Can a Cannabis-Derived drug ease pain without raising opioid risks?
NCT ID NCT04025359
First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This early-phase trial at Yale tests whether dronabinol (Marinol), a synthetic form of THC, can reduce pain sensitivity and improve attention and mood in 36 adults with opioid use disorder who are stable on methadone or buprenorphine. Participants receive either 2.5 mg, 5 mg of dronabinol, or a placebo before their daily opioid dose. The study measures pain via cold and heat tests, questionnaires, and cognitive tasks, with a one-week follow-up for safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dronabinol (Marinol)
- What this could lead to
- If it works, this could point toward a way to manage pain in people on opioid maintenance therapy without increasing opioid use.
- What could go wrong
- This is a very small, early-phase study with only 36 participants, so results may not apply broadly. Dronabinol can cause side effects like dizziness or confusion.
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 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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Jan 2027
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: * Prior exposure to THC or cannabis at least once in the last 10 years; 1-10 times in the last 20 years; or more than 20 times in their lifetime. * Males and females, Veterans and non-Veterans, aged between 18 and 70. * Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment. * 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: * Currently meeting DSM-5 criteria for cannabis use disorder (CUD). * History of primary psychotic disorders or other current major psychiatric disorders deemed clinically unstable by the principal investigator. * Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator. * Inability to complete neuropsychological tests. * 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), tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, tegretol), benzodiazepines (e.g., alprazolam, diazepam), and other opioid drugs). Only subjects who are on stable doses of these medications, and whose dosing schedules allow participation in the study visits, will be enrolled. If possible, the morning dose will be administered after the study visit. * Liver function tests (ALT or AST) greater than 3x normal. * Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension. * Allergy or serious adverse reaction to cannabis, dronabinol or other cannabinoids.
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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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VA Connecticut Healthcare System
RECRUITINGWest Haven, Connecticut, 06516, United States
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