Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
XOR
2 other identifiers
interventional
217
1 country
2
Brief Summary
The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2014
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedStudy Start
First participant enrolled
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedResults Posted
Study results publicly available
May 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2020
CompletedJune 25, 2021
June 1, 2021
4.9 years
November 26, 2013
April 30, 2020
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail
Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized ETAU following release from jail measured up to 24 weeks by Urine Toxicology results and self-report on the TLFB.
up to 24 weeks
Secondary Outcomes (6)
Time-to-relapse: XR-NTX vs. Methadone (MTP) Cohort Following Release From Jail
up to 24 weeks
Community Treatment Retention/Initiation Post-release
up to 24 weeks
Any Drug or Alcohol Misuse
up to 24 weeks
Injection Drug Use and HIV Sexual Risk Factors
up to 24 weeks
Accidental Drug Overdose and Mortality
up to 28 weeks
- +1 more secondary outcomes
Study Arms (3)
Extended-Release Naltrexone (XR-NTX)
EXPERIMENTALExtended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Enhanced Treatment As Usual (ETAU)
NO INTERVENTIONEnhanced Treatment As Usual arm will not receive any study medication, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.
Methadone Treatment Program (MTP)
NO INTERVENTIONQuasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
Interventions
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Eligibility Criteria
You may not qualify if:
- Randomized Arms (XR-NTX, ETAU)
- Adults \>18yo incarcerated in NYC jails with known release dates.
- DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
- Not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release.
- Currently opioid free by history ('detoxed') and with a negative urine for all opioids.
- General good health as determined by medical evaluation.
- Pregnancy, lactation, or planning conception.
- Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
- Untreated or poorly controlled psychiatric disorder precluding safe participation.
- History of allergic reaction to naltrexone.
- Current chronic pain condition treated with opioids.
- Adults \>18yo incarcerated in NYC jails with known release dates.
- DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
- Currently receiving regular methadone maintenance treatment through KEEP.
- General good health as determined by medical evaluation.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Drug Abuse (NIDA)collaborator
- Friends Research Institute, Inc.collaborator
- University of California, Los Angelescollaborator
Study Sites (2)
Bellevue Hospital Center
New York, New York, 10016, United States
NYC Department of Corrections: Rikers Island Jail Facilities
New York, New York, 11370, United States
Related Publications (3)
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: 40342086DERIVEDVelasquez M, Flannery M, Badolato R, Vittitow A, McDonald RD, Tofighi B, Garment AR, Giftos J, Lee JD. Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments following release from jail. Addict Sci Clin Pract. 2019 Oct 1;14(1):37. doi: 10.1186/s13722-019-0166-0.
PMID: 31570100DERIVEDMcDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M, Santana-Correa N, Johnson CW, Leibowitz N, Rotrosen J, Gourevitch MN, Lee JD. Extended-release naltrexone opioid treatment at jail reentry (XOR). Contemp Clin Trials. 2016 Jul;49:57-64. doi: 10.1016/j.cct.2016.05.002. Epub 2016 May 10.
PMID: 27178765DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joshua Lee, MD MS
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua D Lee, MD MS
NYU MEDICAL CENTER
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 3, 2013
Study Start
June 27, 2014
Primary Completion
May 28, 2019
Study Completion
December 24, 2020
Last Updated
June 25, 2021
Results First Posted
May 27, 2020
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share