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

Completed · Phase 3

Conditions studied: Opiate Dependence

In brief

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.

Key facts

Study ID

NCT01180647

Run by

NYU Langone Health

People needed

48

Starts

2010-05-01

Expected to finish

2013-07-01

Last updated by the study team

2016-04-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New York University School of Medicine — New York, New York, United States
• New York City Department of Correction — New York, New York, United States

Full record on ClinicalTrials.gov

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