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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cannabidiol
Drug1 capsule CBD 200mg
Placebo
DrugBovine Gel Placebo capsule
Treatment groups
450 Participants
are divided into 3 treatment groupsGroup A: 1 capsule CBD (200 mg)Experimental treatment 1 intervention
Group B: 2 capsules CBD (400 mg)Experimental treatment 1 intervention
Group C: 1 capsule placebo and 2 capsules placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of study participants with negative urine toxicology for illicit opioid use
Percentage of study participants with negative urine toxicology for illicit opioid use over the course of 24 weeks.
Time frame
24 weeksSecondary outcomes
1
Concentration of illicit opioids
Concentration of illicit opioids in quantitative plasma toxicology (plasma every four weeks)
Time frame
Duration of the trial, 24 weeks2
Weeks of abstinence
Weeks of abstinence of illicit opioid use
Time frame
Duration of the trial, 24 weeks3
Use of non-opioid illicit substances
Number of weeks using other non-opioid illicit substances
Time frame
Duration of the trial, 24 weeks4
Duration of first opioid abstinence
Duration of first opioid abstinence, defined as the number of weeks from randomization to first opioid test positive or urine test missed.
Time frame
Duration of the trial, 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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