Phase 3
Completed N=34
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Opiate Dependence
Source: ClinicalTrials.gov NCT01180647 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Post-Release Opioid Relapse — 6; 15 participants
◆ Published Evidence
Highly cited
110citations · ~10 / year
Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial.
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.
Linked Publications (2)
-
Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial.
-
Sustained-release naltrexone for opioid dependence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Release Opioid Relapse |
6; 15 | — |
| SECONDARY Participation in Community Drug Treatment Post-release |
19; 12 | — |
| SECONDARY Any Opioid Use Post-release |
17; 82 | — |
| SECONDARY Injection Drug Use Post-release |
25; 6 | — |
| SECONDARY Accidental Drug Overdose |
0; 0 | — |
| SECONDARY Adverse Events and Serious Adverse Events |
5; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Adults incarcerated in NYC jails with known release date
- DSM-IV criteria for current opioid dependence
- No current agonist (methadone, buprenorphine) treatment
- Currently opioid free by history ('detoxed') and with a negative urine for all opioids
- General good health as determined by complete medical interview and physical examination
- Age 18-60 years.
Exclusion Criteria
- History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
- Pregnancy, lactation, or planning conception
- Active medical illness that might make participation hazardous
- Untreated psychiatric disorder
- History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
- Current chronic pain condition treated with opioids.
Data sourced from ClinicalTrials.gov (NCT01180647) and the linked publication. 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. Informational only — not medical advice.