Adjunctive Cannabidiol for Recovery From Opioid Study

NCT06940674 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY-24-01494UH3DA050323
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

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)

Outcome Measures

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.

  24 weeks

Secondary Outcomes (15)

• Concentration of illicit opioids

  Duration of the trial, 24 weeks

• Weeks of abstinence

  Duration of the trial, 24 weeks

• Use of non-opioid illicit substances

  Duration of the trial, 24 weeks

• Duration of first opioid abstinence

  Duration of the trial, 24 weeks

• Cue-induced Visual Analog Scale for craving (VASC)

  At 12 and 24-week time points

Study Arms (3)

1 capsule CBD (200 mg)

EXPERIMENTAL

1 capsule 200 mg CBD 2x per day

Drug: Cannabidiol

2 capsules CBD (400 mg)

EXPERIMENTAL

2 capsules 400 mg CBD 2x per day

Drug: Cannabidiol

1 capsule placebo and 2 capsules placebo

PLACEBO COMPARATOR

1 capsule 200 mg placebo 2x per day or 2 capsules 400 mg placebo 2x per day

Drug: Placebo

Interventions

Cannabidiol DRUG

1 capsule CBD 200mg

Also known as: CBD

1 capsule CBD (200 mg); 2 capsules CBD (400 mg)

Placebo DRUG

Bovine Gel Placebo capsule

1 capsule placebo and 2 capsules placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brains Bioceutical: collaborator
• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Drug Abuse (NIDA): collaborator
• International Center for Health Outcomes and Innovation Research: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

CODA Treatment Recovery

Portland, Oregon, 97214, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Yasmin Hurd, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Spieler

CONTACT

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

Jonathan Hupf

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators and participants will be blinded to treatment assignment. The staff involved in primary outcome assessment and laboratory tests in local laboratories will also be blinded to treatment assignment. Randomization will be generated centrally and performed through a Web-based data collection system that automates the delivery of the randomization codes. The treatment assignment will be sent to the unblinded pharmacist or unblinded study team electronically, in a secure fashion, and electronic verification of the treatment assignment will be required before proceeding with the treatment intervention. Active drug and placebo will be identical to maintain study blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization will be carried out within each site using stratification factors. Using stratified block randomization with randomly varying block sizes, participants who meet the eligibility requirements and provide informed consent will be randomly allocated to one of the study arms (1 capsule CBD (200 mg), 2 capsules CBD (400 mg), 1 capsule placebo and 2 capsules placebo) with a 1:1:0.5:0.5 allocation ratio. The placebo groups will be combined for statistical analysis purposes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be shared no later than 6 months after study completion or as soon as any necessary cleaning and validation procedures are performed.
• Access Criteria: There are no major factors affecting the access, distribution or reuse of the scientific data to be generated. All research participants will be consented for broad data sharing. All data will be made publicly available once the study is completed, following the timeline outlined in Element 4. The data will be de-identified to ensure study participant confidentiality. Access to the scientific data will not be controlled other than the requirements imposed by the NDA and IRB as mentioned above. Data will be distributed via publicly accessible platforms, including the HEAL Data Commons and ClinicalTrials.gov. These repositories ensure that the data is accessible to the broader scientific community. Data reuse will be encouraged as long as it adheres to the HEAL Data Commons' data use and citation policies as well as any requirements imposed by the IRB. Data users must acknowledge the original study and its investigators in any publications or other outputs based on the shared data.

Locations

US (2)