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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 mri scans (duration 30 mins)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,199 Total Patients Enrolled
Hurd,Yasmin, Ph.D.Lead Sponsor
5 Previous Clinical Trials
297 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: Control, CBD 800mg
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavour currently accept participants?

"As of August 29th 2022, this clinical trial has ceased recruiting participants. Initially posted on November 12th 2020, the study is now inactive; nonetheless, there are still 1341 opioid abuse studies and 79 Cannabidiol (CBD) trials accepting patients."

Answered by AI

How many participants are eligible for this trial?

"This trial is no longer enrolling participants, having first been posted on November 12th 2020 and last edited on August 29th 2022. As an alternative, there are 1341 trials for opioid abuse and 79 studies involving Cannabidiol (CBD) which are still recruiting patients."

Answered by AI

What aims are scientists hoping to achieve through this clinical trial?

"This clinical trial will assess its primary outcome, a change in fMRI BOLD signal during restful connectivity, over two 30-minute MRI scans. Secondary objectives include assessing changes to cue-induced drug cravings (measured on the Visual Analogue Scale for Craving), Clinical Opiate Withdrawal Scores and anxiety levels (also measured using VAS) about 10 days after enrolling."

Answered by AI

What are the eligibility requirements to take part in this research?

"This clinical trial is aimed at individuals who are afflicted with opioid abuse, and have an age between 18-65. An approximate of 200 patients will be accepted into this study."

Answered by AI

What further studies have been conducted using Cannabidiol (CBD) as a basis?

"Presently, a total of 79 separate clinical trials are being conducted with 16 reaching Phase 3. These studies span across 290 locations worldwide yet the majority is centered around Ribeirao Preto in Sao Paulo."

Answered by AI

Has the U.S. Food and Drug Administration granted clearance to Cannabidiol (CBD)?

"We rate Cannabidiol's safety at a 2, as there is evidence to suggest it has passed the initial testing phase but efficacy still needs to be proven."

Answered by AI

Is the age range for this clinical trial inclusive of those over 35 years old?

"The requirements for accepting participants into this medical study are that they must be between 18 and 65 years of age."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~51 spots leftby Nov 2025