Clinical trial NCT01180647: Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Official title: Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opiate Dependence
Keywords: Extended-release naltrexone
Prisoners
Opioid addiction prevention
Medication Treatment Alternatives
Prevention of Relapse to Opioid Addiction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
name: New York City Department of Health and Mental Hygiene
First posted: 2010-08-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

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 other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.

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.

Primary outcomes:
measure: Post-Release Opioid Relapse
timeFrame: Four weeks post-release
Secondary outcomes:
measure: Participation in Community Drug Treatment Post-release
timeFrame: Four weeks post-release
measure: Any Opioid Use Post-release
timeFrame: Four weeks post-release
measure: Injection Drug Use Post-release
timeFrame: Four weeks post-release
measure: Accidental Drug Overdose
timeFrame: Four weeks post-release
measure: Adverse Events and Serious Adverse Events
timeFrame: Eight weeks post-release
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: New York City Department of Correction
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Joshua D Lee, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.