Can a monthly shot beat daily pills for fentanyl users?
NCT ID NCT04352166
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 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: * 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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