 months at time of consent, as estimated by the study investigator and confirmed by an additional qualified clinician, independent of the trial.
5. Persistent symptoms of anorexia, nausea or refractory pain, which in the investigator’s opinion are not responsive to implementation of standard practice, and who are ineligible or not wishing to be involved in other clinical trials of cannabis medicines.
6. Willing and able, in investigator’s opinion, to comply with all trial requirements, including keeping a patient diary, completing clinical measurement scales and having pharmacokinetic samples collected as per Participant Information Sheet. Note: completion of these trial requirements is essential and intentional non-compliance may cease access to trial product and will be managed on a case-by-case basis. Non-compliance due to declining health is unintentional and it is hoped unintentional noncompliance due to declining health may be minimised through optional proxy completion of patient reported outcomes and patient diary.
7. Available to attend Trial Site for follow up and collection of investigational product.
8. Participants (and/or partners) capable of childbearing are using adequate contraception.

Participants are able to continue to receive standard concomitant care and interventions, such as chemotherapy and radiotherapy, and take medications for other conditions as usual in the advanced care population

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Lack of capacity to consent.
2. Unwilling to keep a Patient Diary, attend follow up appointments, complete clinical measurement scales or have pharmacokinetic samples. 
3. History of schizophrenia, other psychotic illness, severe borderline personality disorder, or other significant psychiatric disorder other than depression or anxiety associated with underlying condition. Delirium is an excluded condition.
4. Previous severe adverse event to any cannabinoid product, such as cannabis related psychosis, panic attack, palpitations.
5. A diagnosed substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, cannabis, benzodiazepines, or illicit stimulants. Nicotine and caffeine are excluded. 
6. Known allergy to cannabis or other ingredient of cannabis medicine e.g. carrier oil.

Note: Prior access to authorised cannabis medicines or current use of illicit cannabis is not an exclusion, unless associated with a serious adverse event (SAE) or substance use disorder as per exclusion criteria above.
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Health Administration Corporation acting through the NSW Ministry of Health
Primary Sponsor Address: Medical Advisor Office of the Chief Health Officer, NSW Health 73 Miller Street North Sydney NSW 2060
Primary Sponsor Country: Australia

Trial IDACTRN12619000265178

UTNU1111-1227-1657

Contact person for information and recruitmentDr
Rachel Galettis
Clinical Trial Coordinator ACRE C/- Hunter Medical Research Institute Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305
+61 2 40420915

Further information iconACRE-CARE@newcastle.edu.au
Australia

A study that evaluates the effectiveness of oral combined THC/CBD for people with advanced cancer experiencing a range of symptoms.

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Trial Information

Trial summary

The purpose of this study is to assess whether delta-9-tetrahydrocannabinol (THC) and cannabidoil (CBD) can be used to reduce total symptoms in patients with advanced cancer in palliative care.

Who is it for?

You may be eligible for this study if you are over 25 years of age and have been diagnosed with advanced cancer.

Study details

Participants will be randomly assigned to one of two treatment groups; either THC/CBD or a placebo medication. 

Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. 

During the 28 days of the study you will be required to have routine bloods and urine test which will be used as part of the eligibility and post trial analysis 

It is hoped that this research will show a positive effect of THC/CBD on symptoms for patients suffering with advanced cancer and thus provide an option in helping manage symptoms.

Broad Health ConditionCancer
Fatigue
Nausea
Breathlessness
Appetite
Psychological effects

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Mater Private Hospital - South Brisbane

Hospital
St Vincent's Hospital Brisbane - Kangaroo Point

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Gold Coast Hospital - Southport

Postcode
4101 - South Brisbane

Postcode
4169 - Kangaroo Point

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Postcode
4215 - Southport

Anticipated date of first participant enrolment1/04/2019

Anticipated date of last participant enrolment1/04/2022

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:

- have an ESAS TSDS greater than 10 for cancer-related symptoms*
- at least one individual ESAS score greater than 3
- AKPS score >30
- aged >25yrs and above. English speaking (or have interpreter available)
- have a negative pregnancy urine test at eligibility (only if of reproductive potential) and 
  agree to avoid pregnancy during the study and 12 weeks following the last dose of the 
  study drug. Males must agree to avoid fathering a child and to not donate sperm during 
  the study and for at least 12 weeks following the last dose of the study drug
- have a negative THC urine test
- able to tolerate oral medication 
- willing to receive standard palliative care
- comply with trial requirements; agree to attend scheduled clinic appointments, adhere to dose 
   titration schedule as directed
- agree to use no other cannabis based products for the duration of the trial
- understand it is illegal to drive whilst taking THC containing cannabis products, to take 
  cannabinoid products outside of Australia or to endorse legal documents whilst taking THC 
  containing cannabis products
- provide fully informed consent
*physician assessed

Minimum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients with:

