Safety of Cannabidiol Given to Subject With Methadone or Buprenorphine – Full Text View

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ClinicalTrials.gov Identifier: NCT05076370
Recruitment Status

Sponsor:

Information provided by (Responsible Party):

Joao De Aquino, Yale University

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Brief 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 medication-assisted treatment (MAT) with methadone or buprenorphine.








Addiction

Drug: CBD Day 1
Drug: CBD Day 2
Drug: CBD Day 3

Early Phase 1

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 48 participants with comorbid OUD and chronic pain, for a total of 24 completers – 12 subjects (6 men and 6 women) receiving methadone and 12 subjects (6 men and 6 women) receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.

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Layout table for study information



Study Type

Interventional
 (Clinical Trial)

Estimated
Enrollment
6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Initial safety pilot phase of 6 participants,(3 methadone and 3 on Buprenorphine) The general study 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 medication-assisted treatment (MAT) with methadone or buprenorphine.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain
Actual Study Start Date June 30, 2021
Estimated Primary Completion Date June 30, 2022
Estimated Study Completion Date August 31, 2022

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Active Comparator: CBD 400mg

CBD 400mg


Drug: CBD Day 1

CBD 400mg


Active Comparator: CBD 800mg

CBD 800mg


Drug: CBD Day 2

CBD 800mg


Active Comparator: CBD 1200mg

CBD 1200mg


Drug: CBD Day 3

CBD 1200mg


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Primary Outcome Measures