drugset / Trial / NCT01180647
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Phase 3
Completed
48 enrolled
NYU Langone Health
Alkermes, Inc. · collabNew York City Department of Health and Mental Hygiene · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
Timeline
- Start
- 2010-05
- Primary completion
- 2013-07
- Completion
- 2013-07
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.
- Lee JD, McDonald R, Grossman E, McNeely J, Laska E, Rotrosen J, Gourevitch MN. Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial. Addiction. 2015 Jun;110(6):1008-14. doi: 10.1111/add.12894. Epub 2015 Apr 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naltrexone | Small molecule | 380 mg | Intramuscular |