Trial summary

The study aims to assess the feasibility and effectiveness of guided self-help CPT (CPT-GSH) in a stepped care model in treating PTSD using a randomised controlled trial. It is hypothesized that those who have successful outcomes with CPT-GSH will improve PTSD (primary outcome) and depression symptoms and quality of life similar to that of standard CPT delivered via video call. The study will also assess other factors contributing to treatment outcomes in stepped-care condition (e.g. client's response to low-intensity versus high-intensity treatment approach). Stepped care is predicted to be a cost-effective treatment modality for participants because of minimal therapist input and sessions compared to a standard CPT.

Broad Health ConditionPosttraumatic stress disorder (PTSD)

Specific Health ConditionMental Health
Other mental health disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Anticipated date of first participant enrolment30/09/2022

Anticipated date of last participant enrolment30/08/2024

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Participants should be over 18 years of age, meet diagnostic criteria of full PTSD or subthreshold PTSD specified by the DSM-5. Participants will also need access to a computer or phone with data plan to access the study materials and video call for assessment and therapy sessions.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants who do not meet the subthreshold criteria (e.g., PCL score of below 24) are not eligible to participate. Individuals with high risk of harm including significant suicidality or ongoing abuse, substance dependence, unmanaged psychosis or bipolar disorder, and significant cognitive impairment will be excluded from the study on the basis that they should have sufficient level of functioning to participate in the study. Those engaged in concurrent and regular therapy for anxiety/trauma will also be ineligible. Those undertaking medication changes will need to undergo a one-month stabilisation period before pretreatment assessment.

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?Approved

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).

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?Approved

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.

Trial summary

Project Twenty21 Australia is an observational study which will follow patients prescribed medicinal cannabis who have been diagnosed with either chronic pain, anxiety, post-traumatic stress disorder or multiple sclerosis. They will be followed for up to 6 months. The purpose is to investigate whether medicinal cannabis products are efficacious in alleviating the symptoms associated with these conditions, and if they are safe and tolerable. 

Broad Health Conditionanxiety
chronic pain
post traumatic stress disorder
multiple sclerosis

Specific Health ConditionMental Health
Anxiety
Mental Health
Other mental health disorders
Musculoskeletal
Other muscular and skeletal disorders
Neurological
Multiple sclerosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC

Postcode
3182 - St Kilda

Postcode
4006 - Fortitude Valley

Postcode
4567 - Noosa Heads

Postcode
4551 - Caloundra

Postcode
4225 - Coolangatta

Postcode
4101 - West End

Postcode
3204 - Bentleigh

Anticipated date of last participant enrolment31/05/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1. Patients, females and males, aged 18 years and over with a diagnosis which falls under one of the following four study categories: chronic pain, anxiety, PTSD, and multiple sclerosis and who are prescribed medicinal cannabis as per standard clinical practice by a clinician at Releaf Clinics.
2. In the professional opinion of the treating clinician, the patient is eligible to be prescribed medicinal cannabis in Australia. 
3. Ability to fully understand the potential side effects associated with medicinal cannabis, and the fact that driving with any amount of THC in your system is an offence under Australian driving laws in all states and territories
4. Ability to fully understand the requirements of participation in the study.
5. Provide written informed consent to participate in the study and are willing to comply with the study procedures.
6. Agree to be prescribed medicinal cannabis products from the Project Formulary.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Patients currently using recreational cannabis (where use is chronic and more than three days per week for the past 2 months) or medicinal cannabis for medical reasons
2.	Evidence of clinically relevant haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic or psychiatric disorder which in the opinion of the medical practitioner should preclude them from participating in the study.
3.	Known allergy to medicinal cannabis, CBD or any of the components of the medicinal cannabis products in the Project Formulary.
4.	Pregnancy or active breast feeding. 
5.	Clinically significant abnormalities in baseline laboratory test results including liver function and kidney function: Creatinine > 1.5 times upper limit of normal; ALT, AST or ALP > 2 times upper limit of normal.  
6.	Taking warfarin or any other blood thinning medication (which may interact adversely with CBD).
7.	Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to inclusion.
8.	Unwilling or unable to provide written informed consent.

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?Approved

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

Trial summary

This is an open labeled pilot study of 10 participants that will be treated with medicinal cannabis (THC: CBD 10:15 oil) in reducing tics-related symptoms in adolescents aged 12 - 18 years with Tourette Syndrome. Eligible participants will receive THC:CBD 10:15 oil. This pilot study will assess the feasibility of conducting a large scale, study of the administration of MC (THC:CBD 10:15 oil) in adolescents with TS.  This pilot study will also assess the safety and tolerance of the administration of THC:CBD 10:15 oil in adolescents with TS. Clinician and parent symptom ratings will be compared across the conditions to explore for a signal of efficacy.  

