Cannabidiol in Opioid Use Disorder and Chronic Pain

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

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2026-03-31

Brief Summary

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This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 4 weeks, during which participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, Cannabidiol (CBD) will be administered, separated by at least 72 hours to limit carryover effects.

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Detailed Description

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Thirty-six male and female (ages 18-70) participants with comorbid opioid use disorder (OUD) and non-cancer chronic pain for at least 6 months, currently receiving methadone (n= 22) or buprenorphine (n= 12), will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive oral CBD (400 mg, 800 mg, 1200 mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes.

Pain sensitivity will be measures including the well-validated, Quantitative Sensory Testing (QST), the Pain Catastrophizing Scale (PCS), and a pain Visual Analog Scale (VAS). Attentional bias and cue-induced opioid craving will be measured using a visual probe task and the Heroin Craving Scale (HCQ-14). Abuse potential will be measured using the Drug Effects Questionnaire (DEQ). Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery that includes the Continuous Performance Test (CPT) and the Hopkins Verbal Learning Test (HVLT). Safety will be thoroughly measured with the Systematic Assessment for Treatment Emergent Events (SAFTEE) for adverse effects.

The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum drug levels. Participants will be thoroughly evaluated by a physician prior to discharge on each experimental session. One week after the last study medication dose, participants will be conducted by phone for a follow-up session.

Conditions

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Chronic Pain Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.

Study Groups

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CBD 400mg

CBD 400 mg

Group Type ACTIVE_COMPARATOR

400mg Cannabidiol

Intervention Type DRUG

Participants will receive 400mg

CBD 800mg

Group Type ACTIVE_COMPARATOR

800mg Cannabidiol

Intervention Type DRUG

Participants will receive 800mg

CBD 1200mg

Group Type ACTIVE_COMPARATOR

1200mg Cannabidiol

Intervention Type DRUG

Participants will receive 1200mg

Saline

saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Participants will receive saline

Interventions

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400mg Cannabidiol

Participants will receive 400mg

Intervention Type DRUG

800mg Cannabidiol

Participants will receive 800mg

Intervention Type DRUG

1200mg Cannabidiol

Participants will receive 1200mg

Intervention Type DRUG

Saline

Participants will receive saline

Intervention Type DRUG

Other Intervention Names

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CBD CBD CBD placebo

Eligibility Criteria

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Inclusion Criteria

* Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
* Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
* Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months 49
* Capable of providing informed consent in English.
* Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
* Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
* No current medical problems deemed contraindicated for participation by principal investigator.
* For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.

Exclusion Criteria

* Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
* Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
* Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
* A study physician will determine if participants receiving products containing THC or CBD products may participate in the study.
* Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
* Current weight of less of 60 kg.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No