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Completed

Employment-Based Depot Naltrexone Clinical Trial

ClinicalTrials.gov ID NCT00684788
Sponsor Johns Hopkins University
Information provided by Johns Hopkins University (Responsible Party)
Last Update Posted 2017-12-26
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Study Overview

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 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.
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Official Title
Employment-Based Depot Naltrexone Clinical Trial
Conditions
Opiate Dependence
Intervention / Treatment
  • Combination Product: employment-based reinforcement
  • Combination Product: employment-based reinforcement
Other Study ID Numbers
Study Start (Actual)
2006-05
Primary Completion (Actual)
2009-05
Study Completion (Actual)
2009-05-03
Enrollment (Actual)
35
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Maryland Locations
Baltimore, Maryland, United States, 21224

The Center for Learning and Health
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Ages Eligible for Study
18 Years to 65 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm No Intervention: No Intervention
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Intervention/Treatment
Participant Group/Arm Experimental: Employment-based reinforcement
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
Intervention/Treatment Combination Product: employment-based reinforcement
  • Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Percentage of Depot Naltrexone Doses ReceivedThe number of depot naltrexone injections received/divided by the total number of injections possible for each participant.18 Weeks
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
The Time to the First Missed Dose of Depot NaltrexoneThe number of weeks until the first missed dose of depot naltrexone18 weeks
Percentage of 30-day Assessments Urine Samples Negative for Opiates(The number of urine samples that were negative for opiates/total number of urine samples)x 1004 months
Percentage of Monday, Wednesday, Friday Urine Samples Negative for OpiatesTotal number of opiate-negative urine samples divided by the total number of possible urine samples X 10018 weeks
Percentage of 30-day Assessments Urine Samples Negative for Cocaine(The number of urine samples that were negative for cocaine/total number of urine samples)x 1004 months
Percentage of Monday, Wednesday, Friday Urine Samples Negative for CocaineTotal number of cocaine-negative urine samples divided by the total number of possible urine samples X 10018 weeks
HIV Risk BehaviorsWent to a crack house4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Johns Hopkins University
Collaborators
  • National Institute on Drug Abuse (NIDA)
Investigators
  • Principal Investigator:Kenneth Silverman, Ph.D.,Johns Hopkins University

Publications

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2008-05-23
First Submitted that Met QC Criteria
2008-05-23
First Posted (Estimated)
2008-05-28
Results Reporting Dates
Results First Submitted
2016-08-30
Results First Submitted that Met QC Criteria
2017-11-29
Results First Posted
2017-12-26
Study Record Updates
Last Update Submitted that met QC Criteria
2017-11-29
Last Update Posted
2017-12-26
Last Verified
2017-11

More Information

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Keywords Provided by Johns Hopkins University
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No