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Can cannabis compounds boost opioid addiction treatment?

NCT ID NCT07148206

Disease control Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding two FDA-approved cannabinoids—dronabinol (synthetic THC) and epidiolex (CBD)—to standard buprenorphine treatment can help people with opioid use disorder stay in treatment and reduce opioid use. The trial will enroll 40 adults who recently started buprenorphine and still have withdrawal symptoms or use other opioids. Participants will take the cannabinoids or placebos for 12 weeks, and researchers will track how many stay in treatment and test positive for buprenorphine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dronabinol (synthetic THC) and Epidiolex (CBD)
What this could lead to
If it works, this could offer a new way to help people early in opioid addiction treatment stay on track and avoid relapse.
What could go wrong
This is a small pilot study with only 40 people, so results may not apply widely. Adding cannabinoids could cause side effects or interact with buprenorphine.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Fluency in English and Spanish * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD * Newly initiated on buprenorphine within 21 days * Positive urine toxicology for opioids other than buprenorphine in the past week OR opioid withdrawal symptoms in the past week based on the Clinical Opioid Withdrawal Scale (COWS) \>=5 * Any cannabis use in the past at or after the age of 18 years based on self-report Exclusion Criteria: * Urine toxicology positive for cannabinoids * Inability to provide informed consent * Liver tests (AST or ALT) \>3 times the upper limit of normal, or a history of liver disease * Pregnancy or breast/chest feeding * Unstable cardiac disease, history of hypotension or syncope * Psychotic disorder, or history of suicidal behavior and/or ideation * Progressive neurological conditions, frequent falls, or history of epileptic seizures * Severe alcohol use disorder, benzodiazepine use disorder or stimulant use disorder * Other serious medical conditions that would be a contraindication to THC or CBD use

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Montefiore Health System (Montefiore) Buprenorphine Treatment Network

    The Bronx, New York, 10467, United States

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