- a history of hypersensitivity to any cannabinoid product
- unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive 
  cardiac failure)
- severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal 
  range. Asparate aminotransferase (AST), and alanne aminotransferase (ALT) >3.0 time the upper 
  limit of the institution's normal range; subjects with liver metastasis may have an AST and ALT of 
  >5.0 times the upper limit of normal
- severe renal impairment (eGFR <20mls/min/1.73m2)
- history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, 
  schizophrenia, first degree relative with schizophrenia and/or suicidal ideation)
- cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30
- known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening 
  Test) examination score >27+ 
- history that drug diversion may be a risk for them or their family/carers
- females who are pregnant or lactating
- concurrent or participation of a new clinical entity with the last 28 days
- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or 
  radiation within the last 7 days
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Mater Misericordiae Limited
Primary Sponsor Address: Mater Misericordiae Ltd Raymond Terrace South Brisbane Qld 4101
Primary Sponsor Country: Australia

Trial IDACTRN12619000037101

Contact person for information and recruitmentMrs
Georgie Huggett
Clinical Trial Coordinator Palliative and Supportive Care Mater Misericordiae Ltd Raymond Terrace South Brisbane, Qld 4101
+61 7 3163 6057
+61 7 6163 1588
Further information icongeorgie.huggett@mater.org.au
Australia

Clinical study Of caNNabidiol in children and adolesCenTs with Fragile X Open-Label Extension (CONNECT-FX OLE)

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Trial Information

Trial summary

This study is evaluating the long term and safety and tolerability of ZYN002, a clear gel that can be applied to the skin (called transdermal application) twice a day for treatment of symptoms of Fragile X Syndrome (FXS)

Who is it for?
Patients who have been diagnosed with Fragile X Syndrome and are aged between 3 and 18 years old who have participated in the ZYN2-CL-016 double-blind study and meet certain eligibility criteria.

Study details
Eligible participants will undergo up to a 52-week treatment period. Participants who are taking anti-epileptic drugs may undergo an additional 1-2 weeks of treatment to taper off study drug treatment.  All participants will be assigned to ZYN002. Parents/ caregivers will be instructed on proper application of the gel. The gel will be applied to clean, dry, intact skin of the upper arms/ shoulders. 

Participants whose weight changes during the course of the study may have their doses changed at the investigator’s discretion on or after the Month 1 visit, or reduced due to tolerability issues at investigator’s discretion.

Blood samples will be collected for safety analysis of ZYN002.   Additionally, the parents/caregivers will be asked to complete some questionnaires. There will be other questionnaires and scales that will be completed at the site by the study doctor and/or with the participant and their parents/caregivers.

Participation in this study may help the child’s/ adolescent’s FXS symptoms; however, we cannot guarantee that he/ she will get any benefits from this study. The results of this study may benefit future patients.

Broad Health ConditionFragile X Syndrome

Specific Health ConditionHuman Genetics and Inherited Disorders
Other human genetics and inherited disorders
Neurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Hospital
Lady Cilento Children's Hospital - South Brisbane

Hospital
Fragile X Alliance Inc. - Caulfield North

Hospital
The Children's Hospital at Westmead - Westmead

Postcode
4101 - South Brisbane

Postcode
3161 - Caulfield North

Postcode
2145 - Westmead

Trial location outside Australia

Country
United States of America

State
Multiple Sites

Country
New Zealand

State
Wellington

Anticipated date of last participant enrolment30/09/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Participated in a certain number of visits in the ZYN2-CL-016 study
2.	Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures.
3.	Patients and parents/caregivers must be adequately informed of the nature, risks of the study, and give written informed consent prior to enrollment in ZYN2-CL-017.
4.	In the Investigator’s opinion, the patients and parents/caregivers are reliable and are willing and able to comply with all protocol requirements and procedures.
5.	Females of childbearing potential must have a negative pregnancy test at all designated visits

Minimum age3 Years

Maximum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Patient is receiving any investigational drugs (not ZYN002) or using any experimental devices.
2.	Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in ZYN2-CL-016, which in the opinion of the Investigator, should exclude them from participation. 
3.	Females who are pregnant, nursing, or planning a pregnancy; females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined below for the duration of therapy and for three months after the last dose of trial drug. 
4.	Patients who have alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels = 2 times the upper limit of normal (ULN) or has alkaline phosphatase levels = 3 times the ULN as determined from patient safety laboratories.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zynerba Pharmaceuticals Pty. Ltd
Primary Sponsor Address: 2 Riverside Quay Soutbank, VIC 3006
Primary Sponsor Country: Australia

Trial IDACTRN12618001868279

Contact person for information and recruitmentDr
Nancy R. Tich
Zynerba Pharmaceuticals Inc.,80 West Lancaster Ave., Suite 300, Devon, PA 19333
+1-973-727-4117

Further information iconTichn@zynerba.com
United States of America

Clinical study of Cannabidiol in children and adolescents with Developmental and Epileptic Encephalopathy

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Trial Information

Trial summary

A sequential, multi-stage, open-label, multi-national, multiple-center, multiple-dose study to assess the long-term safety and tolerability of ZYN002 (transdermal CBD gel) in child and adolescent epilepsy patients 3 to <18 years of age with seizures associated with developmental and epileptic encephalopathies (DEE) according to the International League Against Epilepsy (ILEA) classification.
In Period A patients will undergo a baseline period of 4-weeks, followed by a 2-week titration period, and a 24-week maintenance period. Patients will be treated for a total of 26 weeks. For Patients not continuing to Period B, following Week 26 or Early Termination, study drug will be tapered over a 1 to 3-week period (depending on dose). After the final dose, patients will be followed weekly for 4 weeks by telephone.  After the 4 weeks, the patient will be discharged from the study. 
Patients progressing to Period B will continue to receive ZYN002 for a further 24 weeks at the same maintenance dose received at Week 26 (e.g. end of Period A). Upon treatment termination, the patient will be required to complete the taper and follow-up period.  After the final tapered dose, patients will be followed weekly for 4 weeks by telephone.  After the 4 weeks of follow-up, the patient will be discharged from the study.

