Trial summary

The proposed clinical trial will evaluate the bioavailability of Satipharm CBD capsules compared to a CBD oil at a dose of 100mg. The trial will also determine if there is bioequivalence between the Swiss manufactured Satipharm CBD capsules and Australian manufactured CBD capsules. 
12 healthy male participants will receive one single oral dose of 100 mg cannabidiol (1mL of the reference drug or two tablets of the test drug) after an overnight fast in each of the 3 periods according to a sequence determined by randomisation. 
In each study period, participants will take different products (either one dose of the 2 Test Drugs or one dose of Reference Drug) with a minimum 13 day wash-out between each study period. The study hypothesis is that the Australian manufactured CBD capsules will show an equivalent bioavailability at the specified time points to that of the Swiss manufactured CBC capsules.

Broad Health ConditionChronic pain

Specific Health ConditionAlternative and Complementary Medicine
Other alternative and complementary medicine

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Novatrials - Kotara

Postcode
2289 - Kotara

Anticipated date of first participant enrolment4/09/2023

Anticipated date of last participant enrolment4/10/2023

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

1. Healthy male participants aged between 18 and 40 years,
2. Ability to communicate adequately with the investigator or their representatives
3. Ability to understand and agreement to comply with the study requirements and assessments
4. Provision of written informed consent
5. Non-smokers, non-vaper
6. Negative alcohol breath test results
7. Body Mass Index ranged between 18.5-30 kg/m2
8. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 40 to 100 bpm
9. Laboratory results within normal range or clinically non-significant (FBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results is negative (amphetamine, benzodiazepine, cannabinoid, cocaine, opiate),
10. He and his female partner will use contraception during the study and at least 7 days after the study.
11. Willing to fast overnight from 9pm, three times, prior to each treatment

Minimum age18 Years

Maximum age40 Years

GenderMales

Can Healthy volunteers participate?Yes

Key exclusion criteria

1. Who are not suitable to any of inclusion criteria.
2. Participants suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator’s judgement,
3. Who have known allergy for cannabidiol and/or any other ingredients of the products
(excipients),
4. History of difficulty of swallowing.
5. Participants who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
6. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal (and/or GI Surgery), renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
7. Use of any drug including over-the-counter (OTC) that may have an interaction with Cannabidiol within 2 weeks prior to each treatment
8. History of drug or alcohol abuse, defined as diagnosed substance abuse disorder.
9. Use of any Cannabis or other illicit drug in past month, confirmed by negative drug screen
10. Regular use of more than 2 units of alcohol per day or 10 units per week and/or positive
alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25
mL spirits).
11. Participants who have taken any grapefruit or grapefruit juice during 7 days prior to drug
administration, during the study.
12. Participants who have given more than 400 mL blood within the last two months before the first treatment and participants who have participated in any drug research within the last two months before the first treatment.
13. Participants who have a relationship with the study team.

Trial summary

Physical inactivity is estimated to cause almost one in ten premature deaths worldwide. A pilot clinical trial conducted by the Lambert Initiative (University of Sydney) and scientists at Griffith University found that the non-intoxicating phytocannabinoid, cannabidiol (CBD), had an effect to increase ratings of pleasure during aerobic exercise; specifically, in endurance-trained males running at a fixed, moderate intensity. This initial finding suggests that CBD has the potential to support physical activity (PA) participation. However, further research is required to confirm and better understand the observed effect. The overall objective of this trial is to determine whether CBD can enhance affective responses to self-paced aerobic (running) exercise in recreationally active individuals – and, thus, support PA participation. Participants will complete two treatment sessions involving the oral administration of CBD (150 mg) or a placebo in a randomised, double-blind, crossover design. Affective valance will be measured at baseline (pre-treatment), pre-exercise, at 6-lap intervals throughout a 25-lap run (~10 km) on a standard outdoor athletics track, and post-exercise using validated scales. Exercise enjoyment, motivation to exercise, and exercise self-efficacy will also be assessed. We hypothesise that CBD will increase ratings of pleasure during self-paced aerobic exercise – as well as exercise enjoyment, motivation, and self-efficacy.

