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Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04982029
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : July 22, 2022
Sponsor:
Collaborator:
Harvard Medical School (HMS and HSDM)
Information provided by (Responsible Party):
Joji Suzuki, MD, Brigham and Women's Hospital

Brief Summary:
The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Cannabidiol 100 MG/ML [Epidiolex] Drug: Placebo Phase 2

Detailed Description:
Individuals with opioid use disorder (OUD) demonstrate reward- and stress-related neurocognitive changes compared to individuals without OUD, including cravings for opioids in response to exposure to triggers, tendency to make impulsive and disadvantageous decisions, and a strong attentional bias towards drug-related cues. Together, these deficits are significant contributors to relapse and discontinuation of treatment. Cannabidiol (CBD) has been shown to impact some of these cognitive deficits but studies of CBD among individuals with OUD are mostly lacking. Therefore, this study aims to answer whether CBD has any impact on reward-related neurocognitive deficits in individuals with OUD. If successful, this line of research will lay the groundwork for future studies to evaluate CBD's impact on OUD treatment outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study is a double-blind, placebo-controlled, cross-over trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind cross-over trial, in which the research staff and participants will be blinded.
Primary Purpose: Treatment
Official Title: Cannabidiol on reward-and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder: A Double-blind, Placebo-controlled, Cross-over Trial
Actual Study Start Date : April 14, 2022
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Cannabidiol 600mg
All subjects will receive 600mg of oral cannabidiol in a double-blind fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL. Following administration, a battery of tests will be conducted to examine reward- and stress-related neurocognitive processes.
Drug: Cannabidiol 100 MG/ML [Epidiolex]
600mg

Placebo Comparator: Placebo
All subjects will receive a matching placebo in a double-blind fashion. Following administration, a battery of tests will be conducted to examine the impact on reward- and stress-related neurocognitive processes.
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Change in Cue-reactivity [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]
    The primary outcomes is cue-induced cravings (Opioid Craving Scale).


Secondary Outcome Measures :
  1. Change in Delayed discount [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]
    Monetary Choice Questionnaire will be used to calculate impulse decision making.

  2. Change in Decision making [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]
    Iowa Gambling Task will be used to assess impulsive decision-making.

  3. Change in Attentional bias [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]
    Visual probe task will be used to assess attentional bias to drug-related cues.

  4. Change in Stress-reactivity [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]
    Physiologic and subjective stress will be assessed.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • English speaking
  • DSM5 diagnosis of opioid use disorder
  • Receiving buprenorphine or methadone for treatment of opioid use disorder
  • Agreeable to abstaining from using any cannabis or CBD products for the duration of the trial.

Exclusion Criteria:

  • Any self-reported use of cannabis or CBD products in the past 30 days
  • Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10
  • Currently pregnant
  • Hepatic liver enzymes greater than 3x upper normal limit
  • Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil emulsion)
  • Currently taking any medications with known significant pharmacokinetic interactions with CBD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982029


Contacts
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Contact: Joji Suzuki, MD 617-732-5752 jsuzuki2@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joji Suzuki, MD         
Principal Investigator: Joji Suzuki, MD         
United States, Vermont
Rutland Medical Center Recruiting
Rutland, Vermont, United States, 05701
Contact: Saeed Ahmed, MD    802-775-7111    sahmed@RRMC.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
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Responsible Party: Joji Suzuki, MD, Director, Division of Addiction Psychiatry, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04982029    
Other Study ID Numbers: 2021P001829
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cannabidiol
Anticonvulsants