Monthly shot may boost opioid treatment success in hospitals
NCT ID NCT04345718
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a once-monthly injection of extended-release buprenorphine helps hospitalized patients with moderate to severe opioid use disorder stay in treatment better than usual care (like daily pills or methadone). Over 300 adults were randomly assigned to receive either the injection or standard medication before leaving the hospital. Researchers tracked how many were still engaged in treatment 34 days later, with follow-ups at 90 and 180 days.
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
- What this could lead to
- If successful, this could show that a monthly injection of buprenorphine helps more people stay in treatment for opioid use disorder compared to daily pills or other standard options.
- What could go wrong
- This is a completed Phase 2/3 trial, but results may not apply to all patients or settings. Extended-release buprenorphine can have side effects like injection site reactions or withdrawal symptoms.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
344 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Aug 2025
- 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
-
18 years and older
- 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: 1. Hospitalized. 2. At least 18 years of age. 3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD. 4. Willing to initiate MOUD, including buprenorphine. 5. Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: 1. Anticipated length of stay less than 24-hours as determined by the ACS 2. Affected by a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make it unsafe to participate in the study or may prevent collection of study data. This may include: 1. Disabling terminal diagnosis for which discharge from hospital is not anticipated. 2. Disabling terminal diagnosis for which hospice care is being sought. 3. Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization. 3. Taking a long-acting opioid other than buprenorphine (e.g., methadone, extended-release oxycodone, extended-release morphine) in the three consecutive days prior to randomization. 4. Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease. 5. Currently pregnant. 6. Known allergy to buprenorphine or components of Atrigel delivery system. 7. Receipt of MOUD in the 14 days prior to hospitalization as maintenance treatment; however, patients may have received MOUD for withdrawal management during or prior to hospitalization at the time of enrollment. 8. Are currently in jail, prison or other overnight facility as required by court of law and/or is considered a prisoner under local law or is under current terms of civil commitment or guardianship. 9. Previously randomized as a participant in the study - individuals may only be enrolled and randomized once.
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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
-
Boston University
Boston, Massachusetts, 02118, United States
-
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404, United States
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
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Other studies related to the condition(s) this trial covers.
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