NCT05985850 Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy
| NCT ID | NCT05985850 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | BC Centre on Substance Use |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2024-05-23 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.
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.
Contact & Investigator
M Eugenia Socias, MD, MSc.
PRINCIPAL INVESTIGATOR
Assistant Professor, Department of Medicine, University of British Columbia
Frequently Asked Questions
Who can join the NCT05985850 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05985850 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05985850 currently recruiting?
Yes, NCT05985850 is actively recruiting participants. Contact the research team at josie.kanu@bccsu.ubc.ca for enrollment information.
Where is the NCT05985850 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05985850 clinical trial?
NCT05985850 is sponsored by BC Centre on Substance Use. The principal investigator is M Eugenia Socias, MD, MSc. at Assistant Professor, Department of Medicine, University of British Columbia. The trial plans to enroll 24 participants.