Recruiting
Phase 3

Cannabidiol

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06940674

Conditions

Opioid Use Disorder (OUD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Placebo

Study Details

Brief 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 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.

Conditions

Opioid Use Disorder (OUD)

Study ID

NCT06940674

Start date

Jun 13, 2025

Status verified date

Dec, 2025

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Interview).
  • Current opioid agonist maintenance treatment with methadone or buprenorphine for at least 14 days prior to consent. With the following more specific criteria for each of these two medications:

  • 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).
  • Current buprenorphine maintenance treatment with a dose of ≥ 2mg/day (maximum: 32mg/day), AND urinary toxicology positive for buprenorphine.

Exclusion Criteria:

  • 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.
  • Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil).
  • Showing signs of acute opioid withdrawal symptoms (as determined by the result of the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥ 5 or as interpreted by the investigator will be considered a positive result for withdrawal symptoms).
  • Have a medical condition that would make study participation unsafe, which would make treatment compliance difficult, or would prevent adherence to study procedure. This includes but is not limited to the following criteria: • < 30mL/min/1.73m2 eGFR. •QTc Fridericia > 500ms at screening. •Elevated liver enzymes at screening. The exclusionary lab values are: >4x the upper limit of normal (ULN) per laboratory criteria for AST or ALT or >1.5x ULN for bilirubin.
  • Participating in another pharmacotherapeutic trial in the past 3 months.
  • Participants who have used (within 14 days prior to consent) or plan to use (during the 24-week treatment period) any medications, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (buproprion, rifampin, barbiturates, phenothiazines, cimetidine, anticoagulants, antiplatelets, etc.).
  • For women: being pregnant (positive urine test for pregnancy) or breastfeeding.
  • Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm).
  • Participants who have been court mandated to attend treatment centers

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Cannabidiol

1 capsule CBD 200mg

Placebo

Bovine Gel Placebo capsule

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Zoe Spieler

929-923-3216Zoe.Spieler@mountsinai.org

Jonathan Hupf

646-385-0854Jonathan.Hupf@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Ashanta Carter

212-585-4653ashanta.carter@mssm.edu

Principal Investigator:

Yasmin Hurd

CODA Treatment Recovery

Recruiting

Portland, Oregon, United States, 97214

Contacts

Hannah Lemons

HannahLemons@codainc.org

Principal Investigator:

Tara Chowdhury

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-12-11.