Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

• Status: Completed
• Trial end date: 2020-12-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Friends Research Institute, Inc.; National Institute on Drug Abuse (NIDA); University of California, Los Angeles
• Treatments: Analgesics, Opioid; Naltrexone

Criteria

Due to the nature of this study, which includes both randomized arms (XR-NTX and enhanced TAU) as well as a non-randomized observational arm (methadone treatment group, MTP) there are separate Inclusion/Exclusion criteria for those randomized vs. Non-Randomized, detailed below.

Randomized Arms (XR-NTX, ETAU)

Inclusion Criteria:

1. Adults >18yo incarcerated in NYC jails with known release dates.

2. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).

3. Not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release.

4. Currently opioid free by history ('detoxed') and with a negative urine for all opioids.

5. General good health as determined by medical evaluation.

Exclusion Criteria:

1. Pregnancy, lactation, or planning conception.

2. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.

3. Untreated or poorly controlled psychiatric disorder precluding safe participation.

4. History of allergic reaction to naltrexone.

5. Current chronic pain condition treated with opioids.

Non-Randomized Arm (MTP) Inclusion Criteria

1. Adults >18yo incarcerated in NYC jails with known release dates.

2. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).

3. Currently receiving regular methadone maintenance treatment through KEEP.

4. General good health as determined by medical evaluation.

Exclusion Criteria

1. Pregnancy, lactation, or planning conception.

2. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.

3. Untreated or poorly controlled psychiatric disorder precluding safe participation.

4. In community methadone treatment program at the time of most recent arrest.