Search results from the Australian New Zealand Clinical Trials Registry

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Keyword: cannabinoid
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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 statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Hospital
Wollongong Hospital - Wollongong

Postcode
2500 - Wollongong

Anticipated date of first participant enrolment10/01/2022

Anticipated date of last participant enrolment12/09/2022

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 12 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 age75 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, kidney or heart function;
4.	Active suicidal ideation;
5.	Intake of CBD, THC or cannabis within one month prior to study inclusion;
6.	Prior extensive use of CBD, defined as use greater than weekly for more than 3 months in the two years prior to study inclusion;
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;
8.	Prior history of treatment for alcohol use disorder, or a current score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT);
9.	Any current or recent diagnoses, or a clinically relevant history, of insulin dysregulation (e.g. diabetes, insulin resistance) or cholesterol (e.g. atherosclerosis) disorders;
10.	Any current or recent diagnoses of neurological disorders other than dementia, including epilepsy or Parkinson’s disease;
11.	Medications that may interact with CBD, including 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);
12.	Taking medications that may affect cognitive function (e.g. anticholinesterase inhibitors, memantine or psychoactive medications).
a.	If a participant needs to start taking a medication on the exclusion criteria list for their health during the study, their participation in the trial will be stopped.
13.	Participation in any other clinical drug trials within 30 days of the current study;
14.	Anticipated surgical needs within 3 months of the study commencing.
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 Mills
School of Psychology, Building 41, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500.
+61 2 4221 3732

Further information iconjmills@uow.edu.au
Australia

The effect of soccer heading on the brain.

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Trial Information

Trial summary

This study is a randomised, controlled, crossover, non-pharmacological, unblinded pilot trial. Participants will complete two experimental trials during which they will perform either a soccer heading or control kicking task. Brain structure, function and chemistry will be assessed ~30-minutes later using advanced neuroimaging techniques. Individuals will also provide blood samples and complete cognitive function tests at regular intervals post-intervention. Trials will be conducted at Neuroscience Research Australia (NeuRA), Randwick, NSW. We hypothesise that reduced efficiency of brain function and neural viability will be detected relative to the control condition. 

Broad Health ConditionSubconcussive Head Impacts

Specific Health ConditionInjuries and Accidents
Other injuries and accidents

Trial FocusDiagnosis

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment1/11/2021

Anticipated date of last participant enrolment1/05/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Healthy individuals
- More than or equal to 5 years of soccer heading experience; that is, more than or equal to 5 full seasons of play and(or) training (with heading) the most recent of which was completed in the last 2 years.
- Proficient in English and able to provide informed consent

Minimum age18 Years

Maximum age35 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

(a)	A self-reported head, neck, face and/or eye injury (including concussion; as assessed via the Concussion History Questionnaire in the last 12 months
(b)	A current, self-reported sports injury (any type)  
(c)	A self-reported history of neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness >15-minutes, spinal cord injury, stroke)
(d)	Implantation of a cochlear device, cardiac pacemaker, intracardiac lines, medical fusion device, neurostimulator or metal plates (in the head) 
(e)	Use of dental braces or eyeglasses (contact lenses permitted) 
(f)	A contraindication to MRI (that is not already excluded in another criterion) (i.e., body and(or) facial piercings that cannot easily be removed, a drug infusion pump that cannot easily be removed) 
(g)	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] 
(h)	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
(i)	Inability to avoid soccer heading or any other activity involving head impacts (e.g., contact sports) 7-days prior to and while participating in this project  
(j)	Inability to refrain from consuming alcohol (24 hours) and caffeine (12 hours) prior to each experimental trial 
(k)	Inability to refrain from using anti-inflammatory medications (4-days) prior to each experimental trial (e.g., non-steroidal anti-inflammatories [NSAIDs], such as Ibuprofen, Naproxen, Diclofenac; and corticosteroids, such as Prednisolone). 
(l)	Inability to refrain from using central nervous system (CNS) active drugs (i.e., cocaine, cannabis, amphetamines, methamphetamine, benzodiazepines, methadone, opioids, oxycodone, barbiturates) 7-days prior to and while participating in this project as confirmed by a negative urine drug screen (UDS) (DrugCheck® NxStep Onsite Urine Test Cup)  
(m)	Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a urine pregnancy test (Human Chorionic Gonadotrophin [hCG] Cassette, AlereTM). Females of childbearing potential must also agree to use a reliable form of contraception while participating in this project. 
(n)	Current use of platelet active agents such as aspirin, ticagrelor, clopidogrel and prasugrel, warfarin and direct oral anticoagulants (DOACs)  
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 IDACTRN12621001355864

