Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry (XOR)
Heroin Dependence, Opioid-Related Disorders
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring Heroin Dependence, Opioid-Related Disorders
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:
- 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.
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.
- 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.
Sites / Locations
- Bellevue Hospital Center
- NYC Department of Corrections: Rikers Island Jail Facilities
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
Extended-Release Naltrexone (XR-NTX)
Enhanced Treatment As Usual (ETAU)
Methadone Treatment Program (MTP)
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Enhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.