Broad Health ConditionTourette Syndrome

Specific Health ConditionNeurological
Other neurological disorders
Mental Health
Other mental health disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Liverpool Hospital - Liverpool

Postcode
2170 - Liverpool

Anticipated date of first participant enrolment1/02/2022

Anticipated date of last participant enrolment15/12/2023

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

Males and females aged 12 – 18 years of age;
DSM-5 diagnosis of TS as assessed by the study clinician.  
TS severity defined as a score of 20 out of 50 or higher on the Total Tic Severity section of the YGTSS;
No changes in either medication or other interventions in the 4 weeks prior to enrolment, and intention to remain on the same dose for the duration of the study;
Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
Agrees not to drive for the duration of the study.

Minimum age12 Years

Maximum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Non-English speaking parents;
Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder; or a family history of psychosis;
Taking anti-epileptic medications which interact with medicinal cannabis (e.g. clobazam, topiramate, zonisamide);
Abnormal liver function tests defined as ALT > twice ULN;
Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening
Pregnant or intending to become pregnant during the study, or breastfeeding.
History of clinically significant suicidal thoughts in the prior 12 months.

Trial summary

The introduction of legal medical cannabis in Australia presents a unique challenge for the current roadside drug testing (RDT) approach which was designed to deter driving after illicit drug use and mitigate associated road safety risks. Having a legal prescription for a THC-containing medical cannabinoid product is not at present a valid legal defence against the charge of driving with a detectable concentration of a prescribed illicit drug, which means that medical cannabis patients are effectively prohibited from driving. Understanding the detectability of medical cannabis products using the Securetec DrugWipe® TWIN and investigating the driving-related effects of medical cannabis use, are important research priorities that can help to inform effective road safety policy and law enforcement strategy in this area.  

This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD.

Broad Health ConditionMedical cannabis use

Specific Health ConditionPublic Health
Other public health

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of last participant enrolment13/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

•	Aged 21 years or older
•	Have a full driver licence (current or expired/lapsed in past 12 months)
•	Patients who have been prescribed medicinal cannabis under the Special Access Scheme B (SAS-B) containing predominately THC or that is THC/CBD equivalent for a refractory condition including, but not limited to: 
o	Chronic pain conditions
o	Sleep disorders
o	Inflammatory conditions 
o	Gastrointestinal disorders
o	Movement disorders 
o	Respiratory conditions
•	Able to attend a 7-hour session without using medical cannabis more than once 

Minimum age21 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Patient is unable to provide written informed consent
•	Patient is pregnant or lactating
•	Patient has been previously enrolled in the study 
•	Patient is unable to abstain for illicit drug use for 7 days prior to testing

Trial summary

Patients referred to the chief investigator’s chronic pain management clinic where appropriate are treated with medicinal cannabis.  Many of these patients are already taking opioid drugs (morphine-like drugs), which seldom control their pain and in many cases are deleterious to their health.  This study will evaluate outcomes in a group taking both opioids and cannabinoids in comparison to a group taking opioids but not taking cannabinoids. 

Broad Health Conditionchronic non-cancer pain

Specific Health ConditionNeurological
Other neurological disorders
Musculoskeletal
Other muscular and skeletal disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Postcode
6151 - South Perth

Anticipated date of last participant enrolment31/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Chronic non-cancer patients referred to Perth Pain Management Centre or to Dr Michael Kent who were taking opioid medications at or after the commencement of the audit (November 2020).

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Cannabinoid exclusion - previous significant drug addiction, pregnancy, lactation, previous psychotic illness, age (under 18) and relative exclusions of heart and liver disease.

Trial summary

This is an open-label Phase II pilot study to investigate the safety and tolerability of two doses of ketamine in young people with stimulant use disorder, methamphetamine-type seeking treatment to reduce their methamphetamine use. The study treatments will be provided in addition to treatment-as-usual received by participants during their regular clinical care. All participants will be engaged with a GP or psychiatrist, either through headspace, Orygen, or in the community, and they will be offered referral into outpatient alcohol and other drug treatment at headspace or in the community. They will receive psychiatric and medical review by the study doctor during screening and at weeks 1 and 2. Participants will complete comprehensive screening and baseline testing. They will then undergo two ketamine administration sessions (subcutaneous; initial dose 0.75 mg/kg) separated by at least 7 days. Assessments will occur at baseline and weeks 2, 3, 4, and 6. 

