Phase 4
N=198
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Heroin Dependence · Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01999946 ↗Enrolled (actual)
198
Serious AEs
13.9%
Results posted
May 2020
Primary outcome: Primary: Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail — 8.6; 5.9 Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Extended-Release Naltrexone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail |
8.6; 5.9 | — |
| SECONDARY Time-to-relapse: XR-NTX vs. Methadone (MTP) Cohort Following Release From Jail |
— | — |
| SECONDARY Community Treatment Retention/Initiation Post-release |
— | — |
| SECONDARY Any Drug or Alcohol Misuse |
— | — |
| SECONDARY Injection Drug Use and HIV Sexual Risk Factors |
— | — |
| SECONDARY Accidental Drug Overdose and Mortality |
— | — |
| SECONDARY Re-incarceration and Exploratory Cost-effectiveness |
— | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01999946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.