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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
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Adequacy of Dose
Blinding effectiveness
+3 moreOther study objectives
Anxiety
Changes in health-related quality of life
Changes in substance-use related problems
+6 moreTrial 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.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,518,049 Total Patients Enrolled
1 Trials studying Fentanyl
27 Patients Enrolled for Fentanyl
BC Centre on Substance UseLead Sponsor
3 Previous Clinical Trials
10,234 Total Patients Enrolled
M Eugenia Socias, MD, MSc.Principal InvestigatorAssistant Professor, Department of Medicine, University of British Columbia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I didn't have serious side effects from the study drug and wasn't lost to follow-up in Phase 1.I will only use the cannabis provided by the study and avoid any other forms.I started or restarted methadone treatment in the last 30 days.I have a history of severe heart, lung, brain, kidney, or liver disease.I can avoid driving or using machines for 10 hours after taking the study medication.I am taking medication that may not mix well with cannabinoids.I am 25 years old or older.I or my close family have a history of schizophrenia or related disorders.I cannot become pregnant or agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Aurora 1:1 Drops (Indica)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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