Broad Health ConditionMethamphetamine use problems

Specific Health ConditionMental Health
Addiction

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment17/05/2021

Anticipated date of last participant enrolment30/12/2022

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

•	15-25 years old inclusive at consent; 
•	Current stimulant use disorder – methamphetamine type, moderate or severe, assessed using the Structured Clinical Interview for DSM-5; 
•	Current methamphetamine use, indicated by positive urine toxicology (qualitative) for methamphetamine use at either screening or baseline visits; 
•	Seeking treatment to reduce methamphetamine use; 
•	Engaged with a regular treating doctor (general practitioner or psychiatrist); 
•	Ability to comply with the study protocol, as determined by the CI; and 
•	Ability to provide informed consent (both adequate IQ and English fluency; 15 to 17 year olds will provide consent themselves, as will a parent/guardian).

Minimum age15 Years

Maximum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	History of psychosis or bipolar disorder (other than transient drug-related symptoms) assessed with the SCID-5;
•	Acute suicidality, based on clinical judgement by the study doctor or other qualified clinician, or severe depression (>15 on the Quick Inventory of Depressive Symptomatology); 
•	If female, pregnancy or current breastfeeding, or, if sexually active, no effective contraception;
•	Abnormal liver or thyroid function as indicated by clinically significant findings on blood tests; 
•	If prescribed antidepressants, the participant must have been on a stable dose for >2 weeks;
•	Current treatment with antipsychotic medication, mood stabiliser, or ADHD medication; 
•	Participation in another trial, which is likely to affect safety or data quality for this study, as determined by the CI;  
•	Any unstable medical or neurological condition, or medical contraindication to ketamine use, e.g. uncontrolled hypertension; 
•	Current or past DSM-5 diagnosis with ketamine use disorder, moderate or severe; and 
•	Current DSM-5 diagnosis with other substance use disorders, moderate or severe, except tobacco, caffeine, or cannabis. 

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?Approved

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  

Trial summary

Vaporised nicotine products (VNPs or electronic cigarettes) hold significant potential as both cessation aids and harm reduction support for people who smoke tobacco.  There is now good evidence of safety, and emerging evidence that VNPs assist cessation. More evidence of the safety and effectiveness of VNPs for populations (such as persons who use drugs) with high smoking prevalence rates and low quit rates is desperately needed. Further it is important to determine the efficacy of novel strategies compared to current best practice treatment, Nicotine Replacement Therapy (NRT). The aim of this  trial is to test the effectiveness of VNPs at increasing smoking cessation amongst opiate agonist treatment (OAT) clients receiving treatment at alcohol and other drug (AOD) services across NSW Local Health Districts/Networks (LHD/Ns), compared to current best practice treatment (NRT). Service users from six LHD/Ns across NSW will be recruited and randomised. 

Broad Health ConditionTobacco smoking

Specific Health ConditionPublic Health
Health service research
Mental Health
Addiction

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Drug and Alcohol Clinical Services, Hunter New England Local Health District - Newcastle

Hospital
The Langton Centre - Surry Hills

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Cumberland Hospital - Westmead

Hospital
Royal Prince Alfred Hospital - Camperdown

Hospital
Liverpool Hospital - Liverpool

Hospital
St George Hospital - Kogarah

Hospital
Campbelltown Hospital - Campbelltown

Hospital
Canterbury Hospital - Campsie

Postcode
2300 - Newcastle

Postcode
2010 - Surry Hills

Postcode
2010 - Darlinghurst

Postcode
2145 - Westmead

Postcode
2050 - Camperdown

Postcode
2170 - Liverpool

Postcode
2217 - Kogarah

Postcode
2560 - Campbelltown

Postcode
2194 - Campsie

Anticipated date of first participant enrolment15/02/2021

Anticipated date of last participant enrolment31/03/2023

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Inclusion Criteria
•	Provide written, informed consent to participate in the study. 
•	Aged 18 to 65 years
•	Be accessing opioid agonist treatment from a participating service 
•	Current daily tobacco smokers on self-report
•	Want to quit or cut down their tobacco smoking  
•	Be willing and able to comply with requirements of study (including having access to a phone)

