Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Condition: Heroin Dependence; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Intervention: Extended-Release Naltrexone
Intervention description: Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Heroin Dependence; Opioid-Related Disorders

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.
    

Eligibility 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.