Broad Health ConditionEpilepsy
Developmental disability

Specific Health ConditionNeurological
Epilepsy
Neurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Austin Health - Austin Hospital - Heidelberg

Postcode
3084 - Heidelberg

Trial location outside Australia

Country
New Zealand

State
Wellington

Anticipated date of first participant enrolment9/04/2018

Anticipated date of last participant enrolment14/12/2018

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Male or female, 3 to  less than 18 years of age, inclusive, at the time of screening.
2. Judged by the Investigator to be in generally good health at the Screening Visit based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. 
3. Patients must have a diagnosis of developmental and epileptic encephalopathy (DEE) as defined by the International League Against Epilepsy Classification (Scheffer 2017) with generalized motor, focal motor and focal impaired awareness or focal bilateral to tonic-clonic seizures. Examples of DEE that may be included, but not limited to: Lennox-Gastaut Syndrome, Dravet Syndrome, West Syndrome/ Infantile Spasms and Doose Syndrome. The diagnosis must be established for 1 years and documented by review of electroencephalogram (EEG), , and or genetic testing if available, and narrative from the physician who manages the patient’s epilepsy. The patient/legally authorized representation may elect to have the patient participate in genetic seizure panel testing to characterize a genetic diagnosis.
4. Patient must experience a threshold number of generalized motor seizures (i.e. tonic, clonic, atonic, tonic-clonic seizures, and generalized tonic-clonic), focal motor, focal impaired awareness or focal to bilateral tonic-clonic seizures during the Baseline period.
5. Patient is currently being treated and maintained with a stable regimen of between one (1) and four (4) AEDs for at least 4 weeks before screening, and willing to maintain a stable regimen during the treatment period. If a benzodiazepine is used as a rescue medication greater than 2 times per week, it will be counted as an AED. Patient taking ethosuximide, felbamate and vigabatrin must be on stable therapy for at least 6 months. Patient taking felbamate must have had no clinically relevant changes in hematology or liver function.
6. Patient has history of developmental delay with regression, slowing or plateau in at least one developmental domain. 
7. All interventions for epilepsy must be stable for at least one month prior to screening. 
8. Patient/caregiver is able and willing to maintain daily diaries for seizures, daily skin assessments and good day/bad day assessment.
9. Patient has a body mass index between 13 and 35 kg/m2 and weighs no less than 12 kg.
10. Sexually active females of childbearing potential must use an acceptable method of contraception. Acceptable methods of contraception include: hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, and intrauterine device.
11. Females of childbearing potential must have a negative pregnancy test at the Screening Visit, as well as at Day 1. 
12. Patient is reasonably stable medically and is unlikely to require changes in drug therapy during the Treatment Period of the study, or interfere with the objectives of the study, or the ability to adhere to protocol requirements.
13. Patient/caregiver/legally authorized representative must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
14. In the Investigator’s opinion, the patient and/or caregiver is reliable and is willing and able to comply with all protocol requirements and procedures.

Minimum age3 Years

Maximum age17 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Patient has a history of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients.
2. Patient has been exposed to any investigational drug or device less than 30 days prior to screening or plans to take another investigational drug at any time during the study.
3. Patient has used cannabis or any CBD- or THC-containing product within 12 weeks of the Screening Visit or during the study.
4. Patient on the following AEDs for less than 6 months: ethosuximide, felbamate and vigabatrin.
5. Patient has had a change in AED regimen in the 4 weeks prior to screening. 
6. Patient has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels equal to 3x the upper limit of normal (ULN) as determined from Screening safety laboratories.
7. Patient/caregiver demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. 
8. Patient has had a change in epilepsy dietary therapy in the 4 weeks prior to screening.
9. Patient has seizures secondary to illicit drug or alcohol use. 
10. Patient is using any strong inhibitor/inducer of CYP3A4 or sensitive substrate for CYP3A4 including the following medications: midazolam, oral ketoconazole, fluconazole, nefazodone, rifampin, alfentanil, alfuzosin, amiodarone, cyclosporine, dasatinib, docetaxel, eplerenone, ergotamine, everolimus, fentanyl, halofantrine, irinotecan, lapatinib, levomethadyl, lumefantrine, nilotinib, pimozide, quinidine, ranolazine, sirolimus, tacrolimus, temsirolimus, toremifene, tretinoin, vincristine, vinorelbine and St. John’s Wort.
11. Patient has a history of suicide attempt in the last 5 years or more than one lifetime suicide attempt. 
12. Patient responds “yes” to Question 4 or 5 of C-SSRS (Children) during Screening and at any time during the study.
13. Patient has a positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies.
14. Patient has any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study treatment.
15. Patient has known history of cardiac disease.  
16. Patient has any skin disease or condition, including eczema (on shoulders/arms, back or thighs), psoriasis, melanoma, acne (on shoulders/arms/back or thighs), contact dermatitis, scarring, imperfections, lesions, tattoos, or discoloration that may affect treatment application, application site assessments, or absorption of the study drug.

