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 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.
• Individuals of at least 25 years of age or older;
• Diagnosed with OUD as per DSM-5 criteria;
• Initiated or re-initiated methadone-based OAT within the past 30 days prior to study entry;
• Cannabis-use experienced, defined as having used any amount of cannabis in the six months prior to the screening visit;
• Willing to only use study-provided cannabis as directed by study protocol, including abstention from non-study cannabis and cannabinoids;
• Agree to keep all study medication stored in a secure location and not to share/distribute study medication to any other individual;
• If assigned female sex at birth:
‣ 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
⁃ If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;
• Ability to understand and comply with study protocol procedures and to provide written informed consent.
∙ 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:
• Participants who have not experienced a study medication-related serious adverse event during Phase 1;
• Participants who have not been lost to follow-up during Phase 1.