Broad Health ConditionPhysical Inactivity

Specific Health ConditionPhysical Medicine / Rehabilitation
Other physical medicine / rehabilitation

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment17/07/2023

Anticipated date of last participant enrolment21/08/2023

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

(a)	Greater than or equal to 18 years of age
(b)	Able to perform aerobic exercise as assessed using the ‘Physical Activity Readiness Questionnaire for Everyone ’ (PAR-Q+).
(c)	Proficient in English (i.e., able to provide informed consent).

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

(a)	A self-reported history of allergic reaction to cannabis or cannabinoid-containing products
(b)	A self-reported history of liver disease or renal disease
(c)	A self-reported or physician-suspected history of drug/alcohol dependence (excluding nicotine dependence)
(d)	Current suicide ideation (i.e., a score >0 on Question 9 of the 'Patient Health Questionnaire' or at the physician's discretion)
(e)	Regular (i.e., more than twice weekly) use of cannabis or CBD
(f)	Unwilling to adhere to trial procedures
(g)	Pregnant, lactating, or trying to conceive.

Trial summary

This project investigates how low and moderate doses of alcohol affects eye movement patterns during simulated driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication

Broad Health ConditionNeurological

Specific Health ConditionNeurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment29/05/2023

Anticipated date of last participant enrolment26/02/2024

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Male or female, aged 21 to 55 years
• 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
• Previous history of alcohol consumption in a single drinking session to an estimated BAC of 0.08% with no known adverse reaction [more than 5 standard drinks (female) or 6 standard drinks (male) on single drinking occasion]
• Must have normal or corrected-to-normal vision
• Is a regular driver (>50km/week) with three years of driving with a full Australian or International driver’s licence (no ‘P-Plate’ drivers).
• Weight under 100kg
• 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 12 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 12 hours after leaving the site
o No alcohol, illicit drugs, or medication (unless consulted with doctor) for 12 hours after leaving the site.

Minimum age21 Years

Maximum age55 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 abuse or dependence or current illicit drug abuse
• Current neurological, psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
• Pregnant or lactating
• Taking any form of medication within one week of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
• Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol
• Weight over 100kg
• Moderate-severe current depression (Beck Depression Inventory score of greater than or equal to 20)
• Severe current anxiety (Beck Anxiety Inventory score greater than or equal to 16)
• Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
• Currently under administrative or legal supervision.

Trial summary

SDC-1801 is a small molecule tyrosine kinase 2 (TYK2)/janus kinase 1 (JAK1) inhibitor entering clinical development for the treatment of participants with inflammatory diseases such as psoriasis. The nonclinical good laboratory practice (GLP) toxicology and safety pharmacology studies indicate that it is appropriate to cautiously assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SDC-1801 in the context of a well-designed, first-in-human (FIH) study.

It is reasonable to say that the risk of adverse events (AEs) for JAK inhibitors are broadly similar to those for other biological disease modifying antirheumatic drug (bDMARD) classes. However, concealed within this, there are also important differences between JAK inhibitors and bDMARDs. Tofacitinib and baricitinib have AE profile characteristics that distinguish them from the other bDMARD classes, with signals including an increased risk of herpes zoster reactivation, elevation in lipids, and decreases in haemoglobin and lymphocytes (including natural killer cells).

Based on available nonclinical data, SDC-1801 is a potent and selective small molecule TYK2/JAK1 inhibitor currently in development for inflammatory and autoimmune indications, and it has the potential to have an improved safety profile and similar efficacy profile compared with other JAK inhibitors and specific TYK2 inhibitors.

A randomised, placebo controlled, dose-escalation, sequential group design is regarded as an appropriate standard design to initiate the cautious assessment of safety, tolerability, and PK of a new investigational product in healthy volunteers.

The chosen sample sizes will provide sufficient data to make an initial assessment of the safety, tolerability, and PK of SDC-1801.

