Adjunctive Cannabidiol for Recovery From Opioid Study
ConditionOpioid Use Disorder (OUD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIcahn School of Medicine at Mount Sinai
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 trial to determine whether CBD reduces craving and anxiety in individuals with OUD maintained on opioid agonist therapy. This phase 3 trial will determine whether CBD can serve as a potential adjunct treatment to reduce illicit opioid use in individuals with OUD maintained on opioid agonist therapy.
Eligibility criteria
Qualifiers
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 Interview).
Current methadone maintenance treatment with a dose of ≥ 10mg/day, (maximum: 250mg/day), AND urinary toxicology positive for methadone and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP).
Disqualifiers
Participants who are non-English speaking.
Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe, or which would prevent adherence to study procedure; examples include: suicidal (i.e. high risk for suicide on the Columbia suicide severity rating scale (C-SSRS) screen version) or homicidal ideation requiring immediate attention, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder).
Current diagnosis of a severe substance use disorder (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
Signs of acute drug intoxication when arriving at the study site as determined by clinician assessment.
Trial design
Treatments tested in this trial
- Cannabidiol
- Placebo
Treatment groups
450 Participants
are divided into 3 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
International Center for Health Outcomes and Innovation Research
Collaborator
Brains Bioceutical
Collaborator
Source ClinicalTrials.gov