UTNU1111-1268-7034

Contact person for information and recruitmentMr
Nathan Delang
Brain and Mind Centre, Level 6 M02F, Rm 611, 94 Mallett St, Camperdown, NSW, 2050
+61402716729

Further information iconn.delang@griffith.edu.au
Australia

NanaBis™ an Oro-Buccal Administered delta9-Tetrahydrocannabinol (d9-THC) and Cannabidiol (CBD) Medicine For The Management of Chronic Pain From Metastatic Bone Cancer

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Trial Information

Trial summary

The purpose of this study is to determine whether a nanoparticle cannabis-based medicine (NanaBis™) is effective in reducing metastatic bone pain in patients with cancer.

Who is it for?
You may be eligible for this study if you are aged between 18-75 years old, have been diagnosed with any cancer that has metastasised to bone, and are experiencing bone pain.

Study details
Participants will be randomised using a computer software program to receive either the NanaBis™ spray and placebo oxycodone tablets for breakthrough pain, a placebo spray and oxycodone tablets or a placebo spray and placebo tablets. Participants will self-administer the spray into their mouth up to 2-7 times every 4 hours unless asleep, and the tablet up to twice per day as needed. All participants will answer a number of questionnaires before the study starts and throughout the study. These questionnaires are answered weekly during the visits to the study site, except for the Numerical Pain Rating Scale which is completed twice daily as part of the participants medication diary. All questionnaires are also completed at the end of the 6-week period. Participants will also have the option to continue the treatment for a further 12 weeks after the study is complete.

It is hoped that this study may demonstrate that NanaBis™ is safe, tolerable, and effective at reducing metastatic bone pain in patients with cancer.

Broad Health ConditionCancer
Bone Metastases
Pain Management

Specific Health ConditionCancer
Bone
Anaesthesiology
Pain management

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,QLD

Hospital
Mater Mother's Hospital - South Brisbane

Hospital
GenesisCare St Leonards - St Leonards

Postcode
4101 - South Brisbane

Postcode
2065 - St Leonards

Trial location outside Australia

Country
United States of America

Country
United Kingdom

Anticipated date of first participant enrolment1/10/2021

Anticipated date of last participant enrolment1/12/2023

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

At Screening Phase participants must fulfill all of the following criteria:
i.	Prospective male and female participants that are
     a.	in the age range 18 to 65 years or 
     b.	65 to 75 years without significant co-morbidities (heart, lung, liver or renal failure, myocardial infarction, cerebral vascular accident, peripheral vascular disease, chronic obstructive pulmonary disease, dementia, connective tissue disease or diabetes mellitus with end-organ damage)
ii.	Metastatic bone pain from a cancer diagnosis is the only major cause of pain. 
iii.	Pathology (imaging) confirmed metastatic bone cancer;
iv.	Meet International Classification of Diseases, Tenth Revision (ICD-10) codes for pain management criteria (i.e., bone cancer pain); 
v.	During the screening period, the participant is on stable opioid pain management and pain severity (NPRS) is less than or equal to 8 with a maximum variation of plus or minus 1. 
vi.	Pain Detect score is greater than 18
vii.	Participant willing and able to provide informed consent and follow study procedures
      a.	including agreeing to not drive or operate heavy machinery; and 
      b.	females of child-bearing potential agree to use reliable contraception during the duration of the clinical trial;
viii.	Patient deemed tolerable to Oxycodone and NanaBis™ determined by medical history of allergies to cannabinoids or opioids 

