Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Alkermes, Inc.; New York City Department of Health and Mental Hygiene
• Treatments: Analgesics, Opioid; Naltrexone

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.