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zynerba Pharmaceuticals Pty Ltd
Primary Sponsor Address: Zynerba Pharmaceuticals Pty Ltd Offices of Pricewaterhouse Coopers 2 Riverside Quay Southbank VIC 3006
Primary Sponsor Country: Australia

Trial IDACTRN12618000516280

Contact person for information and recruitmentDr
Nancy R. Tich, Ph.D.
Zynerba Pharmaceuticals Pty, Ltd. 80 West Lancaster Ave., Suite 300, Devon, Pennsylvania
+1-973-727-4117

Further information icontichn@zynerba.com
United States of America

CannabisCINV: A placebo-controlled trial evaluating an oral THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting in patients of any known malignancy receiving chemotherapy.

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate the efficacy of an oral capsule containing plant-derived tetrahydrocannbinol (THC) and cannabidiol (CBD) for the prevention of chemotherapy-induced nausea and vomiting (CINV). 

Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with any cancer for which you are scheduled to receive at least three further chemotherapy cycles using intravenous chemotherapy of high or moderate emetic risk.

Study details
We will first enrol 80 participants in a pilot trial and if the data from these participants shows the medicine works and is well tolerated, a further 170 participants will be enrolled, this is called the definitive trial.

Participants enrolled in the pilot trial will be randomly allocated (by chance) to receive the study drug for the first five days of their first chemotherapy cycle following enrolment, followed by a placebo capsule for the first five days of the next chemotherapy cycle, or to receive the placebo first followed by the study treatment. All participants will then choose which treatment they would prefer to take for the first five days of the third chemotherapy cycle. Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. 

Participants enrolled in the definitive trial will be randomly allocated (by chance) to receive the study drug or the placebo for the first five days of their next three chemotherapy cycles following enrolment, Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. 

It is hoped that this trial will provide preliminary information on the efficacy of THC and CBD capsules for the prevention of CINV, which will inform further clinical trials.

Broad Health ConditionChemotherapy induced nausea and vomiting
Cancer

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Concord Repatriation Hospital - Concord

Hospital
Coffs Harbour Base Hospital - Coffs Harbour

Hospital
Wollongong Hospital - Wollongong

Hospital
Orange Health Service - Orange

Hospital
St George Hospital - Kogarah

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Campbelltown Hospital - Campbelltown

Hospital
The Tweed Hospital - Tweed Heads

Hospital
Southern Highlands Private Hospital - Bowral

Hospital
Gosford Hospital - Gosford

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Gold Coast University Hospital - Southport

