CBD could help ease pain and cravings in opioid recovery
NCT ID NCT04587791
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study at Yale tests whether cannabidiol (CBD) is safe and can reduce pain and opioid cravings in 34 adults with opioid use disorder and chronic pain. Participants are already on methadone or buprenorphine and will receive different doses of CBD or a placebo in a crossover design. The study focuses on safety, abuse potential, and effects on pain sensitivity and cognition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cannabidiol (CBD)
- What this could lead to
- If it works, this could point toward a safe way to help manage pain and reduce opioid cravings in people recovering from opioid addiction.
- What could go wrong
- This is a very early, small study with only 34 participants, so results may not apply widely. CBD may cause side effects or not improve pain or cravings at all.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Veterans Affairs Hospital
RECRUITINGWest Haven, Connecticut, 06516, United States
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