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Currently breastfeeding or pregnant, or of childbearing potential and planning/trying to fall pregnant during the study period 
•	Current, severe medical disorder assessed by study medical officer (such as but not limited to, unstable cardiovascular/peripheral vascular disease, poorly controlled hypertension) 
•	Current, severe and unstable psychiatric disorder assessed by study medical officer (such as but not limited to, acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others)
•	Current enrollment in a clinical trial involving any investigational drug  
•	Regular use (more than one day per week) of VNP or e-Cigarette containing nicotine in the last 30 days
•	Not available for follow-up (e.g. likely imprisonment or transfer out of service to another service that is not a trial recruitment site)

Trial summary

Alcohol and other drug use is a leading cause of harm for Aboriginal and Torres Strait Islander youth. Despite resilience and a continuous strong connection to culture, the ongoing impacts of colonisation, disempowerment, and inequity have an intergenerational impact on the wellbeing of Aboriginal and Torres Strait Islander adolescents. This intergenerational impact contributes to average initiation of substance use two to six years earlier among Aboriginal and Torres Strait Islander compared to non-Indigenous adolescents. Prevention of youth alcohol and drug use has therefore been identified as a key priority for improving the wellbeing and addressing health inequities between Aboriginal and non-Indigenous Australians. Previous research has found that curriculum programs implemented in secondary school can effectively prevent uptake of these substances by young people, and have flow-on benefits for social and emotional wellbeing, physical health, school attendance, and educational attainment. However, there are currently no school-based drug prevention programs that are culturally-inclusive and effective for Aboriginal and/or Torres Strait Islander students. To address this gap we partnered over the past three years with Gilimbaa, an Indigenous Creative Agency, and four schools in QLD and NSW to develop Strong & Deadly Futures, a cultural adaptation of the effective Climate Schools school-based prevention program. The program was co-developed with school staff and Aboriginal and/or Torres Strait Islander youth, who shared their stories, role models, things they love about their community and positive reasons for not using alcohol and other drugs. These perspectives formed the basis of the story arc for an illustrated story, which communicates the key prevention messages and highlights Aboriginal and/or Torres Strait Islander cultural strengths. The current trial builds on a successful pilot study in four schools, and will be the first RCT of a school-based, culturally-inclusive drug and alcohol program for young Aboriginal and/or Torres Strait Islander peoples.

Strong & Deadly Futures will recruit 960 Year 7 and/or 8 students from 24 schools across Australia during 2022. Hypothesised benefits include reduced drug and alcohol use, and improved wellbeing.

Broad Health ConditionAlcohol use
Tobacco use
Psychological Distress
Cannabis use

Specific Health ConditionMental Health
Addiction
Public Health
Health promotion/education
Mental Health
Other mental health disorders

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,WA

Anticipated date of first participant enrolment1/04/2022

Anticipated date of last participant enrolment22/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

• Year 7 and/or 8 students attending participating schools in 2022
• Fluent in English
• Active student consent provided
• Passive parental consent to participate (QLD Independent schools and NSW public schools) or active parental consent to participate (QLD public and WA independent schools; differing protocols due to varying ethics committee requirements).

Minimum age11 Years

Maximum age15 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

- Schools with fewer than 12 Aboriginal and/or Torres Strait Islander students in Year 7 and/or 8 in 2022
- Schools based outside NSW, WA, and QLD

Trial summary

In a randomised controlled trial (including 3- and 6-month follow-up), the current study will investigate the efficacy of a stepped care approach for treating PTSD in adults. The key research question is whether an online stepped care approach can clinically improve PTSD at a comparable rate to traditional high-intensity PTSD treatment, Cognitive Processing Therapy (CPT) delivered via video call. . The study will also examine potential predictors of clients’ response to low- versus higher-intensity therapy (e.g., PTSD severity, co-morbidity with other psychological disorders, and therapeutic alliance). The feasibility of online stepped care will be evaluated by comparing cost-effectiveness, ease of delivery, and acceptability of the treatments as rated by clients. 

Overall, it is hypothesised that stepped care would be comparable over time to CPT in terms of posttraumatic stress severity (primary outcome), depression severity, quality of life, and acceptability as rated by clients. Stepped care is predicted to have equivalent PTSD severity reductions to CPT as assessed by a standardised diagnostic interview instrument (CAPS-5) to CPT at 6-months post-treatment. However, Stepped care is predicted to cost significantly less that CPT in terms of the amount of therapist time required and economic evaluation of quality of adjusted life years.