Minimum age18 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

i.	History of epilepsy or recurrent seizures;
ii.	Moderate to severe medical conditions such as
a.	Severe hepatic, cardiovascular, pulmonary or renal impairment; or 
b.	Psychiatric disorders (i.e., unstable schizophrenia, recent drug-induced psychosis, severe mood disorders), that would be assessed at the medical screen; 
iii.	If patients have been diagnosed with a substance abuse disorder. 
iv.	Women who are pregnant, lactating or planning to become pregnant; 
v.	Identified concerns by the nursing / medical team relevant to the safe storage of medications (i.e., NanaBis™ or standard medical therapy); 
vi.	Participants who may not be available for follow up (i.e., planned or expected travel or other);
vii.	Participants plan to undergo any treatment that will substantially reduce the burden of disease (and therefore bone pain) during the screening, titration or maintenance phase of the clinical trial such as radiotherapy or cytotoxic chemotherapy;
viii.	Participants who are unable to withhold all analgesia (apart from that which is part of this trial) during the titration and maintenance phase of the study, including bisphosphonates. Medications such as bisphosphonates may be coordinated so they are given either side of the excluded period that covers the titration and maintenance phases
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Medlab Clinical Ltd
Primary Sponsor Address: Unit 5-6/11 Lord Street Botany, NSW Australia 2019
Primary Sponsor Country: Australia

Trial IDACTRN12621001302842

Contact person for information and recruitmentMrs
Larah Hall
Medlab Clinical Ltd. Unit 5-6/11 Lord St, Botany, NSW Australia 2019
+61 02 8188 0311

Further information iconlarah_hall@medlab.co
Australia

A Phase IIb Double-Blind, Randomised Placebo-Controlled Clinical Trial to evaluate the efficacy and safety of a botanical cannabidiol (CBD) for sleep disturbances in a healthy population.

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Trial Information

Trial summary

The purpose of this trial is to assess the efficacy of cannabidiol (98% CBD) for sleep disturbances in healthy adults. This study will compare the botanical CBD with a placebo and evaluate its efficacy via the PROMIS sleep disturbance instrument. The study will take place in 4 sites; Brisbane, Sydney, Lismore and Melbourne. In total, the study will successfully enrol 438 participants. Eligible participants will be between 18 to 65 years old, considered to be generally healthy and self-reports sleep difficulty and quality. The trial will be 10 weeks, with an initial two-week titration period and a phone call one month after stopping medication. 
The study will involve a 15mg CBD per soft gelatin capsule or placebo capsule that is similar in appearance, smell and taste. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulted into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Participants will take 1 capsule after breakfast and 1 capsule 30 minutes before bed and build up to a tolerance/ maximum dose during the titration period with the maximum morning dose being 2 capsules and the maximum night dose being 8 capsules. After the titration period, the participants will stay on their maximum dose for 8 weeks or until they withdraw from the study. In total, the study should be 10 weeks in total with a one month follow up phone call after the ceasing the medication. 
The expected outcome is that a botanical CBD (98%) will significantly improve people's sleep who suffer from sleep disturbance more than the placebo.  

