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Jail-to-Freedom: which shot keeps opioid addiction in check?

NCT ID NCT04408313

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares two long-acting injectable medications—extended-release naltrexone and extended-release buprenorphine—for people with opioid use disorder who are leaving jail. 240 participants from Maryland jails will receive monthly shots for six months after release. The goal is to see which medication helps them stay in treatment and avoid opioid use or overdose.

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 naltrexone and extended-release buprenorphine
What this could lead to
If this trial succeeds, it could show which long-acting medication works better to help people leaving jail stay in treatment and avoid relapse or overdose.
What could go wrong
This is a mid-stage trial with 240 participants, so results may not apply to everyone. Both medications have side effects and may not work for all individuals.

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

About 240 people

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

Started

Oct 2020

Expected to finish

May 2026

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

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: * Adult male or female inmates at participating jails who are eligible for release within 120 days * 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 XR-NTX treatment as determined by medical evaluation * Willingness to enroll in XR-B or XR-NTX treatment in jail * Planning to live in one of the 7 participating counties and/or surrounding counties Exclusion Criteria: * Liver function test levels greater than 4 times normal; * 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 naltrexone and/or buprenorphine; * Current chronic pain diagnosis for which opioids are prescribed; * Pregnancy (for women); * Breast-feeding (for women); * Suicidal ideation (within the past 6 months); * Body Mass Index (BMI) \> 40; * Inability to pass a study enrollment quiz; * Currently enrolled in jail-based MOUD pharmacotherapy (methadone, buprenorphine, naltrexone) * Enrolled in a methadone treatment program in the past 30 days.

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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

  • Friends Research Institute

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.