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Jail-to-Community opioid treatment: monthly shot vs. daily pill

NCT ID NCT06306443

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a monthly extended-release buprenorphine injection works better than daily sublingual tablets for adults with opioid use disorder who are about to be released from jail. 240 participants will be randomly assigned to one of the two treatments while still incarcerated and followed for 12 months after release. The goal is to see which approach reduces opioid relapse and keeps people in treatment longer.

What this could mean

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

Active substance
buprenorphine (extended-release injection and sublingual tablet)
What this could lead to
If it works, this could show that a monthly injection of buprenorphine helps people leaving jail stay in treatment longer and avoid relapse better than daily tablets.
What could go wrong
This is a single open-label study with 240 participants, so results may not apply broadly. Both treatments are already approved, so the main question is which works better in this specific setting.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

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

Started

Jun 2025

Expected to finish

Apr 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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial \[note: individuals who might be sentenced to state/federal prison will be excluded\]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court \[or equivalent\]) will be eligible to participate; * History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration); * Suitability for XR-B and/or SL-B treatment as determined by medical evaluation; * Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community; * Planning to live in Baltimore City or the Baltimore Region; Exclusion Criteria: * Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion); * Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable); * Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant); * Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed); * History of allergic reaction to buprenorphine; * Suicidal ideation (within the past 6 months); * Inability to pass a study enrollment quiz; and * Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Baltimore Central Booking & Intake Center

    RECRUITING

    Baltimore, Maryland, 21202, United States

  • Friends Research Institute

    RECRUITING

    Baltimore, Maryland, 21201, United States

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