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Cannabis Oil Adjunct for Opioid Use Disorder (THC-MMT Trial)

Phase 2
Waitlist Available
Led By M Eugenia Socias, MD, MSc.
Research Sponsored by BC Centre on Substance Use
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Summary

This trial will study if cannabis oil can help people with opioid use disorder when taken alongside methadone treatment.

Who is the study for?
This trial is for adults over 25 with opioid use disorder who recently started methadone treatment. Participants must agree to only use the study's cannabis oil, secure it properly, and not share it. Women of childbearing age must use contraception and have a negative pregnancy test.Check my eligibility
What is being tested?
The study tests if THC:CBD cannabis oil can help alongside methadone therapy for opioid addiction in a community setting. It compares the effects of this cannabis oil against a placebo in people already using methadone.See study design
What are the potential side effects?
Possible side effects include typical reactions to cannabinoids such as drowsiness, dry mouth, changes in appetite or mood, dizziness, and potential interactions with certain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Adequacy of Dose
Blinding effectiveness
+3 more
Secondary outcome measures
The monthly enrolment rates
The number of potential participants referred to the study
The proportion of eligible participants who are willing to be randomized, willing to initiate the intervention and willing to complete 12-week assessments by study arm
+2 more
Other outcome measures
Anxiety
Changes in health-related quality of life
Changes in substance-use related problems
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Aurora 1:1 Drops (Indica)Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,460,495 Total Patients Enrolled
BC Centre on Substance UseLead Sponsor
2 Previous Clinical Trials
234 Total Patients Enrolled
M Eugenia Socias, MD, MSc.Principal InvestigatorAssistant Professor, Department of Medicine, University of British Columbia

Media Library

Aurora 1:1 Drops (Indica) Clinical Trial Eligibility Overview. Trial Name: NCT05985850 — Phase 2
Cannabis Research Study Groups: Aurora 1:1 Drops (Indica), Placebo
Cannabis Clinical Trial 2023: Aurora 1:1 Drops (Indica) Highlights & Side Effects. Trial Name: NCT05985850 — Phase 2
Aurora 1:1 Drops (Indica) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05985850 — Phase 2
~16 spots leftby Sep 2025