Can a monthly shot beat daily pills for fentanyl users?

NCT ID NCT04352166

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether a monthly injection of extended-release buprenorphine (Sublocade) helps people with opioid use disorder who use fentanyl reduce their opioid use more than the standard daily sublingual buprenorphine pills. Adults aged 18 to 65 with moderate to severe opioid use disorder who test positive for high-potency synthetic opioids can join. Participants receive either three monthly injections or daily pills for 12 weeks, and researchers track how many days per week they use opioids.

What this could mean

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

Active substance
extended-release buprenorphine (Sublocade) injection compared to sublingual buprenorphine pills
What this could lead to
If the injection works better than the pills, it could offer a more reliable treatment option for people with opioid use disorder, especially those using fentanyl.
What could go wrong
This is a small, early-stage trial, so the results may not apply to everyone. The injection may not be more effective than the standard pills, and there are risks like injection site reactions or side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

Dec 2020

Finished

Aug 2023

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: * Individuals between the age of 18-65 * Voluntarily seeking treatment for opioid use * Meets current DSM-5 criteria for Opioid Use Disorder as a primary diagnosis, with at least moderate severity * Test positive for high potent synthetic opioids (HPSO) use * Able to provide informed consent and comply with study procedures Exclusion Criteria: * Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis * Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk * Methadone maintenance treatment within the past 30 days * Buprenorphine maintenance treatment within the past 30 days * Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine) * Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients; male participants are required to use adequate forms of birth control as the exposure to sublocade on sperm and subsequent fetal development are not known * Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure \>150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT \>3 times the upper limit of normal * Legally mandated to substance use disorder treatment * Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary * Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g., history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.

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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.

Contacts and locations

Locations

  • Nyspi-Stars

    New York, New York, 10019, United States

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