Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
Running, not enrolling · Phase 2/Phase 3
Conditions studied: Opioid-use Disorder
In brief
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.
Key facts
- Study ID
- NCT04408313
- Run by
- Friends Research Institute, Inc.
- People needed
- 240
- Starts
- 2020-10-28
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Friends Research Institute — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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