Broad Health ConditionSleep Disturbances
Anxiety
chronic pain
Fatigue

Specific Health ConditionAlternative and Complementary Medicine
Herbal remedies
Mental Health
Anxiety
Mental Health
Other mental health disorders
Neurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Postcode
2480 - Lismore

Postcode
4000 - Brisbane

Postcode
2000 - Sydney

Postcode
3000 - Melbourne

Postcode
4103 - Annerley

Postcode
4217 - Gold Coast

Postcode
2478 - Ballina

Anticipated date of first participant enrolment28/06/2021

Anticipated date of last participant enrolment5/05/2022

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Adults aged between 18 and 65 years old.
2. Considered to be generally healthy. 
3. A self-reported complaint of poor sleep quality that includes one or more of the following:
-Difficulty initiating sleep 
-Difficulty maintaining sleep 
-Waking up earlier than desired
4. Self-reports sleep difficulty occurring three nights a week or more for three months. 

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Pregnant or breast-feeding women
2.	Anyone with an acute disease
3.	Insomnia and severe sleep disturbances
4.	Diagnosed anxiety condition
5.	History of an unmanaged chronic disease
6.	Severe mental illness or difficulty communicating
7.	Recreational drug use (tested positive for THC at baseline)
8.	Alcohol intake higher than 14 units per week
9.	Smokes more than 2 nicotine cigarettes daily
10.	Works regular shift work
11.	Travels across more than 2 time zones in the last two weeks.
12.	Consumes more than 300mg/day of caffeine
13.	People with elevated liver enzymes or liver damage
14.	People who have had a cardiac arrest or severe cardiovascular disease
15.	People with chronic kidney disease
16.	Current steroid administration
17.	Current chemotherapy, radiation, immune suppressant therapy, immunotherapy or similar medical treatments.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Southern Cross University
Primary Sponsor Address: 1 Military Road, East Lismore NSW 2480 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12621000632897

Contact person for information and recruitmentDr
Janet Schloss
National Centre for Naturopathic Medicine Southern Cross University 1 Military Road, Lismore NSW 2480
+61 0436 101 306

Further information iconNCNMtrials@scu.edu.au
Australia

Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) effects on perception of illusions, schizotypy and cognition in healthy volunteers

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Trial Information

Trial summary

The hypothesis is that there are certain types of what are called schizotypy (schizophrenic-like) states or traits that can predict how a person may respond to THC and/or CBD: in a pro- or anti-psychotic manner, to guide potential medicinal use of cannabis in psychiatry.  The aim s to compare THC (the psychoactive component in cannabis) with CBD ("non-psychoactive" component in cannabis) on its effects on the multi-sensory perceptions in the healthy volunteers. We have previously shown that certain drugs can produce effects on the perception of illusions that are similar to differences in the perceptions of those illusions by people suffering from schizophrenia. Determining the effect of the cannabinoids on these differences in perceptions in healthy people, and the relationship of those effects with the effect on mild schizophrenic similar states and traits may allow us to determine which people will find THC or CBD to be medicinally helpful, and those that should avoid these drugs.

Broad Health ConditionSchizophrenia
Psychosis
Cannabis use safety

Specific Health ConditionMental Health
Schizophrenia
Mental Health
Psychosis and personality disorders
Mental Health
Studies of normal psychology, cognitive function and behaviour

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
WA

Postcode
6009 - Nedlands

Postcode
6009 - Crawley

Postcode
6009 - Broadway Nedlands

Anticipated date of first participant enrolment3/05/2021

Anticipated date of last participant enrolment22/12/2023

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Inclusion Criteria:
1. They are between 18 and 59 years of age.
2. They are healthy (have no ongoing medical, including psychiatric, condition, other than acne.

