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

NCT01180647 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-04-07

Study results available
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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.

Conditions

  • Opiate Dependence

Interventions

DRUG

Extended-Release Naltrexone

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).

BEHAVIORAL

Motivational Enhancement Counseling

The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Sponsors & Collaborators

  • Alkermes, Inc.

    collaborator INDUSTRY

  • New York City Department of Health and Mental Hygiene

    collaborator OTHER_GOV

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Joshua D Lee, MD MSc · NYU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01180647 on ClinicalTrials.gov