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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Josie Kanu, BSc
josie.kanu@bccsu.ubc.ca
6045001102
Time Frame
Start Date: 2024-05-23
Estimated Completion Date: 2027-03
Participants
Target number of participants: 24
Treatments
Experimental: Aurora 1:1 Drops (Indica)
Aurora 1:1 Drops (Indica)~Balanced 1:1 ratio of THC and CBD packaged in a 30 mL bottle:~THC: 16.8 mg/g (+/- 15%) CBD: 16.8 mg/g (+/- 15%)~Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.
Placebo_comparator: Placebo
Formulated using the same medium chain triglyceride (MCT) oil as Aurora 1:1 Drops (Indica)~Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: BC Centre on Substance Use

This content was sourced from clinicaltrials.gov