Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Cannabidiol 600mg
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): CBD; Epidiolex
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment