Status:

COMPLETED

Employment-Based Depot Naltrexone Clinical Trial

Lead Sponsor:

Johns Hopkins University

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Opiate Dependence

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Detailed Description

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulatio...

Eligibility Criteria

Inclusion

  • Individuals were eligible if they:
  • met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,
  • reported using heroin on at least 21 of the last 30 days while in community,
  • were unemployed,
  • were aged 18-65 years,
  • were medically approved for naltrexone
  • lived in or near Baltimore, MD.
  • Individuals were excluded if they
  • had current DSM-IV major Axis I disorders,
  • had current suicidal or homicidal ideation,
  • expressed interest in methadone treatment,
  • were required to use opioids for medical purposes,
  • earned more than $200 in taxable income over the previous 30 days,
  • had physical limitations that would prevent them from using a keyboard,
  • were pregnant or breastfeeding,
  • had serum aminotransferase levels more than three times over normal.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 3 2009

    Estimated Enrollment :

    35 Patients enrolled

    Trial Details

    Trial ID

    NCT00684788

    Start Date

    May 1 2006

    End Date

    May 3 2009

    Last Update

    December 26 2017

    Active Locations (1)

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    The Center for Learning and Health

    Baltimore, Maryland, United States, 21224