Minimum age18 Years

Maximum age59 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Exclusion Criteria: 
1.  Any current medical (including psychiatric) condition other than acne.
2. Women that are pregnant or breast-feeding.
3.   Women that fertile, sexually active, and not using a contraceptive.
4.   Using current prescription medications other than contraceptives or acne medications.
5.  A family history of a psychotic illness (E.g., schizophrenia or bipolar disorder) in their first-degree relatives.
6.  Use of any drugs other than contraceptives or acne medications 48 hours before the testing days. These include prescription medications, over-the-counter medications or “naturopathy” medications such as St John’s Wort (that can interfere with drug metabolism), but do not include nicotine if the person is nicotine-dependent as withdrawal from nicotine produces an unusual physiological state.
7. History of a major brain or head injury.
8. Need for a hearing aid.
9. Poor eyesight when wearing glasses.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Western Australia
Primary Sponsor Address: 35 Stirling Highway, Crawley, WA 6009
Primary Sponsor Country: Australia

Trial IDACTRN12621000469819

UTNU1111-1262-6903

Contact person for information and recruitmentProf
Mathew Martin-Iverson
Pharmacology, School of Biomedical Sciences, University of Western Australia, Room 1.42B, M Block, Queen Elizabeth II Medical Centre, Nedlands, WA 6009
+61 8 6457 2982

Further information iconmathew.martin-iverson@uwa.edu.au
Australia

Observational Study of two low dose medicinal cannabis oral oils to treat Autism associated behaviours.

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Trial Information

Trial summary

This is an open label, observational study enrolling people (including children and adolescents (from 6 to 18 years) and adults) with ASD presenting with behavioural symptoms (including behaviour (aggressiveness, hyperactivity, irritability), social and emotional responsiveness, and communication skills) that receive medicinal cannabis as prescribed per standard practice. Patients will receive medicinal cannabis products HOPE 1 and/or HOPE 2 as per standard of care recommendations by their treating doctors. Patients will be assessed for their disease and safety according to standard practice. Each patient will be observed for a period of six months from the first visit. 

Observation will only be on those patients that have been prescribed HOPE 1 and/or HOPE 2. 

Broad Health ConditionAutism Spectrum Disorder (ASD)

Specific Health ConditionMental Health
Autistic spectrum disorders

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,WA,VIC

Hospital
Emerald Clinics Ltd - West Leederville - West Leederville

Postcode
6007 - West Leederville

Anticipated date of first participant enrolment15/04/2021

Anticipated date of last participant enrolment31/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

a.	Signed consent (patients and/or carer)
b.	Have a documented history of Autism Spectrum Disorder (including diagnosis and severity of ASD)
c.	Patient and caregiver must be able to return to clinic on days specified in the protocol
d.	Patient and caregiver must be able to adhere to all assessments as described
e.	Have a valid assessment of severity using the Connors Parent and School assessment or similar tool within the previous 12 months 
f.	Have exhausted conventional therapies listed on the ARTG for ASD 
g.	For paediatric patients only: Have trialled or are being considered for treatment with antipsychotic medications 
h.	For paediatric patients only: Have a letter of support or referral from their treating paediatrician to trial cannabinoid therapies or be managed by Emerald Clinics.
i.	Planned to be administered either HOPETM 1 and/or HOPETM 2 medicinal cannabis

Minimum age6 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

j.	Patient is currently using recreational or medicinal cannabis, or synthetic cannabinoid-based medications within one month prior to study entry and is unwilling to abstain for the duration of the trial.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zelira Therapeutics Ltd
Primary Sponsor Address: Level 26, 140 St Georges Terrace Perth WA 6000
Primary Sponsor Country: Australia

Trial IDACTRN12621000370808

Contact person for information and recruitmentDr
Alistair Vickery
Emerald Clinics Ltd Suite 9, Level 1 2 McCourt St West Leederville WA 6007
+61 08 6559 2829

Further information iconinfo@emeraldclinics.com.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 statusNot yet recruiting

Recruitment Details
Recruitment State
QLD,SA,WA,VIC

Postcode
3052 - Parkville

Postcode
3020 - Sunshine

Postcode
3064 - Craigieburn

Postcode
3046 - Glenroy

Postcode
5000 - Adelaide

Postcode
4215 - Southport

Postcode
6056 - Midland

Postcode
6017 - Osborne Park

Postcode
6027 - Joondalup

Postcode
4068 - Taringa

Postcode
4020 - Redcliffe

Postcode
4500 - Strathpine

Postcode
6014 - Wembley

Anticipated date of first participant enrolment15/04/2021

Anticipated date of last participant enrolment15/04/2024

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Age 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 

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

A non-interventional study looking at safety and efficacy of medicinal cannabis prescribed to patients with symptoms of Irritable Bowel Syndrome (IBS).

