Phase 2
N=15
Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04982029 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in Cue-reactivity — 0.7; 1.1; 0.9; 2.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cannabidiol 100 MG/ML [Epidiolex] (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cue-reactivity |
0.7; 1.1; 0.9; 2.4; 0.5; 1.1 | — |
| SECONDARY Delayed Discount |
0.020; 0.039 | — |
| SECONDARY Decision Making |
2.2; -6.4 | — |
| SECONDARY Attentional Bias |
-80.4; 100.3; 145.2; -93.1 | — |
| SECONDARY Stress-reactivity |
59.00; 99.83 | — |
| SECONDARY Stress-Reactivity (Physiological) |
0.0855; 0.1542; 0.0745; 0.0816; 0.0828; 0.0806 | — |
Summary
The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.
Eligibility Criteria
Inclusion Criteria
- English speaking
- DSM5 diagnosis of opioid use disorder
- Receiving buprenorphine or methadone for treatment of opioid use disorder
- Agreeable to abstaining from using any cannabis or CBD products for the duration of the trial.
Exclusion Criteria
- Any self-reported use of cannabis or CBD products in the past 30 days
- Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10
- Currently pregnant
- Hepatic liver enzymes greater than 3x upper normal limit
- Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil emulsion)
- Currently taking any medications with known significant pharmacokinetic interactions with CBD
Data sourced from ClinicalTrials.gov (NCT04982029). 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.