CBD for Opioid Dependence and Pain on Buprenorphine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled, crossover study in outpatients with opioid use disorder on buprenorphine who also have chronic non-cancer pain. Participants will receive four CBD dose levels (400 mg, 800 mg, 1200 mg) or placebo across four experimental sessions, with sessions occurring at trough opioid levels and separated by at least 72 hours. The order of CBD and placebo is counterbalanced to reduce carryover effects, and key safety and pharmacokinetic data will be collected through blood draws and physician evaluations. The study advances over approximately four weeks and includes a screening day and a follow-up contact by phone one week after the last dose. Participants are required to be adults aged 18–70 with OUD on stable buprenorphine, chronic high-intensity non-cancer pain for at least six months, and the ability to consent in English. Exclusion criteria include other active substance use disorders (except tobacco) in the past year and medical contraindications. The investigation is conducted at a Yale-affiliated site with collaboration from VA Connecticut Healthcare System and NIDA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
* Diagnosed with OUD and currently enrolled in 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 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.
* 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.

Where it's running

• Department of Veterans Affairs Hospital
  West Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Joao De Aquino, M.D. — Yale University
• Study coordinator: Joao De Aquino, M.D.
• Email: joao.deaquinolima@yale.edu
• Phone: 203-932-5711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.