CBD for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
The investigators propose an imaging study to investigate the neurobiological effects of CBD (vs placebo) in participants with opioid use disorder who are maintained on methadone. The purpose of the study is to determine the neural circuits and transmitters associated with the effects of CBD on to reduce craving and anxiety. The neuroimaging will be conducted in participants immediately following their first administration of CBD (800mg or placebo) and one week after the last administration (3 daily doses). This CBD administration protocol was shown in previous studies by the investigators to reduce craving and anxiety in abstinent heroin users.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of methadone for at least 14 days before participating.
Is CBD safe for humans?
How does the drug CBD differ from other treatments for opioid use disorder?
CBD is unique because it is a non-psychoactive component of cannabis that may help reduce the rewarding effects of addictive drugs like opioids, without causing a high or dependence. Unlike traditional treatments, CBD has a low potential for abuse and is being explored for its ability to safely manage substance use disorders.12367
What data supports the effectiveness of the drug Cannabidiol (CBD) for Opioid Use Disorder?
Preliminary studies suggest that CBD may help reduce cravings and stress-related responses in people with opioid use disorder, potentially supporting its use alongside other treatments. Additionally, CBD has shown promise in reducing cravings for other substances, like cocaine, which may indicate its potential effectiveness for opioid use disorder.23489
Who Is on the Research Team?
Yasmin Hurd
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CBD or placebo for 3 daily doses with neuroimaging conducted immediately after the first dose and one week after the last dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and changes in craving and anxiety
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol (CBD)
- Placebo
Cannabidiol (CBD) is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hurd,Yasmin, Ph.D.
Lead Sponsor
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland