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Adjunctive Cannabidiol for Opioid Use Disorder Recovery

This study is looking at whether cannabidiol (CBD), a non-intoxicating compound from the cannabis plant, can help people with opioid use disorder (OUD) reduce their illicit opioid use. Researchers want to see if CBD can be a helpful addition to standard treatments like methadone or buprenorphine. You might be able to join if you are between 18 and 65 years old and have opioid use disorder, or are in remission while on maintenance therapy. Participants will receive either 200mg of CBD or a placebo (an inactive capsule). The main goal is to see what percentage of participants have negative urine tests for illicit opioid use after 24 weeks. The current recruitment status for this study is unclear.

Study design
This is a Phase 3 interventional study that plans to enroll 450 participants. It is a double-blinded randomized controlled trial, meaning neither you nor your doctor will know if you are receiving CBD or the placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 weeks, which suggests participants will be followed for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06940674

Adjunctive Cannabidiol for Recovery From Opioid Study

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~450 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:CannabidiolPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of study participants with negative urine toxicology for illicit opioid use
Measured over 24 weeks

Conditions

Opioid Use Disorder (OUD)

Explore related trials

Opioid Use Disorder

Where it's being run

2 sites across 2 states
New York1
Oregon1

Study leadership

  • Yasmin Hurd, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Zoe Spieler
[email protected]
929-923-3216
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).
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

What this trial measures

  • Percentage of study participants with negative urine toxicology for illicit opioid use24 weeks

    Percentage of study participants with negative urine toxicology for illicit opioid use over the course of 24 weeks.