NCT06206291

Cannabidiol in the Treatment of Opioid Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Yasmin Hurd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.

Detailed description

In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo twice daily for first 4 weeks
DRUG	Cannabidiol (CBD) 200mg	First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
DRUG	Cannabidiol (CBD) 400mg	Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2024-01-16
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study