NCT05076370

Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine

Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving methadone or buprenorphine.

Detailed description

An initial safety pilot phase will recruit six participants: three receiving treatment with methadone and three receiving treatment with buprenorphine. If the results of the pilot study support the safety of CBD administration in this clinical sample, the general study will recruit participants with comorbid OUD and chronic pain, with half the subjects receiving methadone and half receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.

Conditions

• Addiction

Interventions

Type	Name	Description
DRUG	CBD Day 1	CBD 400mg
DRUG	CBD Day 2	CBD 800mg
DRUG	CBD Day 3	CBD 1200mg

Timeline

• Start date: 2021-12-08
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2021-10-13
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study