Broad Health ConditionPosttraumatic stress disorder (PTSD)

Specific Health ConditionMental Health
Other mental health disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Anticipated date of first participant enrolment22/06/2020

Anticipated date of last participant enrolment30/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

All participants must have been directly or indirectly exposed to a Criterion A trauma, as defined by the DSM-5 and meet diagnostic criteria for PTSD or sub-threshold PTSD (APA, 2013). In the current study sub-threshold PTSD is defined as meeting 3 of 4 Criteria B-E, in addition to meeting Criteria F-H on the CAPS-5. Due to the online nature of the study, participants must have regular and secure access to a computer with a webcam and enough internet data to support video calls with a therapist.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria for the study include scoring a sub-clinical level of PTSD as indicated by a cut off of 30 or below on the PCL-5 (as recommended by Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). Additional exclusion criteria include illiteracy, current uncontrolled psychosis or substance dependence requiring supervised medical withdrawal, and/or significant cognitive impairment. These criteria are on the basis that individuals need to have a sufficient level of functioning to be able to participate in therapy. Further, individuals with a significant risk of harm (e.g., in a current abusive relationship or suicidality with intent) will be excluded as it is recommended that they engage in treatment to help minimise these risks before receiving treatment for PTSD.

Trial summary

This research thus aims to address these gaps in knowledge and practice by characterising how acute doses of Methylphenidate (Ritalin) affect ocular parameters and the visual attentional system. Furthermore, we seek to examine how these changes might be indexed to predict impairment in performance during a neurocognitive and driving task.

Broad Health ConditionAttention deficits

Specific Health ConditionMental Health
Studies of normal psychology, cognitive function and behaviour

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment1/06/2020

Anticipated date of last participant enrolment1/05/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

• Male or female, aged 21 to 45 years;
• Less than 100kg in weight [due to expected metabolism rate of Methylphenidate (Ritalin®), 10mg];
• Willing and able to provide written informed consent;
• Understands and is willing and able to comply with all study procedures;
• Fluent in written and spoken English;
• Must have normal or corrected-to-normal vision;
• Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence;
• Willing to abstain from the following prior to their scheduled visit:
o No food or drinks (except water) within 2 hours prior to testing;
o No caffeine-containing products within 12 hours prior to testing;
o No alcohol within 24 hours prior to testing;
o No medication for at least 1 week prior to testing (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne);
o No illicit substance use for one week prior to, and for the duration of the trial.
o No driving or riding a bicycle or motorbike from the testing site;
o No driving, riding, operating heavy machinery for 24 hours after leaving the site
o No alcohol, drugs, or medication (unless consulted with doctor) for 24 hours after
leaving the site.

Minimum age21 Years

Maximum age45 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

• Unable to understand or comply with testing procedures;
• Inability to speak or read English;
• History of drug or substance abuse or current illicit drug abuse;
• History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders;
• Pregnant, potentially pregnant or lactating;
• Taking any form of ongoing medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne);
• Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol;
• Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
• Have previously participated in this study
• Currently under administrative or legal supervision.

Trial summary

The purpose of this study is to test the impact of medicinal cannabis on quality of life and symptoms in people with advanced cancer.
 
Who is it for?
You may be eligible for this study if you are aged 18 or over, have advanced cancer and a life expectancy of at least 2 months.
 
Study details
Half the participants in this study will receive medicinal cannabis, while the other half will receive placebo. Both are oils taken by mouth, initially once a day, then increasing to a maximum of 3 times a day. The dose will be increased until symptoms are adequately controlled, then maintained for up to 6 months. All participants will provide blood samples, scans and answer questionnaires. We would also like your carer to be involved, if you have one.
 
It is hoped this preliminary study will provide useful information about the risks and benefits of this formulation of medicinal cannabis, and how cannabis is metabolised by the body.

Broad Health ConditionAdvanced Cancer
Palliative Care

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
Peter MacCallum Cancer Centre - Melbourne

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

Postcode
3084 - Heidelberg

Postcode
3050 - Parkville

Postcode
3000 - Melbourne

Postcode
3065 - Fitzroy

Anticipated date of first participant enrolment25/09/2020

Anticipated date of last participant enrolment31/03/2023

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

*Able to provide written informed consent and greater than or equal to 18 years of age.
*Willing and able to comply with all study requirements, including treatment, blood sampling and other assessments.
*Patients with incurable advanced cancer, of any histological subtype.
*Measurable disease based on RECIST 1.1 criteria.
*Life expectancy greater than 2 months.
*Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication and use a medically acceptable form of contraception. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

*Patients with recent change to systemic anticancer treatment (chemotherapy, immunotherapy, targeted therapy, hormonal therapy) on first day of study:

