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Cannabidiol for Opioid Use Disorder and Chronic Pain

This study is testing whether different doses of Cannabidiol (CBD) can help people with opioid use disorder (OUD) and chronic pain. You might be able to join if you are between 18 and 70 years old, have OUD and are currently on methadone or buprenorphine treatment, and also have chronic pain that has lasted at least 6 months. The study will look at how safe CBD is, if it has any potential for abuse, and how it affects your thinking. Researchers will also measure its effects on pain and opioid cravings. The study is currently unclear on its recruitment status and plans to enroll 34 participants.

Study design
This is a randomized, placebo-controlled, crossover study, meaning participants will receive different doses of Cannabidiol (400 mg, 800 mg, 1200 mg) and a placebo (beta carotene oral solution without CBD) at different times. It plans to enroll 34 participants.
What's involved
You would participate for approximately 4 weeks, attending one initial screening session and four experimental sessions where study medication will be given. These sessions will be separated by at least 72 hours.
Compensation
Not stated in the trial record.
Follow-up
Safety and abuse potential are measured up to 240 minutes after CBD administration, and cognitive effects are measured at 210 minutes after administration.

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

NCT04587791

Cannabidiol in Opioid Use Disorder and Chronic Pain

Recruiting
EARLY_PHASE1Ages 18–70InterventionalTreatment
Yale University
~34 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:400 mg Cannabidiol800 mg Cannabidiol1200 mg CannabidiolBeta carotene oral solution without CBD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Measured over Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD
+3 more outcomes measured

Conditions

Chronic Pain
Opioid Use Disorder

Explore related trials

Chronic PainOpioid Use Disorder

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Joao De Aquino, M.D. · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Joao De Aquino, M.D.
[email protected]
203-932-5711 · ext. 12916
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 pain for ≥ 6 months.
Capable of providing informed consent in English.
Compliant in opioid maintenance treatment and on a stable dose for four 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. Acceptable contraception for females includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception methods.

Exclusion

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.
Methadone dose under 30 mg or over 150 mg/day.
Buprenorphine dose over 24 mg per day.
Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
Candidates receiving products containing either THC or CBD will be excluded. All participants will be asked to abstain from cannabinoids. Prior to receiving the study medication on the first test session, participants' cannabinoid use will be assessed using a quantitative point-of-care urine 11-nor-9-carboxy-THC concentration test with a cut-off of ≤ 50 mg/mL. If a participant tests greater than ≤50 mg/mL, they will be asked to abstain for an additional 7 to 14 days. If 14 days after their initial THC concentration test the participant continues to test positive, they will not be allowed to participate in the study.
A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), gabapentinoids, tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, carbamazepine)). Only participants who are on stable doses (i.e., consistent daily administration of the medication for at least three months at the same dose following the last dose change, either increase or decrease) of these medications, and whose dosing schedules allow participation in the study visits, thus excluding instances of single-dose or temporary dosing of the medication, will be eligible as determined by principal investigator. If possible, the morning dose will be administered after the study visit.
Current, regular use of benzodiazepines, other prescription opioids, or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
Current weight of less of 60 kg.
Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.
Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.
Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension.

What this trial measures

  • Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE)Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD

    The SAFTEE is a multi-symptom checklist that has been used successfully in the investigators previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE is administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4 hours after the administration of CBD (timepoint +240 minutes) during each test session. Data will be presented as the number of participants that reported symptoms on the SAFTEE.

  • Abuse potential of CBD measured by the Drug Effects Questionnaire (DEQ)Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)

    The DEQ will be administered to assess the abuse potential of CBD. The DEQ is a 10-item questionnaire used to assess the subjective effects of psychoactive drugs. Each item is a visual analogue scale (VAS) ranging from 0-100. The questionnaire is used to measure whether a subject feels the drug "feels high", likes or dislikes the effects, and whether they want more of the drug. The primary DEQ outcome will be the Stimulatory Effects subscale, obtained by averaging participants responses to the items: "Feel High"; "Feel Stimulated"; and "Feel the Drug Strength".

  • Cognitive effects of CBD measured by the Hopkins Verbal Learning Test (HVLT)+210 minutes after the administration of CBD

    The HVLT will be used to assess the cognitive effects of CBD. The primary outcomes will be immediate and delayed recall, which index verbal memory. The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The participant is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The participants' free recall of the list is recorded. The same procedure is repeated for two more trials (immediate recall). After approximately 15 minutes the participant will be asked to recall as many words from the list as they can without the list being re-read to them (delayed recall).

  • Cognitive/psychomotor effects of CBD measured by the Continuous Performance Test (CPT)+210 minutes after the administration of CBD

    The cognitive/psychomotor effects of CBD will be assessed using the Continuous Performance Test (CPT). CPT is a computerized neuropsychological assessment that measures participants sustained and selective attention. For the CPT, the primary outcome will be the throughput score, which indexes attention/working memory accuracy (i.e. percent of correct responses) and speed (i.e. reaction time).