Hospital
Sydney Adventist Hospital - Wahroonga

Hospital
John Flynn - Gold Coast Private Hospital - Tugun

Hospital
The Northern Beaches Hospital - Frenchs Forest

Postcode
2050 - Camperdown

Postcode
2139 - Concord Repatriation Hospital

Postcode
2450 - Coffs Harbour

Postcode
2500 - Wollongong

Postcode
2800 - Orange

Postcode
2217 - Kogarah

Postcode
2065 - St Leonards

Postcode
2560 - Campbelltown

Postcode
2485 - Tweed Heads

Postcode
2576 - Bowral

Postcode
2250 - Gosford

Postcode
5042 - Bedford Park

Postcode
4215 - Southport

Postcode
2076 - Wahroonga

Postcode
4224 - Tugun

Postcode
2086 - Frenchs Forest

Anticipated date of first participant enrolment30/11/2016

Anticipated date of last participant enrolment30/10/2023

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Adults, aged 18 years and older, with known malignancy of any stage
2.	Receiving intravenous chemotherapy of high or moderate emetic risk as defined by MASCC criteria on Treatment Day 1 administered in cycles of planned duration greater than or equal to 14 days and less than or equal to 21 days
Note:
-	Chemotherapy agents classified as low and/or minimal emetic risk may be used concurrently throughout the treatment period (acceptable combination regimens include but not limited to: FOLFOX, carboplatin day 1 and gemcitabine day 1 and 8)
-	Multi-day use of chemotherapy of high or moderate emetic risk is permitted up until but not beyond day 5 is permitted, when the continuation of the chemotherapy is part of the overall Day 1 regimen (acceptable multi-day regimens include but not limited to: BEP, TIP; unacceptable multi-day regimens include but not limited to: weekly cisplatin, weekly carboplatin, cisplatin day 1 & 8 with gemcitabine day 1 & 8, MVAC)
-	Concurrent oral chemotherapy and radiotherapy are not permitted 
3.	Requires greater than or equal to 2 further cycles of chemotherapy
4.	Experiencing significant CINV during previous cycle 1
-	defined as need for rescue medications for vomiting or distress by nausea, and/or greater than or equal to moderate nausea on 5-point rating scale, despite best-practice MASCC guideline-consistent anti-emetic regimen
5.	ECOG performance status of 0, 1 or 2
6.	Predicted life expectancy of greater than or equal to 4 months
7.	Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments including diary, quality of life forms, urine tests, and any mandated blood tests
8.	Signed, written informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Symptomatic primary or secondary CNS malignancy
2.	Symptomatic gastrointestinal obstruction
3.	Disease-related nausea or vomiting requiring daily anti-emetic therapy
4.	Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure)
5.	History of epilepsy or recurrent seizures
6.	History of schizophrenia, other psychotic illness, severe personality disorder, suicidal ideation, or other significant psychiatric disorder, other than depression associated with underlying condition
7.	Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants
8.	Serious medical or psychiatric condition that might limit the ability of the patient to consent to the study and/or comply with the protocol
9.	Scheduled to receive oral chemotherapy during planned duration of study
10.	Patient has received or is scheduled to receive radiation therapy to the brain, abdomen or pelvis in the week prior to commencement of study treatment, or during study treatment
11.	Is scheduled to receive any investigational drug during the present study
12.	Patients using or having used cannabis or cannabinoid based medications within 30 days of study entry and unwilling to abstain for the duration of the study
13.	Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications, 5HT3 antagonist, dexamethasone, NK1 antagonist
14.	Unwilling to avoid driving or operating machinery during and for 72 hours after taking study medication
15.	Concerns regarding safe storage of study medication (eg. unsuitable home environment)
16.	Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
17. Patients who were previously enrolled in this study and received the study intervention (oral THC/CBD and/or placebo)
18. Patients who declare they have been convicted of a criminal offence.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Sydney
Primary Sponsor Address: Campderdown NSW 2050
Primary Sponsor Country: Australia

Trial websitehttps://ctc.usyd.edu.au/our-work/research-divisions/cancer/cancer-divisions/other-research/open-trials/cannabiscinv/

Trial IDACTRN12616001036404

Contact person for information and recruitmentMs
Trial Coordinator
Organisation: University of Sydney NHMRC CTC, Level 6 Chris O Brien Lifehouse, 119–143 Missenden Road, Camperdown NSW 2050
+61295625000

Further information iconcannabiscinv.study@sydney.edu.au
Australia

Cannabiol (CBD) for Cannabis and Mood Disorders in Young Adults (CCAMDYA)

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Trial Information

Trial summary

The primary objectives of the study is to examine the feasibility, safety and efficacy of cannabidiol (CBD) in the management of concurrent mood and cannabis use disorders in young people, in a randomized controlled study. Specifically, the study will assess recruitment rates,  retention rates, adverse events, the quantity and frequency of cannabis use, and the impact of CBD on patient mental health outcomes and well-being. 
Current treatments for anxiety and depression are of limited efficacy in a considerable proportion of patients (30% of depressed patients are pharmacoresistant) and are associated with troublesome side effects that reduce compliance; the development of novel, improved therapeutic treatments would fill a considerable unmet medical need. CBD has emerged as one of the most promising candidates in treating psychiatric disorders. Research suggests that greater rates of mental health problems in cannabis users are related to increased use of high THC/low CBD varieties of cannabis. In various animal and human laboratory and clinical studies, CBD has been found to reduce the intoxicating and psychotomimetic effects of THC, while CBD given alone has also been found to relieve anxiety and nausea and to have anti-inflammatory and antipsychotic effects.
Thirty participants (male and female) will be recruited over a period of 9 months. The study will be conducted in the Department of Addiction Medicine at St Vincent's Hospital Melbourne. Participants will complete an initial assessment  as per normal clinical practice. Eligible participants will be contacted to attend a baseline assessment and informed consent..  Participants will be randomized into either a CBD or placebo treatment group for a period of 12 weeks with follow-up at 14 weeks. All participants will be offered up to 6 sessions of manualised psychotherapy as per standard clinical practice.

Broad Health ConditionMood disorders
Cannabis use

Specific Health ConditionMental Health
Depression
Mental Health
Addiction

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Postcode
3065 - Fitzroy

Anticipated date of first participant enrolment1/03/2022

Anticipated date of last participant enrolment1/11/2022

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

•	At least greater than or equal to 18 years of age & less than 28 years of age at presentation.
•	Moderate to severe DSM 5 Cannabis Use Disorder 
•	Cannabis use on average at least greater than or equal to 3 days per week (over last 28 days).
•	Desire to reduce or cease cannabis use 
•	Moderate to severe depression, indicated by a score greater than or equal to 11 and less than or equal to 20 on the QIDS-C at first contact with the service.
•	A diagnosis of a mood disorder with or without psychotic features at baseline using a structured clinical interview.
•	Fluent in English.
•	Able to give informed consent. 
•	Agree to participate in all tests, including urine and saliva drug screens.
•	Prepared to take trial medications as requested.