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Trial Information

Trial summary

CALM-GUT study is an observational study that aims to evaluate cannabinoid based medicines as a potential therapy for reducing symptoms of irritable bowel syndrome (IBS).

Patients over 18 years of age who attend Emerald Clinics for treatment of IBS symptoms with cannabinoid based medicines will be offered participation in the study.  Patients are observed for 12 weeks, using a combination of validated questionnaires, self-reported symptoms, and regular follow up with a specialist GP or gastroenterologist.  

Baseline symptoms and responses to questionnaires will be compared to results after 12 weeks to determine if the treatment is safe and effective in this patient cohort.  

Broad Health ConditionIrritable Bowel Syndrome

Specific Health ConditionOral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,WA,VIC

Hospital
Emerald Clinics Ltd - West Leederville - West Leederville

Postcode
6007 - West Leederville

Anticipated date of first participant enrolment8/02/2021

Anticipated date of last participant enrolment13/08/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. > 18 years of age at the time of consent
2. Meets Rome IV criteria for IBS of any subtype [IBS with constipation (IBS-C), IBS with diarrhoea (IBS-D), mixed type IBS (IBS-M) or unsubtyped IBS(IBS-U)].
3. Abdominal pain should be present for at least 1 day per week for the last 3 months and the origin of the symptoms should be at least 6 months before. The symptoms should be related to at least two of the following:
a. Related to defecation
b. Associated with a change in stool frequency
c. Associated with a change in stool (appearance)
4. Able and willing to comply with all study procedures
5. Agrees to NOT drive for duration of study if taking medicinal cannabis products containing THC, in accordance with local laws
6. Treated with cannabinoid medicines at Emerald Clinics

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. History of Gastric, small bowel or colonic surgery
2. Diagnosis of Inflammatory Bowel Disease
3. Known Coeliac Disease
4. Diagnosis of cancer (not in remission)
5. Pregnant or Breastfeeding women
6. Severe Unstable mental illness (suicidal ideation, psychotic symptoms) based on self-report or depression scores on the DASS greater than or equal to 11 or anxiety scores on the DASS greater than or equal to 12
7. History of suicide attempt
8. History of schizophrenia
9. History of seizures or epilepsy
10. History of drug or alcohol abuse
11. Current cannabis use (within 2 weeks) prior to initial assessment visit.
12. Severe unstable heart disease (unstable angina or ischaemic heart disease, heart failure greater than NYHA Grade 2)
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Emyria Limited
Primary Sponsor Address: 43 Oxford Close West Leederville, WA 6007
Primary Sponsor Country: Australia

Trial IDACTRN12621000102875

UTNU1111-1261-7354

Contact person for information and recruitmentMs
Tracie Ernenwein
Emyria, Ltd. 43 Oxford Close, West Leederville, WA, 6007
+61 431544702

Further information iconternenwein@emyria.com
Australia

Double blind, randomised, placebo controlled trial of Sativex for the management of cannabis withdrawal

