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Completed

NCT Number: NCT00684788

Employment-Based Depot Naltrexone Clinical Trial

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Center for Learning and Health

Baltimore, Maryland, 21224, United States

About this study

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 formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

employment-based reinforcement

Combination Product

Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Primary outcomes

  1. Percentage of Depot Naltrexone Doses Received

    Time frame: 18 Weeks

    The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.

Secondary outcomes

  1. The Time to the First Missed Dose of Depot Naltrexone

    Time frame: 18 weeks

    The number of weeks until the first missed dose of depot naltrexone

  2. Percentage of 30-day Assessments Urine Samples Negative for Opiates

    Time frame: 4 months

    (The number of urine samples that were negative for opiates/total number of urine samples)x 100

  3. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates

    Time frame: 18 weeks

    Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100

  4. Percentage of 30-day Assessments Urine Samples Negative for Cocaine

    Time frame: 4 months

    (The number of urine samples that were negative for cocaine/total number of urine samples)x 100

  5. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine

    Time frame: 18 weeks

    Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100

  6. HIV Risk Behaviors

    Time frame: 4 months

    Went to a crack house

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 28, 2008
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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