Adjunctive Cannabidiol for Recovery From Opioid Study

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06940674
Phase
PHASE3
Status
Recruiting
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Conditions

  • Opioid Use Disorder (OUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol — DRUG
    1 capsule CBD 200mg
  • Placebo — DRUG
    Bovine Gel Placebo capsule

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Dec 2025
Primary completion
Jul 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 capsule CBD (200 mg)
    1 capsule 200 mg CBD 2x per day
  • Experimental: 2 capsules CBD (400 mg)
    2 capsules 400 mg CBD 2x per day
  • Placebo Comparator: 1 capsule placebo and 2 capsules placebo
    1 capsule 200 mg placebo 2x per day or 2 capsules 400 mg placebo 2x per day

Primary Outcome Measure

Percentage of study participants with negative urine toxicology for illicit opioid use [ Time Frame: 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Ashanta Carter
[email protected]
212-585-4653
Yasmin Hurd (PRINCIPAL_INVESTIGATOR)
CODA Treatment RecoveryPortlandOregon97214
Hannah Lemons
[email protected]
Tara Chowdhury (PRINCIPAL_INVESTIGATOR)

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