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Cannabinoid

CBD for Opioid Use Disorder

Phase 2

Recruiting

Led By Yasmin Hurd, PhD

Research Sponsored by Hurd,Yasmin, Ph.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals between 18 and 65 years old

Current methadone maintenance in an opioid treatment program with a dose of =/>40mg for at least 14 days prior to participation and prescribed take-home methadone medication

Must not have

Acute opioids withdrawal symptoms (observational and determined by the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥#5 will be considered a positive result for withdrawal symptoms and/or by clinical judgement

Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives,Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 mri scans (duration 30 mins)

Awards & highlights

Summary

This trial will test if CBD can help reduce craving and anxiety in people abstaining from heroin. Brain scans will be taken before and after CBD administration to see how it affects neural circuits and transmitters.

Who is the study for?

This trial is for adults aged 18-65 with opioid use disorder, currently on methadone maintenance. Participants must have been abstinent from heroin for at least 7 days and cannot be seeking treatment for heroin addiction. They should not have other substance use disorders (except nicotine), be pregnant or breastfeeding, or have certain medical conditions that exclude them from MRI scans.

What is being tested?

The study tests the effects of CBD versus a placebo in reducing craving and anxiety in individuals with opioid use disorder on methadone. It involves neuroimaging to observe brain activity after initial and repeated doses of CBD (800mg) over a week.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to CBD administration, which could include changes in mood, appetite, drowsiness or potential interactions with their ongoing methadone treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been on methadone treatment of 40mg or more for over 14 days and have take-home doses.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing withdrawal symptoms from opioids.

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I am not using any reliable birth control methods.

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My kidney function or liver enzymes have never been more than twice the normal limit.

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I do not speak English.

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I do not have any medical or mental health conditions that would prevent me from safely taking CBD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 mri scans (duration 30 mins)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 mri scans (duration 30 mins)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 mri scans (duration 30 mins) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CBD effects on in vivo glutamatergic levels within mesocorticolimbic brain regions

Change in fMRI BOLD signal acquired during resting-state functional connectivity

Change in fMRI BOLD signal during cue reactivity

Secondary study objectives

Change in cue-induced anxiety on the VAS

Change in cue-induced drug craving on the VAS

Heart rate (in beats/min)

+1 more

Other study objectives

Adverse Events as assessed by the SAFTEE

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CBD 800mgExperimental Treatment1 Intervention

Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Group II: ControlPlacebo Group1 Intervention

Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol (CBD)

2021

Completed Phase 2

~140

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hurd,Yasmin, Ph.D.Lead Sponsor

5 Previous Clinical Trials

297 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

249 Previous Clinical Trials

34,775 Total Patients Enrolled

Yasmin Hurd, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

4 Previous Clinical Trials

463 Total Patients Enrolled

Media Library

Cannabidiol (CBD) (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04567784 — Phase 2

Opioid Use Disorder Research Study Groups: CBD 800mg, Control

Opioid Use Disorder Clinical Trial 2023: Cannabidiol (CBD) Highlights & Side Effects. Trial Name: NCT04567784 — Phase 2

Cannabidiol (CBD) (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567784 — Phase 2

~35 spots leftby Nov 2025

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