Jail-to-Freedom: which shot keeps opioid addiction in check?
NCT ID NCT04408313
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
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Oct 2020
- Expected to finish
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May 2026
An estimate. End dates often move.
- 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
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18 years and older
- Sex
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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: * 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
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Other studies related to the condition(s) this trial covers.
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