Minimum age18 Years

Maximum age28 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	More than fortnightly use of an illicit drug in the last 28 days (other than cannabis).
•	Dependence on a substance other than cannabis and tobacco. 
•	Acute suicidal behaviour. 
•	Evidence of severe medical condition (including, severe hepatic (LFTs more than 5 times normal) and/or renal impairment (estimated GFR <60) or cardiovascular disease (hx of congential heart disease), or cognitive impairment (documented evidence of neuropsychological impairment)).
•	People with current prescriptions (within past month) for antipsychotic medications  or tricyclic antidepressants. 
•	Known or suspected allergy to cannabinoids, propylene glycol, ethanol, peppermint oil, corn oil or gelatine.
•	Females who are pregnant, lactating, or not using adequate contraception.
•	Males who are not using adequate contraception.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital Melbourne
Primary Sponsor Address: 55 Victoria Parade Fitzroy Vic 3065
Primary Sponsor Country: Australia

Trial IDACTRN12616001001482

Contact person for information and recruitmentMs
Amanda Norman
Department of Addiction Medicine St Vincent's Hospital Melbourne 55 Victoria Parade Fitzroy Victoria 3065
+61 3 92316947

Further information iconamanda.norman@svha.org.au
Australia

Medicinal Cannabis for Anorexia in Advanced Cancer

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate whether a vaporised form of medicinal cannabis is feasible and effective in increasing appetite in cancer patients with anorexia. 
Who is it for? You may be eligible for this trial if you are aged 18 or over, have an advanced cancer and have been suffering from anorexia for at least two weeks. 
Study details: Participants will receive a range of doses of vaporised botanical cannabis flower bud one hour before your meals (three times a day) for 7 days unless side effects occur. Each dose may be different from the previous dose, but they will all be made up to the same weight of plant material by adding different amounts of inactive plant material (‘placebo’, which has the same characteristics of leaf cannabis with the active components removed).   Participants will have blood samples taken at multiple timepoints up to 4 hours following each morning dose and will complete a number of questionnaires and a daily food record to determine the concentration of the drug in the blood, and to monitor its effect on appetite, mood and other factors. 
It is hoped that the findings from this trial will provide information on whether inhalation of medicinal cannabis is feasible for achieving a safe and effective blood concentration for the treatment of anorexia in cancer patients.

Broad Health ConditionCancer
Anorexia

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Sacred Heart Hospice - Darlinghurst

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment25/07/2016

Anticipated date of last participant enrolment31/12/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1) Age 18 years or above;
2) Advanced cancer; 
3) Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score less than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions
4) English-speaking (or have an interpreter available);
5) Performance status (Australia-modified Karnofsky Scale score) of 40 or above;
6) Written informed consent.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1) Hepatic impairment (Child’s Stage B)
2) Renal impairment (estimated glomerular filtration rate of <10 mL/min)
3) Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26); 
4) Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation); 
5) Acute delirium or delirium within < 30 days; 
6) Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure); 
7) Impaired pulmonary function which prohibits use of vaporiser; 
8) Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids; 
9) Pregnant, breastfeeding or unwillingness to use oral contraceptives; 
10) Substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco). 
11) Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility).
12) Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the criteria for therapies allowed at eligibility assessment 
13) Participation in a clinical trial of another chemical entity.
14) Conditions causing irreversible or blood transfusion dependent anaemia where the volume of blood sampling required for this study is contraindicated in the opinion of the treating clinician.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of New South Wales
Primary Sponsor Address: Anzac Parade, Kensington NSW 2052
Primary Sponsor Country: Australia

Trial IDACTRN12616000516482

Contact person for information and recruitmentProf
Meera Agar
Ingham Institute of Applied Medical Research 1 Campbell Street, Liverpool NSW 2170
+61 0295144232
+61-2-8738 9149
Further information iconmeera.agar@sswahs.nsw.gov.au
Australia

The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence

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Trial Information

Trial summary

The study will explore the psychophysiological and neurobiological and mechanisms of CBD in
participants with alcohol use disorder

Broad Health ConditionAlcohol Withdrawal
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

Specific Health ConditionAlcohol Use Disorder (AUD)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Hospital
Drug Health Services, Royal Prince Alfred Hospital

Anticipated date of first participant enrolment1/06/2022

Phase of TrialPhase 2

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Male and female patients between ages of 18 and 65 meeting DSM-5 criteria for current
       alcohol use disorder

    -  Adequate cognition and English language skills to give valid consent and complete
       research interviews;

    -  A BrAC reading of 0.00

    -  Must have a stable residence and be able to identify an individual who could locate
       subject if needed

    -  Provision of informed consent

  Exclusion Criteria:

    -  Active major psychological disorder associated with psychosis, significant suicide
       risk

    -  Pregnancy or lactation - women shall be advised to use reliable contraception for the
       duration of drug therapy and a urine pregnancy test will be performed where necessary;

    -  Dependence on any substance other than nicotine (eg methadone)

    -  Diagnosis of epilepsy, and/or current use of anti-epileptic drugs (AED)

    -  Liver failure with jaundice or prolonged INR above 1.3

    -  Medical complications such as liver failure, cardiac ischemia or conduction
       abnormalities, renal impairment or unstable elevated vital signs (systolic blood
       pressure > 180, diastolic blood pressure > 120 or heart rate > 150)

    -  Severe cognitive impairment or insufficient English or literacy to complete study
       processes

    -  Concurrent use of drugs potentially exacerbated by CBD via CYP3A5 including cardiac
       medication (e.g. betablockers, calcium channel blockers and statins), macrolides and
       recent antihistamine use.

    -  Claustrophobia;

    -  Extreme obesity;

    -  Previous brain surgery;

    -  Ever employed as a machinist, a welder or a metal worker;

    -  Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants;
       metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing
       aid or a prosthetic device.

