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

Opioid-use Disorder Clinical Trial

— CURB  

Official title:

A Single-arm, Open-label Feasibility Pilot of Cannabidiol as an Adjunct to Sublingual Buprenorphine on Cue-induced Cravings Among Individuals With Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192370
• Other study ID #: 2019P003384
• Status: Completed
• Phase: Phase 2
• Start date: August 3, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)