drugset / Trial / NCT01999946
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Phase 4
Completed
217 enrolled
NYU Langone Health
Friends Research Institute, Inc. · collabNational Institute on Drug Abuse (NIDA) · collabUniversity of California, Los Angeles · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-06-27
- Primary completion
- 2019-05-28
- Completion
- 2020-12-24
Publications
- Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
- Velasquez M, Flannery M, Badolato R, Vittitow A, McDonald RD, Tofighi B, Garment AR, Giftos J, Lee JD. Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments following release from jail. Addict Sci Clin Pract. 2019 Oct 1;14(1):37. doi: 10.1186/s13722-019-0166-0.
- McDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M, Santana-Correa N, Johnson CW, Leibowitz N, Rotrosen J, Gourevitch MN, Lee JD. Extended-release naltrexone opioid treatment at jail reentry (XOR). Contemp Clin Trials. 2016 Jul;49:57-64. doi: 10.1016/j.cct.2016.05.002. Epub 2016 May 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 380 mg | Intramuscular |