1.	Patients with recent change to systemic anticancer treatment (chemotherapy, immunotherapy, targeted therapy, hormonal therapy) on first day of study:
•	Commenced new anticancer treatment within the last 60 days 
•	Completed anticancer treatment <14 days ago 
•	Planning to receive new anticancer treatment in the next 30 days
2.	Having current radiotherapy or planning to have radiotherapy in the next 30 days
3.	Severe hepatic impairment, as defined by:
•	aspartate aminotransferase (AST) >5 times upper limit of normal, or 
•	alanine aminotransferase (ALT) >5 times upper limit of normal 
4.	Conditions preventing adequate absorption of study drug (including difficulty swallowing medications, intestinal obstruction, inflammatory bowel condition, colitis)
5.	Inadequate renal function, defined as eGFR <30ml/min (using CKD-EPI calculation)
6.	Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants
7.	Current or recent use of cannabis within 30 days prior to study entry. Participants must return a negative drugs of abuse urine test.
8.	Prior clinically significant adverse reaction to cannabis or cannabinoid based medications.
9.	Unwilling to avoid driving or operating machinery whilst on trial.
10.	Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications. Patients on strong CYP3A4 inducers or inhibitors, or on strong CYP2C19 inducers or inhibitors (refer to Appendix 3). 
11.	Psychiatric or neurodegenerative condition which in the opinion of the investigator may compromise patient safety.
12.	Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a highly effective and reliable means of contraception. Male participants must have been surgically sterilised or use a (double if required) barrier method of contraception.
13.	Actively receiving a concurrent investigational product. 

Trial summary

The aim of the study is to test whether a new integrated psychological treatment (INTEGRATE) improves mental health difficulties and decreases the risk of problematic substance use in young people, compared with usual treatment.

Young people between the ages of 12 and 25 (inclusive) will be randomised to receive either i) the INTEGRATE therapy, or ii) treatment as usual (TAU), for 16 weeks in a double-blind, randomised controlled trial (RCT), with followup to 12 months.

The primary hypothesis is that young people who are randomised to receive the INTEGRATE intervention will decrease their alcohol and other drug use compared to participants in the TAU group.

Broad Health ConditionMental Health

Specific Health ConditionMental Health
Other mental health disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Postcode
3030 - Werribee

Postcode
3020 - Sunshine

Postcode
3046 - Glenroy

Postcode
3064 - Craigieburn

Postcode
3337 - Melton

Anticipated date of first participant enrolment11/11/2019

Anticipated date of last participant enrolment31/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Aged 12-25 years inclusive; 
Seeking treatment at headspace for mental ill-health;
At screening, either:
Self-reported use during the past month of greater than or equal to 4x use of cannabis or alcohol, greater than or equal to 1x use of another illicit drug (e.g. methamphetamine, ecstasy, cocaine etc.), assessed using the Timeline Follow-back (TLFB; participants using alcohol only will be required to have consumed in excess of Australian National Guidelines for Alcohol Consumption of >4 standard drinks on greater than or equal to 1 occasion in the past month); OR
Self-reported, clinically-relevant binge alcohol use (i.e. at least 4 standard drinks on at least one occasion) in the past 3 months, which resulted in clear potential for harm or high-risk behaviour (i.e. blackouts, hospital attendance, driving while intoxicated);
Treatment with either a stable dose of an antidepressant or no antidepressant greater than or equal to 2 weeks at screening; 
Sufficient English fluency to complete treatment and participate in the study; 
Ability to provide written informed consent – where the participant is under 18 years of age, a parent or guardian will also be required to provide written informed consent or the young person will consent as a mature minor.   

Minimum age12 Years

Maximum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Lifetime DSM-V diagnosis of a psychotic or bipolar disorder (assessed using structured clinical interview; SCID-5) OR current DSM-V diagnosis of either post-traumatic stress disorder, obsessive compulsive disorder, or an eating disorder for which  the young person is seeking treatment;  
Currently in AOD specific treatment, or open to referral to AOD treatment at headspace; 
Current treatment with antipsychotic medication or mood stabiliser
Acute suicidality at screening, determined by clinical risk assessment;
Participation in another trial, which is likely to affect data for this study, determined by the Investigator; 
Intellectual disability, as indicated by estimated or documented IQ of 70 or less. 

Trial summary

Research has shown that effective psychological prevention programs can prevent depression in approximately 22% of young people at risk. However, a major challenge is delivering these prevention interventions at scale, which have until now been expensive and typically delivered face-to-face. The Future Proofing study will identify how we can use smartphones to deliver effective psychological preventive interventions on a large scale, reaching young people universally by partnering with schools. 