Broad Health ConditionPlaque Psoriasis

Specific Health ConditionInflammatory and Immune System
Autoimmune diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD,VIC

Hospital
Nucleus Network - Melbourne

Hospital
Nucleus Network Brisbane Clinic - Herston

Postcode
3004 - Melbourne

Postcode
4006 - Herston

Anticipated date of first participant enrolment4/06/2023

Anticipated date of last participant enrolment7/05/2024

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

Inclusion Criteria for Parts 1 & 2

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) prior to any screening evaluations.
2. Healthy males and females between 18-55 years of age on date of signing ICF.
3. Body mass index (BMI) between 18-32 kg/m2, inclusive.
4. Participants in good health based upon the results of a medical history, physical  examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests as determined by the Investigator.
5. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and
alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) values less than or equal to 1.3 x upper limit of normal (ULN). Total bilirubin less than or equal to 1.3 x ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is less than or equal to ULN.
6. Participant must be able and willing to comply with restrictions on prior and concomitant medication.
7. Negative for severe acute respiratory syndrome coronavirus-2 infection.
8. Non-smoker and not using any nicotine-containing products
9. Negative screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
10. Must agree to avoid prolonged exposure to the sun and avoid other ultraviolet light sources (e.g. tanning beds) during the study period and for 7 days after the last dose of study drug.
11. Adherence to effective contraception or are proven post-menopausal
12. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) or history of untreated or inadequately treated latent or active TB infection

Minimum age18 Years

Maximum age55 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1. Known hypersensitivity to investigational medicinal product (IMP) ingredients or history of
a significant allergic reaction to IMP ingredients as determined by the Investigator
2. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV),
or history of hepatitis from any cause with the exception of hepatitis A
3. History of or a current immunosuppressive condition (e.g. human immunodeficiency virus
[HIV] infection).
4. Having any illness, judged by the Investigator as clinically significant, in the 3 months prior to the first dose of study drug.
5. Current clinically significant infection or clinically significant infection within 6 months of
first dose of study drug
6. History of chronic or recurrent infectious disease within the last 2 years.
7. Symptomatic herpes zoster or herpes simplex within 12 weeks of first dose of study drug, or more than one episode of local herpes zoster, or a history of disseminated zoster.
8. Pregnant or breast feeding participants.
9. Presence or sequelae of gastrointestinal, liver, or kidney (estimated creatinine clearance
less than or equal to 80 mL/min, using the Cockcroft-Gault formula; if calculated creatinine clearance is less than or equal to 80mL/min a 24-hour urine collection may be performed to assess renal function) disease,
10. History of malignancy within the past 5 years (except for basal cell carcinoma of the skin
that has been treated and with no evidence of recurrence)
11. Clinically significant abnormalities detected on 12-lead ECG
12. Clinically significant abnormalities detected on vital signs.
13. Significant blood loss (including blood donation [>500 mL]), or transfusion of any blood
product within 12 weeks prior to Screening.
14. Treatment with any drug known to have a potential for major organ toxicity in the last
3 months before the first dose of this study drug.
15. Treatment with any medication (including over-the-counter and/or prescription medicines [including hormonal replacement therapy for postmenopausal participants], dietary supplements, nutraceuticals, recreational drugs, vitamins and/or herbal supplements) within the last 2 weeks or 5 half-lives of that drug (whichever is longer) prior to the first dose of this study drug. Occasional paracetamol (maximum dose of 2 g/day and 10 g/2 weeks) is permitted for use at any time during the study.
16. Vaccination with live virus, attenuated live virus, or any live viral components within the
6 weeks prior to the first dose of study drug or is to receive these vaccines during study
treatment or within 8 weeks following completion of study treatment. 
17. Routine household contact (during study treatment or for 8 weeks following completion of study treatment) with individuals who have received vaccination with live virus or
attenuated live virus.
18. Active drug or alcohol abuse
19. Consumption of a large quantity of caffeinated coffee or tea (>6 cups per day) or equivalent.
20. Consumption of grapefruit, grapefruit juice, or citrus fruits within 7 days prior to the first dose of study drug and until collection of the final PK blood sample.
21. Current or previous participation in another investigational research study where the
participant has received a drug, drug/device, or biologic within 12 weeks or 5 of its
half-lives (whichever is longer) prior to the first dose of this study drug.
22. Investigator or other study site staff who is directly involved in the conduct of the study and their relatives.
23. Any condition or circumstances that in the opinion of the Investigator may make a
participant unlikely or unable to complete the study or comply with study procedures and
requirements.