Minimum age18 Years

Maximum age65 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: South West Sydney Local Health District

Trial websitehttps://clinicaltrials.gov/show/NCT05387148

Trial IDNCT05387148








A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults

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Trial Information

Trial summary

A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics
of PUR3100 in Healthy Adults

Broad Health Condition

Specific Health ConditionHealthy

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC,

Phase of TrialPhase 1

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Male or female subjects aged 18 to 55 years of age with a body mass index =17 and =35
       kg/m2.

    2. Subject has normal screening and baseline blood pressure, defined as a systolic value
       =90 mmHg and =140 mmHg and a diastolic value >60 mmHg and <90 mmHg.

    3. Female subjects who are of childbearing potential and male subjects with female
       partner(s) of childbearing potential must agree to use an effective contraceptive
       throughout the study (e.g., oral contraceptives or Norplant®; a reliable double
       barrier method of birth control [diaphragms with contraceptive jelly; cervical caps
       with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices;
       partner with vasectomy; or abstinence) and for at least 90 days after study drug
       administration. In addition, female subjects must have a negative serum pregnancy test
       at screening and a negative urine pregnancy test prior to dosing. Note: Women of
       non-childbearing potential may be enrolled if they are:

         1. Surgically sterile (e.g., hysterectomy with or without oophorectomy; fallopian
            tube ligation; endometrial ablation), for at least 30 days prior to signing the
            ICF

         2. Post-menopausal (= 12 consecutive months of spontaneous amenorrhea and > 50 years
            of age)

    4. Female subjects must agree not to donate ova/oocytes during the study and for 90 days
       after the last dose of IMP.

    5. Male subject must agree not to donate semen during the study and for 90 days after the
       last dose of IMP.

    6. Subject is able and willing to abstain from alcohol for 48 hours prior to admission to
       the study unit and throughout the entire study until completion of the Day 7 follow up
       visit.

    7. Subject is willing to participate in the study, comply with the study requirements,
       and voluntarily provide written informed consent.

    8. Subject can read, write, and speak English.

    9. Subject is mentally competent to provide informed consent.

   10. Subject can perform technically acceptable spirometry at screening.

   11. Subject can demonstrate the correct inhalation technique for use of the delivery
       device and to generate sufficient peak inspiratory flow (PIF) of at least 40 L/min
       using the In-Check DIAL device at screening.

  Exclusion Criteria:

    1. Subject has a history of proven or suspected coronary artery disease (CAD), coronary
       vasospasm (including Prinzmetal's angina), peripheral vascular disease, or other
       ischemic diseases (e.g., ischemic bowel syndrome or Raynaud's syndrome) or cardiac
       disorder (e.g., any clinically significant dysrhythmia), any history of heart attack
       or stroke, hypertension, diabetes mellitus, liver or kidney disease, aortic aneurysm,
       chronic pulmonary disease, or recent (within 3 months) sepsis or vascular surgery.

    2. Subject has a current diagnosis of asthma, chronic obstructive pulmonary disease,
       active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
       interstitial lung disease, known alpha-1 antitrypsin deficiency, or other active
       pulmonary disease.

    3. Subject has clinically significant abnormal laboratory values at screening that, in
       the opinion of the investigator would make the subject inappropriate for the study or
       put the subject at undue risk, specifically liver function tests (LFTs) >1.5 times the
       upper limit of normal (ULN); hemoglobin <10 gm/dL; absolute neutrophil count (ANC)
       <2.0 x 109/L; white blood cells (WBC) ?11 x 109/L; platelets <100,000 or >500,000;
       international normalization ratio (INR) >1.3.

    4. Subject has a QTcF of >450 msec in males or >470 msec in females at screening.

    5. Subject has forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC)
       on screening spirometry that is less than 80% predicted.

    6. Subject has a history of illicit drug or alcohol abuse within the past 12 months prior
       to screening.

    7. Subject smokes more than 5 cigarettes per day or vapes more than 5 times per day with
       devices that deliver nicotine.

    8. Subject has a history of nicotine replacement products daily within 6 months prior to
       screening.

    9. Subject has a positive alcohol test result at screening.

   10. Subject has a positive urine drug test result at screening, unless the result can be
       explained by the subject's current medications, in which case the PI should discuss
       the disposition of the subject with the Sponsor. Cannabidiol (CDB) and tetrahydro
       cannabinol (THC) use is prohibited.

   11. Subject has a known sensitivity to the study drug or any of the excipients of the
       formulation, or history of clinically significant sensitivity to any agent that, in
       the opinion of the investigator, would make participation in the study inadvisable.

   12. Subject has donated blood or blood products or had substantial loss of blood (more
       than 500 mL) within 6 weeks prior to screening.

   13. Subject has participated in an interventional study involving an experimental
       therapeutic agent within 3 months of screening.

   14. Women who have a positive serum ß-human chorionic gonadotropin (hCG) pregnancy test at
       screening or a positive urinary hCG pregnancy test prior to dosing, is pregnant,
       lactating, or planning to become pregnant during the study or within 90 days after
       conclusion of study participation.

