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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06206291
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Ruthie Perez
Phone 212-585-4696
Email ruthie.perez@mssm.edu
Status Recruiting
Phase Phase 2
Start date October 4, 2023
Completion date October 2024

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