Please select the eligibility criteria that correspond to the clinical trial below.
Title: Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Brief 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.


Options:
A: Inclusion Criteria:

1. HIV+
2. Inmates returning to New Haven or Hartford
3. Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
4. Gives informed consent
5. English or Spanish speaker
6. \> 18 yrs

Exclusion Criteria:

1. On opiate pain medication or expressing need for them
2. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \> 5x the upper limit of normal
3. Evidence of Child's Pugh Class C cirrhosis
4. Pending felony charges
5. Pregnant or unwilling to take contraceptive measures
6. Subject is part of another pharmacological research study
B: 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.
C: Specific site inclusion criteria include: (a) ability to provide youth service records, (b) service to youth under community supervision, (c) access to treatment provider(s) if treatment is not provided directly by the JJ agency, (d) participation in requisite intervention training/activities,(e) minimum average case flow of 10 youth per month, (f) minimum of 10 staff per site, and (g) a senior JJ staff member who agrees to serve as site leader/liaison during the study. Study sites are geographically dispersed and were identified by state JJ agencies (and not selected for particular substance use or related BH service needs).

Youth inclusion criteria include: all youth entering the juvenile justice system during the period within the exception of those who are already in treatment at the time that they are referred to the juvenile justice agency.

Staff inclusion criteria include: all staff actively working with the youth under community supervision in the site with exclusion only of higher level administrative or regional staff over multiple units..
D: Inclusion Criteria:

1. Meets DSM-IV criteria for opioid dependence
2. Age \> 18 years
3. Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
4. Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.
5. No participation in pharmacotherapy trial in the previous 30 days
6. Not pregnant

Exclusion Criteria:

1. Unable to provide informed consent
2. Verbally or physically threatening to research staff
3. Unable to communicate in either English or Spanish
4. Pending trials for a felony
5. Liver failure (Childs-Pugh Class B or C Cirrhosis)
6. Grade IV Hepatitis (liver function tests \> 10X normal)
7. Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
8. Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
9. Active opioid withdrawal (within 3-5 days since last opioid ingestion)
10. Pregnancy or unwilling to take contraceptives measures
11. Breast-feeding

Answer: B