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Cannabidiol in the Treatment of Opioid Use Disorder

NCT ID: NCT06206291

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2024-12-04

Brief Summary

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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 our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.

Detailed Description

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In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.

Conditions

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Opioid Use Disorder

Keywords

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CBD Cannabidiol Methadone Buprenorphine Opioid Use Disorder OUD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methadone CBD

CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.

Group Type ACTIVE_COMPARATOR

Cannabidiol (CBD) 200mg

Intervention Type DRUG

First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.

Cannabidiol (CBD) 400mg

Intervention Type DRUG

Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Methadone Placebo

Matching placebo.in first dosing period and CBD 400mg in second dosing period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo twice daily for first 4 weeks

Cannabidiol (CBD) 400mg

Intervention Type DRUG

Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Buprenorphine CBD

CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.

Group Type ACTIVE_COMPARATOR

Cannabidiol (CBD) 200mg

Intervention Type DRUG

First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.

Cannabidiol (CBD) 400mg

Intervention Type DRUG

Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Buprenorphine Placebo

Matching placebo.in first dosing period and CBD 400mg in second dosing period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo twice daily for first 4 weeks

Cannabidiol (CBD) 400mg

Intervention Type DRUG

Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Interventions

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Placebo

Matching placebo twice daily for first 4 weeks

Intervention Type DRUG

Cannabidiol (CBD) 200mg

First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.

Intervention Type DRUG

Cannabidiol (CBD) 400mg

Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

An individual who meets all of the following criteria will be eligible for study participation:

* 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 in an opioid treatment program with methadone or buprenorphine for at least 14 days prior to study participation. With the following more specific criteria for each of these two medications:

* Current methadone maintenance treatment with a dose of ≥ 40mg/day, (maximum: 200mg/day), AND urinary toxicology positive for methadone and EDDP; OR
* Current buprenorphine maintenance treatment with a dose of ≥ 8mg/day (maximum: 24mg/day), AND urinary toxicology positive for buprenorphine.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation:

* 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 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.
* Alcohol intoxication when arriving at the study site (i.e., positive alcohol breathalyzer / alcohol salivary strips / urine alcohol).
* 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:

* History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: \>4x the upper limit of normal (ULN) per laboratory criteria for AST or ALT, \>1.5x ULN for bilirubin or \<30mL/min/1.73m2 eGFR
* QTc Frederica \> 500ms
* Participating in another pharmacotherapeutic trial in the past 3 months.
* Participants who have used any medication, 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, etc.) 14 days prior to and during the duration of the study
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yasmin Hurd

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Hurd

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yasmin Hurd, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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GCO# 21-0663

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY-21-00607

Identifier Type: -

Identifier Source: org_study_id