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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Opioid-use Disorder

Treatments: Drug: Cannabidiol 600mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04192370

2019P003384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Cannabidiol

Experimental group

Description:

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.

Treatment:

Drug: Cannabidiol 600mg