Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Friends Research Institute, Inc.
• Treatments: Buprenorphine; Naltrexone

Criteria

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.