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Trial Information

Trial summary

The primary objective of the study is to examine the safety and efficacy of SATIVEX 'Registered Trademark (R)' in the inpatient management of cannabis withdrawal, in a double blinded randomised trial compared to placebo. Specifically, the study will compare withdrawal severity, detoxification completion and adverse events between the two conditions in an intention-to-treat analysis. Secondary objectives include 1-month post-withdrawal outcomes (including cannabis and other drug use and psychosocial outcomes), and to assess the relationship between the number, severity and duration of cannabis withdrawal symptoms and rates of continuous and point prevalence abstinence from cannabis, time to relapse, levels of cannabis use, and cannabis related problems at one month follow-up. The study will also explore the cognitive impact of withdrawing from cannabis, as well as the impact of SATIVEX on cognitive functioning, with an aim to assessing the real world safety profile of the drug ahead of larger outpatient studies. The study will also explore the pharmacokinetics and metabolites associated with SATIVEX (R) administration to develop a protocol for differentiating between SATIVEX(R) and illicit cannabis in blood or urine among those entering cannabis withdrawal treatment. This pharmacokinetic assay will prove useful for future large scale outpatient trials should the current trial prove successful. A final exploratory objective of the study is to determine whether there is evidence of an interaction with the efficacy of SATIVEX(R) and patient characteristics on admission (including demographics and cannabis and other use and psychosocial factors such as treatment expectancy) on reported severity of cannabis withdrawal and subsequent post-withdrawal outcomes (cannabis use, psychosocial outcomes, sleep disturbances and cannabis-related problems) to be fully tested in a larger community study.

Broad Health ConditionCannabis withdrawal

Specific Health ConditionPublic Health
Health service research
Mental Health
Addiction

Trial FocusTreatment

Recruitment statusNot yet recruiting


Postcode
2000

Postcode
2300

Anticipated date of first participant enrolment31/07/2011

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Between 18-65 years of age (Both males and females)
2. Regular recent cannabis use (average of 5 times per week – self report)
3. Meet DSM-IV-TR 'Registered Trademark' criteria for cannabis dependence
4. Has made unsuccessful quit attempts in the past                 		
5. Desire to give up cannabis
6. Prepared to enter a hospital ward for 9 days

If NO to any (1 - 6) client is not eligible for SATIVEX trial phone screen, provide usual referral/treatment advice.

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. More than twice weekly use of an illicit drug in the last 30 days (other than cannabis)
2. Dependence on a substance other than cannabis and tobacco
3. Pregnant or breastfeeding
4. Female of child bearing potential NOT using contraception
5. Evidence of severe medical impairment (e.g. chronic pain, severe hepatic impairment or cardiovascular disease)
6. Evidence of severe cognitive or psychiatric impairment (e.g. bipolar, schizophrenia, suicidal ideation)
7. Current (within past month) prescription for antipsychotic or mood stabilising medications   
8. Currently prescribed warfarin
9. Allergy to cannabinoids, propylene glycol, ethanol or peppermint oil
10. Not English literate
 11. Specialist substance use treatment in the last 30 days
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of New South Wales
Primary Sponsor Address: The University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Primary Sponsor Country: Australia

Trial IDACTRN12611000398909

UTNU1111-1120-7086

Contact person for information and recruitment
Professor Jan Copeland
National Cannabis Prevention and Information Centre, NDARC, UNSW, Sydney NSW, 2052, Australia
+61 2 9385 0208
+61 2 9385 0201
Further information iconj.copeland@unsw.edu.au
Australia

Hair drug analysis to identify cases of drug-facilitated sexual assault

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Trial Information

Trial summary

The purpose of this study is to compare hair drug analysis with urine and blood drug analysis which is currently used for investigating allegations of drug facilitated sexual assault (DFSA). Our hypothesis is that hair drug analysis will detect additional drugs than those detected in urine and blood samples.
In addition, we hope to document drugs involved in suspicions of DFSA in the South Australian population, identify which drugs may have improved detection with hair toxicology and document time frames for drug detection in different biological specimens.

