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Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

NCT01999946 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2021-06-25

Study results available
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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.

Conditions

  • Heroin Dependence
  • Opioid-Related Disorders

Interventions

DRUG

Extended-Release Naltrexone

Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • Joshua D Lee, MD MS · NYU MEDICAL CENTER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2019-05-28
Completion
2020-12-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999946 on ClinicalTrials.gov