Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine

NCT04192370 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019P003384
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration

  Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being "not at all" and 10 being "extremely." Higher scores thus mean a "worse" outcome (i.e. more intense cravings/anxiety).

  pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)

Study Arms (1)

Cannabidiol

EXPERIMENTAL

As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days.

Drug: Cannabidiol 600mg

Interventions

Cannabidiol 600mg DRUG

All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.

Also known as: CBD, Epidiolex

Cannabidiol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use disorder, severe
• Currently in treatment with methadone or buprenorphine

You may not qualify if:

• Requiring level of care higher than outpatient treatment for alcohol, sedative/hypnotics, or stimulants
• Any current mood episode requiring level of care higher than outpatient treatment
• History of psychotic disorder or bipolar disorder
• Currently pregnant
• Hepatic liver enzymes greater than 3x upper normal limit
• Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame oil emulsion)
• Currently taking any medications with known significant pharmacokinetic interactions with CBD

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Suzuki J, Martin B, Prostko S, Chai PR, Weiss RD. Cannabidiol Effect on Cue-Induced Craving for Individuals with Opioid Use Disorder Treated with Buprenorphine: A Small Proof-of-Concept Open-Label Study. Integr Med Rep. 2022 Aug 1;1(1):157-163. doi: 10.1089/imr.2022.0070. Epub 2022 Aug 26.

  PMID: 36105269 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Joji Suzuki, MD
• Organization: Brigham and Women's Hospital

Jsuzuki2@bwh.harvard.edu

617-455-7981

Study Officials

• Joji Suzuki, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: August 3, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)