Cannabidiol in the Treatment of Opioid Use Disorder

NCT06206291 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY-21-00607GCO# 21-0663
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Opioid Use Disorder

Keywords

CBD; Cannabidiol; Methadone; Buprenorphine; Opioid Use Disorder; OUD

Outcome Measures

Primary Outcomes (4)

• Change in Visual Analog Scale for Craving (VASC)

  Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.

  Baseline and 4 weeks

• Change in Visual Analog Scale Anxiety (VASA)

  Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.

  Baseline and 4-weeks

• Proportion of participants with positive urine toxicology

  Proportion of participants with positive urine toxicology for illicit opioid use at 4 weeks.

  4-weeks

• Systematic Assessment for Treatment Emergent Events (SAFTEE)

  Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.

  weekly for 8 weeks

Secondary Outcomes (36)

• Change in Visual Analog Scale for craving (VASC)

  baseline and 4-weeks

• Change in Visual Analog Scale for craving (VASC)

  4-weeks and 8-weeks

• Change in Visual Analog Scale Anxiety (VASA)

  baseline and 4-weeks

• Change in Visual Analog Scale Anxiety (VASA)

  4-weeks and 8-weeks

• Change in proportion of participants with positive urine toxicology

  4 weeks and 8 weeks

Study Arms (4)

Methadone CBD

ACTIVE COMPARATOR

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

Drug: Cannabidiol (CBD) 200mg; Drug: Cannabidiol (CBD) 400mg

Methadone Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Cannabidiol (CBD) 400mg

Buprenorphine CBD

ACTIVE COMPARATOR

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

Drug: Cannabidiol (CBD) 200mg; Drug: Cannabidiol (CBD) 400mg

Buprenorphine Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Cannabidiol (CBD) 400mg

Interventions

Placebo DRUG

Matching placebo twice daily for first 4 weeks

Buprenorphine Placebo; Methadone Placebo

Cannabidiol (CBD) 200mg DRUG

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

Buprenorphine CBD; Methadone CBD

Cannabidiol (CBD) 400mg DRUG

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

Buprenorphine CBD; Buprenorphine Placebo; Methadone CBD; Methadone 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:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Yasmin Hurd: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: October 4, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)