Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

Completed · Phase 4

Conditions studied: Heroin Dependence, Opioid-Related Disorders

In brief

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.

Key facts

Study ID

NCT01999946

Run by

NYU Langone Health

People needed

217

Starts

2014-06-27

Expected to finish

2020-12-24

Last updated by the study team

2021-06-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults >18yo incarcerated in NYC jails with known release dates.
• DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
• Not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release.
• Currently opioid free by history ('detoxed') and with a negative urine for all opioids.
• General good health as determined by medical evaluation.

You may not qualify if…

• Pregnancy, lactation, or planning conception.
• Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
• Untreated or poorly controlled psychiatric disorder precluding safe participation.
• History of allergic reaction to naltrexone.
• Current chronic pain condition treated with opioids.
• Non-Randomized Arm (MTP) Inclusion Criteria
• Adults >18yo incarcerated in NYC jails with known release dates.
• DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
• Currently receiving regular methadone maintenance treatment through KEEP.
• General good health as determined by medical evaluation.
• Exclusion Criteria
• Pregnancy, lactation, or planning conception.
• Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
• Untreated or poorly controlled psychiatric disorder precluding safe participation.
• In community methadone treatment program at the time of most recent arrest.

Where it is running

• Bellevue Hospital Center — New York, New York, United States
• NYC Department of Corrections: Rikers Island Jail Facilities — New York, New York, United States

Full record on ClinicalTrials.gov

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