Using cannabis oil to support opioid addiction treatment

Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy for Individuals Living With Opioid Use Disorder: A Phase II, Placebo-controlled, Blinded, Pilot Study to Assess Safety and Feasibility (THC-MMT)

This study is trying out a balanced cannabis oil to see if it can help people with opioid addiction who are also getting treatment with methadone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 25 Years and up
• Sex: All
• Sponsor: BC Centre on Substance Use (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT05985850 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 25 and older with a diagnosis of opioid use disorder who have recently started methadone-based OAT.

Not a fit: Patients who have not used cannabis in the past six months or those who are not currently undergoing methadone-based OAT may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of opioid addiction treatment and improve patient outcomes.

How similar studies have performed: Other studies exploring cannabis as an adjunct therapy for addiction have shown promise, but this specific approach is relatively novel.

Eligibility criteria

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 this trial is running

Vancouver, British Columbia

• 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

Conditions: Opioid Use Disorder, Methadone, Cannabis, Fentanyl, addiction, Harm Reduction, Opioid, Pain