Trial summary

Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 9 women and those assigned female at birth in Australia (~830,000 people)  and has no cure. My research has shown that patients often have to make impossible choices between being in pain, and the worry of dependence, addiction and impairment due to the current drug choices. Effective pain relief with a low to negligible risk of addiction is the holy grail for people with endometriosis. Various phytochemicals (mainly cannabinoids) from Cannabis spp have well described analgesic, anti-inflammatory, anxiolytic, anti-depressant and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, by cannabis. Our previous research has shown that women with endometriosis in Australia and New Zealand are using cannabis, mostly from illicit sources, to manage their pain and other symptoms. We hypothesise that usage of either CBD isolate alone or in combination with THC containing canabis flower will reduce pelvic pain severity, and presentations to the emergency department. The primary aim of this project is to determine the feasibility, safety and acceptability of two different medicinal cannabis interventions in people with endometriosis

Broad Health Conditionendometriosis

Specific Health ConditionReproductive Health and Childbirth
Menstruation and menopause
Alternative and Complementary Medicine
Other alternative and complementary medicine
Reproductive Health and Childbirth
Other reproductive health and childbirth disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment1/03/2023

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Approved

Key inclusion criteria

Aged 20 years and over; able to read and write English fluently, be residing in the state of Victoria for the duration of the trial period, have regular menstruation (one period every 24-35 days); At least two presentations to ED over the previous six-month period for pelvic pain; Diagnosis of endometriosis via laparoscopy, MRI or Ultrasound imaging by a medical doctor with input from an imaging specialist with specific endometriosis expertise; Have not used illicit cannabis or prescribed cannabinoid-based medications in the previous three months; Report no current, or history of, hazardous cannabis use or dependency; Agree to keep all study product stored in a secure location and not to share/distribute cannabis to any other individual; has access to a smartphone (either iOS or Android). If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period

Minimum age20 Years

GenderFemales

Can Healthy volunteers participate?No

Key exclusion criteria

Endometriosis-related surgery in the previous six months; Must not have started, stopped or had a significant change in dosage of any endometriosis specific medication in the last three months including contraceptives, GNRH-a, and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusion); Upon review of medical or psychiatric history, must not have any current or past diagnosis that would be considered a risk to participation in the study, such as schizophrenia, psychosis, bipolar disorder, dissociative disorder, personality disorder, cannabis use disorder or obsessive-compulsive disorder; Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal or neurological disease (determined by the medical monitoring team).

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

Medicinal cannabis predominantly containing cannabidiol (CBD) is often prescribed for the relief of cancer symptoms. However, it is illegal to drive in Queensland while taking tetrahydrocannabinol (THC) irrespective of whether it is for recreational or medicinal use. Unfortunately, very few CBD dominant products are completely free of THC, with most products containing traces of THC. Whether a CBD-dominant preparation with trace THC taken as an oil preparation would return a positive result on a roadside screening test is an important gap in the literature. Therefore, the aim of this study is to assess whether THC is detectable in saliva, blood, and urine after administration of CBD-dominant medicinal cannabinoid preparations in cancer patients.

Who is it for?
You may be eligible for this study if you are aged 18 years or over, have been diagnosed with cancer, are known to the Cancer Care Service, and are experiencing cancer-related symptoms.

Study details
Participants will be allocated to one of three treatment groups based upon doctor/patient preference and product availability, involving either LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL), LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL), or LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) administered as an oral solution. Treatment will be administered for a total of 27 days, starting at a dose of 0.25ml daily and increasing every 3 days for the first 14 days, reaching a max dose of 1ml twice a day. The day 14 dose is then continued for days 15 - 27. If the participant experiences adverse effects, the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants will be asked to return for study visits on days 7, 14, and 28 after commencing the treatment to collect saliva, urine, and blood samples for the detection of THC. During these visits, questionnaires regarding cancer symptoms will also be completed, as well as an assessment of any adverse effects experienced as a result of treatment.

