Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
1 other identifier
interventional
48
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2010
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
April 7, 2016
CompletedApril 7, 2016
March 1, 2016
3.2 years
August 10, 2010
April 13, 2015
March 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-Release Opioid Relapse
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
Four weeks post-release
Secondary Outcomes (5)
Participation in Community Drug Treatment Post-release
Four weeks post-release
Any Opioid Use Post-release
Four weeks post-release
Injection Drug Use Post-release
Four weeks post-release
Accidental Drug Overdose
Four weeks post-release
Adverse Events and Serious Adverse Events
Eight weeks post-release
Study Arms (2)
Extended-release naltrexone (XR-NTX)
ACTIVE COMPARATORA single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Motivational Enhancement Counseling Only
PLACEBO COMPARATORThe randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Interventions
380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Alkermes, Inc.collaborator
- New York City Department of Health and Mental Hygienecollaborator
Study Sites (2)
New York University School of Medicine
New York, New York, 10016, United States
New York City Department of Correction
New York, New York, 11370, United States
Related Publications (2)
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
PMID: 40342086DERIVEDLee 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.
PMID: 25703440DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of this pilot study are: small sample size, no females enrolled in study, and no placebo control group.
Results Point of Contact
- Title
- Joshua D. Lee
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua D Lee, MD MSc
NYU School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 12, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
April 7, 2016
Results First Posted
April 7, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share