Employment-Based Depot Naltrexone Clinical Trial

November 29, 2017 updated by: Johns Hopkins University
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • The Center for Learning and Health

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Intervention
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Experimental: Employment-based reinforcement
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 weeks
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
4 months
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
18 weeks
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
4 months
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
18 weeks
HIV Risk Behaviors
Time Frame: 4 months
Went to a crack house
4 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 Major Dates

Study Start (Actual)

May 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 3, 2009

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00000928-1
  • R01DA019497 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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