It is hoped that this study may show that CBD-dominant preparations do not produce a detectable level of THC in clinical samples, while showing an improvement in cancer symptoms with minimal side effects. This may help to inform advice given to patients taking medicinal cannabinoid preparations in future.

Broad Health ConditionCancer

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Mater Private Hospital - South Brisbane

Hospital
Mater Private Hospital Springfield - Springfield Central

Hospital
Mater Private Hospital Redland - Cleveland

Postcode
4101 - South Brisbane

Postcode
4300 - Springfield Central

Postcode
4163 - Cleveland

Anticipated date of first participant enrolment29/08/2022

Anticipated date of last participant enrolment29/08/2025

Phase of TrialPhase 3 / Phase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Patients with histologically proven cancer known to the Cancer Care Service who:
- Have had an ESAS TSDS greater than or equal to 10 for cancer or cancer-treatment-related symptoms, and at least one individual ESAS score greater than or equal to 3 
 - Performance Status AKPS (Australia-modified Karnofsky Scale score) of greater than or equal to 30 
- Aged 18 years, English-speaking (or have an interpreter available)
- Have a negative THC urine test at baseline
- Have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12 weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and for at least 12 weeks following the last dose of the study drug
- Are able to tolerate oral medications 
- Are willing to receive standard palliative care as necessary and delivered by their primary treating team
- Physician assessed ability to comply with all trial requirements, agree to attend scheduled clinic appointments and adhere to dose titration schedules as directed
- Agree to use no other cannabis-based products for the duration of the trial
- Understand that it is illegal to drive whilst taking THC containing cannabis products, to take cannabinoid products outside of Australia or to endorse legal documents whilst taking THC containing cannabis products
- Able to provide fully informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients with:
- A history of hypersensitivity to any cannabinoid
- Unstable untreated cardiovascular disease (hypertension, ischaemic heart disease, congestive cardiac failure) 
- Severe hepatic impairment (total bilirubin greater than or equal to 1.5 times the upper limit of the institution’s normal range. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or equal to 3.0 time the upper limit of the institution’s normal range; subjects with liver metastasis AST and ALT of greater than or equal to 5.0 times the upper limit of normal 
- Severe renal impairment (eGFR greater than or equal to 20mL/min/1.73m2)
- A history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia)
- Known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination scoring greater than or equal to 27 for any substance
- History suggesting that drug diversion may be a risk for them or their family/carers  
- Females who are pregnant or lactating 
- Concurrent or participation in a trial of a new clinical entity within the last 28 days 
- Treatment with a new specific anticancer agent (chemotherapy, hormone therapy, targeted or immunotherapy or radiation within the last 7 days 

Trial summary

The objective of this observational study is to examine whether there is a change or improvement in standardised and validated patient reported outcome measures, whilst using a standardized and pharmaceutical oral formulation of medicinal cannabis (MC) oil to treat Musculoskeletal (MSK) chronic pain over a 12-week period, or until they cease taking the medication. The study will also record any adverse outcomes that result whilst taking the medication. It is hoped conclusions will be drawn as to whether or not this particular medication warrants further and more rigorous clinical trial investigation as an interventional treatment for chronic pain, in this patient cohort. 
 

Broad Health ConditionChronic pain of musculoskeletal origin

Specific Health ConditionMusculoskeletal
Osteoarthritis
Musculoskeletal
Other muscular and skeletal disorders
Inflammatory and Immune System
Rheumatoid arthritis
Anaesthesiology
Pain management

Recruitment statusRecruiting

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

Anticipated date of first participant enrolment1/06/2023

Anticipated date of last participant enrolment1/06/2024

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

•	Aged over 18 years
•	A diagnosis of treatment resistant chronic pain of musculoskeletal origin
•	Ability to give informed consent
•	Willing and able to follow study instructions and likely to complete all PROM requirements via study website
•	Able to provide informed consent
•	Have a life-expectancy of >3 months
•	Understand that there is a risk of prosecution if driving a car while under treatment
•	Patient has been identified as eligible to receive medicinal cannabis under the TGA Special Access Scheme/Authorised by the Principal Investigator for chronic pain
•	Participants must have been lawfully prescribed Levin Balance, Levin CBD+ or Levin THC+  by the Principal Investigator
•	Participants agree to abstain from using another cannabis product other than their Levin Health product for the duration of their enrolment in the study

