Status:
COMPLETED
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Alkermes, Inc.
New York City Department of Health and Mental Hygiene
Conditions:
Opiate Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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, amo...
Detailed Description
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01180647
Start Date
May 1 2010
End Date
July 1 2013
Last Update
April 7 2016
Active Locations (2)
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1
New York University School of Medicine
New York, New York, United States, 10016
2
New York City Department of Correction
New York, New York, United States, 11370