Clinical trial NCT04982029: Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
Official title: Cannabidiol on reward-and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder: A Double-blind, Placebo-controlled, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-use Disorder
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2021-07-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a double-blind, placebo-controlled, cross-over trial.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Individuals with opioid use disorder (OUD) demonstrate reward- and stress-related neurocognitive changes compared to individuals without OUD, including cravings for opioids in response to exposure to triggers, tendency to make impulsive and disadvantageous decisions, and a strong attentional bias towards drug-related cues. Together, these deficits are significant contributors to relapse and discontinuation of treatment. Cannabidiol (CBD) has been shown to impact some of these cognitive deficits but studies of CBD among individuals with OUD are mostly lacking. Therefore, this study aims to answer whether CBD has any impact on reward-related neurocognitive deficits in individuals with OUD. If successful, this line of research will lay the groundwork for future studies to evaluate CBD's impact on OUD treatment outcomes.

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

Primary outcomes:
measure: Change in Cue-reactivity
timeFrame: Visit 2 and 3 (at least 1 week apart)
Secondary outcomes:
measure: Delayed Discount
timeFrame: Visit 2 and 3 (at least 1 week apart)
measure: Decision Making
timeFrame: Visit 2 and 3 (at least 1 week apart)
measure: Attentional Bias
timeFrame: Visit 2 and 3 (at least 1 week apart)
measure: Stress-reactivity
timeFrame: Visit 2 and 3 (at least 1 week apart)
measure: Stress-Reactivity (Physiological)
timeFrame: Visit 2 and 3 (at least 1 week apart)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rutland
country: United States
facility: Rutland Medical Center
state: Vermont
Study officials:
References: