Using cannabis oil to support opioid addiction treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the safety and feasibility of a balanced 1:1 ratio of tetrahydrocannabinol (THC) and cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based opioid agonist therapy (OAT) for individuals with opioid use disorder (OUD). The study consists of two phases: a 12-week double-blind, randomized controlled trial with 24 participants, followed by a 12-week open-label extension where all participants receive the cannabis oil. Participants will continue to receive standard OUD clinical care throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Individuals of at least 25 years of age or older;
2. Diagnosed with OUD as per DSM-5 criteria;
3. Initiated or re-initiated methadone-based OAT within the past 30 days prior to study entry;
4. Cannabis-use experienced, defined as having used any amount of cannabis in the six months prior to the screening visit;
5. Willing to only use study-provided cannabis as directed by study protocol, including abstention from non-study cannabis and cannabinoids;
6. Agree to keep all study medication stored in a secure location and not to share/distribute study medication to any other individual;
7. If assigned female sex at birth:

   1. Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and over 45 years of age); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or
   2. If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;
8. Ability to understand and comply with study protocol procedures and to provide written informed consent.

Inclusion criteria for Phase 2

In addition to meeting all eligibility criteria outlined in Phase 1, participants will be eligible for Phase 2 provided they meet ALL the following criteria at Week 12:

1. Participants who have not experienced a study medication-related serious adverse event during Phase 1;
2. Participants who have not been lost to follow-up during Phase 1.

Exclusion Criteria:

1. Any disabling, severe, or unstable medical or psychiatric condition that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent, as assessed by medical and psychiatric history, physical examination, vital signs, and/or laboratory tests;
2. Any severe or unstable co-morbid substance use disorder (e.g., delirium tremens, acute alcohol intoxication) that, in the opinion of the study physician, precludes safe participation in the study;
3. Currently pregnant or breastfeeding, or planning to become pregnant;
4. Known or suspected allergy or hypersensitivity to cannabinoids;
5. History of respiratory disease, severe cardiovascular, cerebrovascular, renal or liver disease;
6. Current or historic cannabis use disorder;
7. Taking warfarin, clopidogrel, clobazam, theophylline, clozapine and olanzapine medications as they may interact with cannabinoids in a clinically significant manner if they cannot be switched to a different medication;
8. Any personal or family history (first degree relative) of primary psychotic disorders (i.e., schizophrenia, schizoaffective disorder) as per DSM-5 criteria;
9. Unable to abstain from driving any vehicle or operating machinery for at least 10 hours after taking the study medication. In cases where impairment persists beyond the initial 10-hour period, participants must continue to adhere to these restrictions until the impairment resolves;
10. Actively participating in other interventional clinical trial(s);
11. Incarcerated, pending legal action or other reasons that might prevent completion of the study.

Where it's running

• Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: M Eugenia Socias, MD, MSc. — Assistant Professor, Department of Medicine, University of British Columbia
• Study coordinator: Josie Kanu, BSc
• Email: josie.kanu@bccsu.ubc.ca
• Phone: 6045001102

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating daily dosing methods of methadone for pain and opioid use disorder

  This study is testing whether taking methadone once or twice a day can better help people with chronic pain and opioid use disorder who are already on methadone treatment.

  Recruiting Phase 2/3 University of Maryland, Baltimore · Baltimore, Maryland · NCT05459402

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

  Recruiting Friends Research Institute, Inc. · Philadelphia, Pennsylvania · NCT07787039

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.