The aim of the study is to determine whether SPARX – an app-based Cognitive Behaviour Therapy (CBT) program can prevent the onset of depression in Year 8 school students, who will be followed up for five years. The study will also examine the effects of the intervention on a range of mental health symptoms, wellbeing, and drug and alcohol use at 12, 24, 36, 48 and 60 months. The study will also examine the effect of a second insomnia app (‘Sleep Ninja’) on depression in those who show high symptoms of depression 12-months after using SPARX. 

The Future Proofing study aims to involve 20,000 Year 8 students from across 400 schools in New South Wales. It is anticipated that receiving a CBT prevention program at this developmental stage will significantly reduce the number of young people who go on to experience depression. 

Broad Health ConditionDepression
Anxiety
Insomnia
Poor sleep

Specific Health ConditionMental Health
Depression
Mental Health
Anxiety

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC

Postcode
2000 - Sydney

Postcode
2300 - Newcastle

Postcode
2310 - Hunter Region

Postcode
2250 - Gosford

Postcode
2500 - Wollongong

Postcode
2541 - Nowra

Postcode
2340 - East Tamworth

Anticipated date of first participant enrolment24/07/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

- Being in Year 8 at a participating school in Australia in 2019 or 2020
- Owning a smartphone
- Having active, parental opt in consent provided
- Providing active personal consent

Minimum age12 Years

Maximum age14 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

None

Trial summary

The purpose of this study is to investigate the safety, tolerability and effectiveness of pharmaceutical grade cannabis for the management of pain.

Who is it for?

You may be eligible for this study if you are an adult who has been prescribed NanaBis™ for either cancer-related or non-cancer related pain. 

Study details

All participants will be followed up by their doctors on a monthly basis for 12 months. These follow ups will involve completion of surveys and provision of information regarding the administration of NanaBis™. Participants will not be asked to undergo any procedures or tests as part of this study. 

It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management. 

Broad Health ConditionCancer related pain
non-cancer related pain

Specific Health ConditionCancer
Any cancer
Anaesthesiology
Pain management

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Anticipated date of first participant enrolment15/07/2019

Anticipated date of last participant enrolment1/05/2024

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Prospective participants greater than or equal to 18 years of age at time of entry on study; 
2.	Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study; 
3.	Prospective participants have been lawfully prescribed NanaBis™ by their Consenting Doctor;
4.	Prospective participants are prescribed NanaBis™ for the management of cancer related or non-cancer related pain;
5.	Prospective participants are able to visit the Consenting Doctor as required while administering NanaBis™ and are able to provide information as required to the Consenting Doctor for the duration of the study;
6.	Prospective participants agree to abstain from using cannabis products other than NanaBis™ for the duration of their participation in the study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria:
1.	Prospective participants will be ineligible if they are under the age of 18 years;
2.	Prospective participants will be ineligible if they are unwilling or unable to sign the Informed Consent Form or cannot understand the Participant Information Sheet provided;
3.	Prospective participants will be ineligible if the Consenting Doctor determines that the prospective participant is unable to fulfill any of the requirements of the study;
4.	Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.
5.  Prospective participants will be ineligible if they are currently using Illicit drugs and/or with alcohol abuse.

Trial summary

Trauma focused cognitive behavioural therapy has long been the standard approach for the treatment of posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) is a manualised treatment protocol based on a cognitive behavioural therapy approach, typically delivered over 12 sessions. Whilst CBT approaches have good efficacy in the treatment of PTSD, the non-response to treatment and dropout rates remain substantial. In military clients, between 20-30% will drop out of treatment prematurely and 40-64% will fail to lose their PTSD diagnosis by the end of treatment (Forbes et al., 2012; Resick et al., 2015, 2017). This research utilises a flexible adaptation of CPT which individualises therapy based on the needs of the client and allows for deviation from the standard treatment protocol. It is hypothesised that this approach will result in less dropout and better good end-state functioning. 

Broad Health ConditionPost traumatic Stress Disorder

Specific Health ConditionMental Health
Other mental health disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Anticipated date of first participant enrolment1/07/2019

Anticipated date of last participant enrolment31/12/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

All participants must be first responders or emergency services personnel (i.e. police, fire service, ambulance officers, CFA) or veterans or active duty military personnel over 18 years of age. Participants must have been directly or indirectly exposed (through witnessing) to a traumatic event (e.g. assault, motor vehicle accident, homicide etc.) four or more weeks prior to inclusion in the study and have met the threshold for PTSD.

Participants must be able to commit to up to 25 therapy sessions (usually conducted weekly).

