Phase 2
N=8
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04192370 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration — 3.2; 0.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cannabidiol 600mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration |
3.2; 0.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04192370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.