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Cannabidiol for Opioid Use Disorder

Phase 2
Recruiting
Led By Yasmin Hurd, PhD
Research Sponsored by Yasmin Hurd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current buprenorphine maintenance treatment with a dose of ≥ 8mg/day (maximum: 24mg/day), AND urinary toxicology positive for buprenorphine
Current methadone maintenance treatment with a dose of ≥ 40mg/day, (maximum: 200mg/day), AND urinary toxicology positive for methadone and EDDP; OR
Must not have
Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil)
History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: >4x the upper limit of normal (ULN) per laboratory criteria for AST or ALT, >1.5x ULN for bilirubin or <30mL/min/1.73m2 eGFR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-weeks and 8-weeks
Awards & highlights

Summary

This trial is trying to find out if cannabidiol (CBD) can help reduce craving and relapse in people with opioid use disorder (OUD). The first part of the project was a

Who is the study for?
This trial is for individuals with opioid addiction who are currently on opioid agonist therapy. It aims to see if CBD can help reduce cravings and anxiety related to their condition.Check my eligibility
What is being tested?
The study tests two different doses of CBD (200mg and 400mg) against a placebo to determine its effectiveness in reducing craving and relapse in people with opioid use disorder.See study design
What are the potential side effects?
While the side effects of CBD at these doses aren't fully known, possible reactions may include tiredness, changes in appetite or weight, diarrhea, and interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a daily buprenorphine treatment between 8mg and 24mg, and my urine test was positive for buprenorphine.
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I am on a methadone treatment of 40-200mg/day and my urine test shows methadone and EDDP.
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I am between 18 and 65 years old.
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I understand the study and agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to CBD, gelatin, or sesame oil.
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My kidney function is normal and my liver tests are not significantly high.
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I am currently pregnant or breastfeeding.
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I am not using any reliable birth control methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-weeks and 8-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-weeks and 8-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
Change in Visual Analog Scale for Craving (VASC)
Proportion of participants with positive urine toxicology
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Secondary outcome measures
Change in Blood pressure
Change in Body Temperature
Change in Change in dosage of opioid agonist treatment
+22 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Methadone CBDActive Control2 Interventions
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Group II: Buprenorphine CBDActive Control2 Interventions
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Group III: Methadone PlaceboPlacebo Group2 Interventions
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Group IV: Buprenorphine PlaceboPlacebo Group2 Interventions
Matching placebo.in first dosing period and CBD 400mg in second dosing period

Find a Location

Who is running the clinical trial?

Yasmin HurdLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Yasmin Hurd, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
423 Total Patients Enrolled
~36 spots leftby Oct 2024