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

NCT04982029 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2021P001829
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Cue-reactivity

  The primary outcomes is cue-induced cravings (Opioid Craving Scale). This was measured with a single 10-point likert scale asking about cravings, where 0 represented lower levels of craving and 10 indicated higher levels of cravings. This was given at 3 different time points, pre-cue, post-neutral, and post-drug images. Cue-induced craving is the difference between drug cue and pre-cue scores.

  Visit 2 and 3 (at least 1 week apart)

Secondary Outcomes (5)

• Delayed Discount

  Visit 2 and 3 (at least 1 week apart)

• Decision Making

  Visit 2 and 3 (at least 1 week apart)

• Attentional Bias

  Visit 2 and 3 (at least 1 week apart)

• Stress-reactivity

  Visit 2 and 3 (at least 1 week apart)

• Stress-Reactivity (Physiological)

  Visit 2 and 3 (at least 1 week apart)

Study Arms (2)

Cannabidiol 600mg

EXPERIMENTAL

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.

Drug: Cannabidiol 100 MG/ML [Epidiolex]

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Cannabidiol 100 MG/ML [Epidiolex] DRUG

600mg

Cannabidiol 600mg

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Rutland Medical Center

Rutland, Vermont, 05701, United States

Location

Related Publications (1)

• Suzuki J, Prostko S, Szpak V, Chai PR, Spagnolo PA, Tenenbaum RE, Ahmed S, Weiss RD. Impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder: A pilot, double-blind, placebo-controlled, randomized cross-over trial. Front Psychiatry. 2023 Mar 30;14:1155984. doi: 10.3389/fpsyt.2023.1155984. eCollection 2023.

  PMID: 37065899 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Joji Suzuki
• Organization: Brigham and Women's Hospital

jsuzuki2@bwh.harvard.edu

617-455-7981

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind cross-over trial, in which the research staff and participants will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Model Details: The study is a double-blind, placebo-controlled, cross-over trial.

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: July 29, 2021
• Study Start: April 14, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)