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

NCT ID: NCT04192370

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2021-12-30

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.

Detailed Description

Studies have indicated that medication treatment for opioid use disorder (OUD) with buprenorphine, methadone, or extended-release naltrexone reduces the risk for overdose by 70%. However, treatment dropout rates remain unacceptably high, with approximately 50% of patients discontinuing treatment 6 months after initiation. There is a substantial body of research indicating that high rates of treatment discontinuation are due to the emergence of intense cravings to use illicit opioids in response to cues - which are reminders of the drug such as drug paraphernalia. Much of the research so far in improving treatment retention on medications for OUD have focused on helping patients learn how to avoid triggers and to manage their cravings if they do emerge, and psychosocial treatments as adjuncts to medications has similarly not been as helpful as hoped. As such, there is a critical need to identify novel strategies that will improve retention in medical treatment for OUD, and cannabidiol (CBD) has emerged as a possible adjunct to OUD treatment, as it appears to target brain regions that mediate cue-induced cravings. Two studies so far have shown that CBD reduces cue-induced cravings for abstinent individuals with OUD not taking any medications, but the impact of CBD on cue-induced cravings among individuals stabilized on buprenorphine is not known.

Given that long-term medication treatment remains the gold-standard approach, a critical question that remains unanswered is whether CBD can be used as an adjunct to buprenorphine treatment to reduce cue-induced cravings. As such, the purpose of this week-long open-label feasibility pilot is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment. Patients with OUD currently receiving treatment with sublingual buprenorphine will be eligible to enroll. The cue-induced cravings assessment will be conducted before and after the CBD administration.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cannabidiol

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.

Group Type: EXPERIMENTAL

Cannabidiol 600mg

Intervention Type: 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.

Interventions

Cannabidiol 600mg

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.

Intervention Type: DRUG

Other Intervention Names

CBD; Epidiolex

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joji Suzuki, MD

Director, Division of Addiction Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joji Suzuki, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36105269 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019P003384

Identifier Type: -

Identifier Source: org_study_id