Examining the effects of Medical Cannabis in Reducing Relapse among 20 Patients with Methamphetamine Use Disorder
Safety and Effect of Medical Cannabis on Relapse among 20 Patients with Methamphetamine Use Disorder: A Proof-of-Concept Trial
Medical Cannabis Research Australia (Limited)
40 participants
Dec 1, 2026
Interventional
Conditions
Summary
The primary objective of this open-label matched control trial is to examine the safety and efficacy of enriched CBD oil for reducing relapse among people accessing treatment for methamphetamine use disorder. The effect of enriched CBD oil on depression, anxiety and sleep will also be evaluated.
Eligibility
Inclusion Criteria7
- Aged between 18 and 60 years (inclusive);
- Ability to give informed consent;
- Have met DSM-5 criteria for methamphetamine use disorder in the past 12 months;
- Abstinent from methamphetamine for 5-14 days prior to enrolment;
- Agree to a referral to an outpatient clinic for psychological services;
- Previous use of cannabis; and,
- Willing and able to follow study instructions and likely to complete all study requirements.
Exclusion Criteria18
- History of diagnosed psychotic disorder;
- Family history of a diagnosed psychotic disorder or Type I bipolar disorder;
- Admission to an inpatient mental health service for more than one week in the past 12 months;
- Current cannabis use;
- Pregnancy, lactation, or if sexually active is not on effective contraception;
- Prior sensitivity or allergy to CBD or any cannabis-derived product;
- Currently being treated with any medication that contraindicates with CBD, or which in the doctor’s opinion puts the participant at significant risk, could confound the study results, or may interfere significantly with the person’s participation in the study;
- Participation in any investigational drug study within 30 days prior to screening;
- Clinically significant (as judged by the participant’s doctor at alcohol and other drug service) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the service;
- Abnormal liver or thyroid function, or haematological findings (>15% above or below normal range);
- Acute or unstable systemic medical disorder;
- History of brady- or tachy-dysrhythmias;
- History of heart failure or heart disease;
- Positive screen for hepatitis B surface antigen, Hepatitis C Virus and Human Immunodeficiency Virus;
- Any condition, which in the doctor’s opinion, puts the participant at significant risk, could confound the study results or may interfere significantly with the participant’s participation in the study;
- Received oral pharmacotherapy for methamphetamine relapse prevention in the past 14 days;
- Received naltrexone implant pharmacotherapy in the past 6 months; or,
- Anticipated need for surgery or hospitalisation during the study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This trial will investigate a Cannabidiol (CBD) dominant cannabis oil product, approximately 200mg/ml of CBD, self-dosed sublingually using an oral syringe twice daily, morning and evening. The study clinician will instruct and coach each participant to self-administer the dose of the study drug via the syringe contained in the drug packaging. Dosing will follow a daily protocol regime, with participants' doses titrated according to positive clinical response and considering any adverse effects. Participants will stay on their last effective dose till the end of the study period. The initial dose will be 0.2ml with a possible maximum dose of 6 ml per day, this dose may be up to a maximum of 1164mg of CBD per day.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12620000847910