Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Opioid-use Disorder

Treatments: Drug: Cannabidiol 100 MG/ML [Epidiolex]; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04982029

2021P001829

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

Cannabidiol 600mg

Experimental group

Description:

All subjects will receive 600mg of oral cannabidiol in a double-blind fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL. Following administration, a battery of tests will be conducted to examine reward- and stress-related neurocognitive processes.

Treatment:

Drug: Cannabidiol 100 MG/ML [Epidiolex]

Placebo

Placebo Comparator group

Description:

All subjects will receive a matching placebo in a double-blind fashion. Following administration, a battery of tests will be conducted to examine the impact on reward- and stress-related neurocognitive processes.

Treatment:

Drug: Placebo