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Monthly shot may boost opioid treatment success in hospitals

NCT ID NCT04345718

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Aug 2021

Finished

Aug 2025

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: 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

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

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