Adjunctive Cannabidiol for Recovery From Opioid Study

Recruiting Phase 3 Interventional Study
Opioid Use Disorder (OUD)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
450 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
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About This Trial
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 this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD; Brains Bioceutical). The second phase was a double-blinded randomized controlled t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Individuals between 18 and 65 years old. * Ability to understand and give informed consent. * Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric In…
Contacts

Zoe Spieler

929-923-3216

Zoe.Spieler@mountsinai.org

CONTACT

Jonathan Hupf

646-385-0854

Jonathan.Hupf@mountsinai.org

CONTACT