   15. Subject has a positive hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV)
       antibody or human immunodeficiency virus (HIV) test result. Subjects who are hepatitis
       B surface (HBs) antibody positive or hepatitis B (HB) core antibody positive are not
       excluded provided the HBsAg result is negative. Subjects who are HCV antibody positive
       are not excluded if a subsequent HCV RNA test is negative.

   16. Subject has a planned surgery or procedure during participation in the study and for
       28 days after the conclusion of study participation.

   17. Subject is an employee of the investigator or study site with direct involvement in
       the proposed study or other studies under the direction of that investigator or study
       site or is a family member of a study site employee or the investigator.

   18. Subject has a current or chronic history of liver disease or known hepatic or biliary
       abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).

   19. The subject is unable or unwilling to comply fully with the study protocol.

   20. Subject is mentally or legally incapacitated.

   21. Subject is unable or unwilling to undergo multiple venepuncture procedures or the
       subject has poor access to veins suitable for cannulation.

   22. There is a condition or situation that, in the opinion of the investigator, would make
       participation in the study inadvisable.

   23. Subject has a history of chronic uncontrolled disease including, but not limited to,
       cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal,
       hematologic, urologic, immunologic, or ophthalmic diseases that, in the opinion of the
       investigator, would make participation in the study inadvisable.

   24. Subject has had major surgery within 6 weeks prior to screening.

   25. Subject has a disclosed history, or one known to the investigator, of significant
       noncompliance in previous investigational studies or with prescribed medications.

   26. Subject requires supplemental oxygen, even on an occasional basis.

   27. Subject received a live vaccine within 14 days prior to screening.

   28. Caffeine-containing beverage e.g coffee, tea, or caffeine sodas or power drinks
       (greater than 3 cups per day, 1 cup=250 mL) within 3 months prior to screening.
       Subject is UN able and unwilling to abstain from tea, coffee, or caffeine-containing
       beverages for 48 hours prior to admission to the study unit and throughout the entire
       study until completion of the Day 7 follow up visit.

Minimum age18 Years

Maximum age55 Years

GenderAll

Can Healthy volunteers participate?Accepts Healthy Volunteers

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Pulmatrix Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT05351086

Trial IDNCT05351086








The CANabidiol Use for RElief of Short Term Insomnia

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Trial Information

Trial summary

This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus
a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia
symptoms.

Broad Health ConditionInsomnia
sleep
fatigue
cannabidiol
CBD
mental health
anxiety

Specific Health ConditionSleep Disturbance
Insomnia
Insomnia Type; Sleep Disorder
Insomnia, Transient
Insomnia Due to Anxiety and Fear
Insomnia Due to Other Mental Disorder

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Phase of TrialPhase 2

Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Male and females aged 18-65 years old, inclusive.

    2. Females must be non-pregnant, non-lactating.

    3. Proficient in English and have internet access and a mobile phone.

    4. Insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8 - 21
       and have experienced these symptoms over the past month at pre-screening.

    5. Stated willingness to comply with all study procedures and availability for the
       duration of the study.

    6. Provision of signed and dated informed consent form.

    7. All male and females of childbearing potential must agree to use two forms of
       effective contraception from the time of signing informed consent until 30 days after
       study completion.

  Exclusion Criteria:

    1. Serious medical and/or psychiatric illnesses/disorders that will require treatment
       during the trial period.

    2. The use of any drug known to affect sleep during the study one week prior the
       randomization, including:

         1. Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate,
            sedating antidepressants, sedating antihistamines, antipsychotics, melatonin,
            valerian).

         2. Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl,
            tramadol, tapentadol, hydromorphone).

         3. Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).

    3. Excessive caffeine use (defined as > 600mg caffeine or approximately 6 cups of
       caffeinated beverages a day) that, in the opinion of the medical doctor, contributes
       to the participant's insomnia.

    4. Excessive alcohol use (defined as per NHMRC guideline, i.e. no more than four standard
       drinks per day on average for men, and for women, no more than two).

    5. The use of cannabinoids or a cannabinoid-based medicine within 3 months prior to study
       Day 1 and unwillingness to abstain from recreational drug use during the study period.

    6. Cannabis dependence or any other drug or alcohol dependence within the past two years.

    7. Positive urine drug screen (e.g., amphetamines type substances, benzodiazepines,
       cannabinoids, cocaine, and opiates) at screening or Day -1 or a history of drug abuse
       within the past 2 years.

    8. Known hypersensitivity to cannabis-based products or any of the excipients in the
       study drug.

    9. Use of any investigational drug or involvement in another clinical trial within 30
       days of screening day.

   10. Use of anti-coagulant drugs such as warfarin or those known to be metabolised by
       CYP450 enzymes.

   11. Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT)
       and CNS-active drugs).

   12. Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported
       sleep disorders.

   13. Medical conditions that result in frequent sleep disturbance (e.g. nocturia).

   14. History of attempted suicide in the past 12 months.

   15. Clinically significant hepatic abnormalities determined by the screening blood test.

   16. Shift work, jet lag or trans-meridian travel (two time zones) in the past month.

Minimum age18 Years

Maximum age65 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Bod Australia

Trial websitehttps://clinicaltrials.gov/show/NCT05253417

Trial IDNCT05253417