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria for the study include failing to meet the symptom criteria as assessed on the Clinician Administered PTSD Scale (Blake et al 1990); and scoring a sub-threshold level of PTSD as indicated by a cut off of 33 or below on the PCL-5 (as recommended by the National Centre for PTSD). Other exclusion criteria also include individuals with moderate to severe traumatic brain injury, individuals with uncontrolled psychosis or current substance dependence, those with significant risk of harm (e.g. in current domestic violence situation) or those with active suicidality. 

Exclusion criteria are on the basis that the nature of the therapy (cognitive behavioural) requires a level of cognition and functioning which enables participation in therapy, thus higher levels of traumatic brain injury are excluded. Unmanaged substance abuse or psychosis are also exclusions for treatment, given the nature of the therapy and the need for these issues to be managed either concurrently or before treatment occurs. Rationale for exclusion of participants who are at risk of harm includes that if someone is in imminent danger, or is a danger to themselves or others, then treatment of PTSD is not the immediate treatment goal (Resick, Monson, & Chard, 2014).

Trial summary

The research project will investigate the effects of medicinal cannabis oil among those living within a residential aged care facility and have received a medical diagnosis of dementia.  Using a cross-over N-of-1, randomised double blind trial, participants will receive either an oil-based placebo or medical cannabis oil in the form of purified THC/CBD.  In safety and efficacy trials, medicinal cannabis oil has shown to improve symptoms such as agitation and aggressive, disruptive sleeping patterns and increase appetite.  Medicinal cannabis oil has also shown a number of benefits to other neurodegenerative diseases such as Multiple sclerosis, Parkinson’s disease and Epilepsy.  However we do not know the extent to which medicinal cannabis oil may influence the symptoms associated with dementia at an individual level.  Therefore this project aims to monitor the effects of administering medicinal cannabis oil to those with dementia and to determine if there are any changes in behaviour, quality of life, discomfort or pain levels or weight.  The results from this study will be important in helping us understand the benefits to medicinal cannabis oil within residential aged care facilities and may lead to the continuation of medicinal cannabis oil to be used among this population.
The primary question for this study is:
Does medicinal cannabis affect the behavioural symptoms of care recipients with dementia? 
Secondary research questions include:
1.	Does medicinal cannabis affect care recipients with dementia quality of life?
2.	Does medicinal cannabis affect care recipients with dementia discomfort and pain?

Broad Health ConditionDementia

Specific Health ConditionNeurological
Dementias

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Postcode
6148 - Rossmoyne

Postcode
6157 - Bicton

Postcode
6164 - Success

Postcode
6069 - Ellenbrook

Postcode
6018 - Innaloo

Postcode
6007 - West Leederville

Anticipated date of first participant enrolment7/01/2019

Anticipated date of last participant enrolment9/08/2021

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Live within a residential aged care facility, 
• Aged 65 year or older, 
• Have a diagnosis of dementia, and display at least 3 behavioural symptoms associated with dementia
• Able to speak English, 
• Known compliance to taking medication, and
• Not bed ridden.

Note those with mild dementia will be able to consent to participant in the study themselves.  Those with moderate-to-severe dementia, their next of kin can consent on their behalf if they wish, but will need to speak with an independent medical practitioner prior to their involvement in the study (This is in keeping with the recent changes made to the Western Australian Guardianship and Administration Act of 1990).

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

To minimize the likelihood of an adverse event, people with certain health conditions or on some medications will be excluded from the study. These include:
-Diagnosed of one or more of the following conditions:
-Frontotemporal or Lewy body dementia
-Neurodegenerative disease (Epilepsy or recurrent seizure, Anorexia nervosa)
-Significant psychiatric disorder other than BPSD associated with underlying condition
-Parkinson’s disease
-Significant cardiovascular disease (eg arrhythmias, fibrillation, CHF, angina) clinically uncontrolled in the last year Significant cardiovascular disease (eg arrhythmias, fibrillation, CHF, angina) clinically uncontrolled in the last year
-History of myocardial infarction with manifestations of active cardiac ischemia in the last year
-Clinical event of a stroke within the last 6 months
-Significant liver disease or presence of hepatic encephalopathy (where there are grounds to suspect liver disease excluded as per Child-Pugh classification B or C)
-Significant renal impairment (where there are grounds to suspect kidney disease excluded as per calculated GFR beneath 60ml/min)
-Taking medications that may interact with cannabis metabolism such as Primidone, Phenobarbital, Carbamazepine, Rifampicin, Rifabutin, Troglitazone, Hypericum perforatum, and valproic acid.