Broad Health ConditionDrug facilitated sexual assault

Specific Health ConditionOther
Research that is not of generic health relevance and not applicable to specific health categories listed above

Trial FocusDiagnosis

Recruitment statusNot yet recruiting

Anticipated date of first participant enrolment1/06/2010

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Attending the Yarrow Place Rape and Sexual Assault Service
Alleged or concern of sexual assault
Participant belief or concern and/or clinical suspicion of drug facilitation

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

People who are bald.
People undergoing chemotherapy or radiotherapy involving the head.
Inability to attend follow-up visit
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Tanya Boast
Primary Sponsor Address: Lyell McEwin Health Service, Haydown Road, Elizabeth Vale, SA 5112
Primary Sponsor Country: Australia

Trial IDACTRN12610000365066

Contact person for information and recruitment
Dr Tanya Boast
Lyell McEwin Health Service, Haydown Road, Elizabeth Vale SA 5112
+61 8 8182 9279

Further information iconTanya.Boast@health.sa.gov.au
Australia

Atmo SmartPill Comparison in Gastroparetic and Slow Transit Constipation Patients

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Trial Information

Trial summary

This study will compare gastrointestinal transit time measured by the SmartPill and the Atmo
gas capsule in patients with gastrointestinal motility disorders. Both of these devices allow
gastrointestinal transit time to be measured, however the SmartPill senses pH changes whereas
the Atmo Capsule measures gas profiles. A total of 60 participants (30 diagnosed with
gastroparesis, 30 with slow transit constipation) will attend Macarthur Clinical School at
Western Sydney University after an overnight fast. Participants will consume a standardised
meal before ingesting the SmartPill and Atmo Capsule. Each participant will carry a data
receiver until passage of the capsules. Anatomical landmarks will be defined by pH changes
(SmartPill) or oxygen profiles (Atmo Capsule). Statistical analysis will be performed via
linear regression and degrees of agreement for measurements between the two devices. Primary
end-points will be the agreement between gastric emptying, small intestinal and colonic
transit times generated by the devices.

Broad Health Condition

Specific Health ConditionGastroparesis
Slow Transit

Trial FocusDiagnosis

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,

Anticipated date of first participant enrolment15/08/2021

Phase of TrialNot Applicable

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Diagnosed with gastroparesis (idiopathic or diabetic) for at least 12 weeks (based on
       scintigraphy results) and able to eat orally.

    -  Diagnosed with slow transit constipation for at least 12 weeks (exclusion of
       constipation caused by structural abnormalities with colonoscopy, and confirmation of
       slow transit by 'marker studies' such as scintigraphy, radiolabelled or opaque X-ray
       study). Participant would have at least 1 bowel motion per week (either assisted or
       unassisted by medication).

    -  No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes [hemoglobin
       A1c >10% within the past 6 months], electrolyte imbalance).

    -  An endoscopy or gastrointestinal barium series within the past 3 years showing no
       organic disease that is potentially causative of symptoms.

    -  Ability to stop medications that may alter gastric pH (such as proton pump inhibitors)
       for 3 days prior to and during study.

    -  Ability to stop medications that may alter gastrointestinal motility (GLP-1 angonists,
       anticholinergics, cannabinoids, metformin, antispasmodic, prokinetics) for 3 days
       prior to and during study.

    -  Ability to stop antibiotic, probiotic and, prebiotic supplements 7 days before prior
       to and during study.

    -  Ability to stop laxatives (docusate, lactulose, sorbitol, senna, bisacodyl),
       suppositories (glycerin), and enema 3 days prior to and during the study.

    -  Does not require a MRI scan during the duration of this study

  Exclusion Criteria:

    -  Previous abdominal and/or pelvic surgery

    -  History of diverticulitis, diverticular stricture, and other intestinal strictures

    -  Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)

    -  Pregnant or nursing

    -  Patients on long-acting glucagon-like peptide (GLP-1)

    -  Implantable devices (e.g. pacemaker, defibrillator) [continuous glucose monitors are
       permitted].

    -  History of bezoar formation

    -  Dysphagia to solid foods

    -  Gastric/jejunal feeding tubes

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: Atmo Biosciences Pty Ltd

Trial websitehttps://clinicaltrials.gov/show/NCT04977063

Trial IDNCT04977063