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	have cognitive impairment
•	are pregnant
•	are unable to speak, read and/or write in English
•	are unable to provide informed consent
•	are unable to provide an email address
•	have received prescription medicinal cannabis within the last 4 weeks
•	are using illicit cannabis  
	

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

People with kidney failure suffer a variety of symptoms and poor quality of life. Common symptoms include pain, itch, nausea, anorexia, restless legs, difficulty sleeping and fatigue. There are few treatments available, and many symptoms do not respond or go untreated. Cannabinoids, derived from cannabis, have a wide range of therapeutic effects, including showing promise as treatments for pain, itch, and nausea. This makes them promising treatments for some symptoms of kidney failure. Also, cannabinoids are predominantly hepatically metabolized, with the limited available data suggesting their pharmacokinetics may not be substantially affected by reduced kidney function. However, no studies testing these agents in people with kidney failure have been published.

The two best studied, and most widely used cannabinoids are tetrahydrocannabinol (THC), which has psychoactive and muscle relaxing actions and may also be analgesic and antiemetic, and cannabidiol (CBD), which has anti-convulsant, anti-inflammatory, and anxiolytic actions. CBD is typically better tolerated and minimises the potentially adverse psychoactive actions of THC. Combined formulations of the two cannabinoids are common in clinical practice.

Before embarking on studies of the efficacy of cannabinoids on symptoms in people with kidney failure it is important to first show that they are safe and well tolerated. Hence, the aim of the present study is to determine the safety and tolerability, and pharmacokinetic parameters of cannabinoids in people with kidney failure. The staggered initiation of CBD,  is designed to permit assessment of the safety and tolerability of CBD alone,  in a manner that minimises the potential for adverse effects in this vulnerable population. The experience gained with this canabidiol will inform the design of future studies.

Broad Health ConditionChronic symptoms management in chronic kidney disease patients

Specific Health ConditionRenal and Urogenital
Kidney disease

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St George Hospital - Kogarah

Postcode
2217 - Kogarah

Anticipated date of first participant enrolment28/02/2023

Anticipated date of last participant enrolment30/06/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Adults greater than or equal to 18 years with kidney failure as defined by:
a.	eGFR less than or equal to 15ml/min/1.73m2 (measured by Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] equation) on at least two blood tests within the past three (3) months
OR
b.	receiving maintenance dialysis (haemodialysis or peritoneal dialysis),
2.	A score of greater than or equal to 4 on at least one of the following domains of ESASr-Renal: pain, nausea, lack of appetite, itching, problem sleeping, restless legs, tiredness, and
3.	Participant and treating clinician are willing to perform the study procedures.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Active on the kidney transplant waitlist
2.	Taking a disqualifying concomitant medication that cannot be ceased during the study period.
3.	Use of recreational or prescribed cannabis products in the past 4 weeks and unwilling to refrain from using such products for the duration of the present study.
4.	Unstable mood disorder. Defined as commencing therapy for depression or anxiety (pharmacotherapy or non-pharmacotherapy) within the past 3 months, or in the opinion of the investigator.
5.	Pregnant or breast-feeding
6.	Significant hepatic disease, defined as either of the following
a.	Known or suspected cirrhosis (of any degree)
b.	Elevated liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase [GGT]) more than 2x the upper limit of normal on blood tests taken within 3 months of the date of screening. 
7.	Unwilling or unable to follow study procedures
8.	Unwilling or unable to refrain from driving within 24 hours of receiving THC wafer.
9.	In the opinion of the treating investigator: death likely within three months
10.	Taking clopidogrel AND meeting at least ONE of the following conditions in the past (6) months:
a.	Placement of a coronary artery stent 
b.	Acute myocardial infarction 
c.	Cerebrovascular accident 

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.