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New study tests monthly shot to help people stop using fentanyl

NCT ID NCT06726200

Disease control Sponsor: Rachel R. Luba Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a once-monthly injection of buprenorphine to daily sublingual buprenorphine for treating opioid use disorder in people who use fentanyl or other strong synthetic opioids. About 60 adults aged 18–65 will be enrolled and followed for 4 weeks after starting treatment. The goal is to see which approach leads to more days without drug use and fewer relapses.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

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

Started

Feb 2026

Expected to finish

Jan 2029

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 to 65 years

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: * Aged 18 to 65 * Voluntarily seeking treatment for opioid use disorder (OUD) * Consistent use of fentanyl or other high potency synthetic opioids * Meets DSM-5 criteria for OUD with at least moderate severity * Able to provide written informed consent in English and willing to comply with study procedures Exclusion Criteria: * Meets DSM-5 criteria for another substance use disorder as the primary diagnosis * Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode) * Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis) * Buprenorphine or methadone treatment in the past 30 days * Known allergy, hypersensitivity or intolerance to buprenorphine * Pregnancy, lactation, or unwillingness to use adequate contraceptive methods * Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification * Liver function tests \> 2x the upper limit of normal * Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days

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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

  • Substance Treatment and Research Service

    RECRUITING

    New York, New York, 10019, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.