Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2

October 26, 2017 updated by: Johns Hopkins University

A Therapeutic Workplace for Drug Abusers

The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current study is a continuation of the research into the development and evaluation of a novel treatment designed to address the chronic, persistent nature of drug addiction. This treatment, called the Therapeutic Workplace, integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for about 5 years. This study reports the effects of the intervention over a follow-up period of 8 years after treatment initiation.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • When originally enrolled in the study, participants were at least 18 years old, unemployed, and methadone maintenance patients of the Center for Addiction and Pregnancy (CAP) who continued to use opiates or cocaine during CAP treatment.

Exclusion Criteria:

  • Participants were excluded if they were at risk for suicide at the time of intake or if they had serious psychiatric illness (e.g., schizophrenia).

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
Experimental: Therapeutic Workplace
Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments.
Behavioral: Contingency management
Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.
No Intervention: Usual Care Control Group
No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of urine samples at the assessments that were negative for cocaine
Time Frame: every 30 days throughout fourth year
(total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100
every 30 days throughout fourth year
Percentage of urine samples at the assessments that were negative for opiates
Time Frame: every 30 days throughout fourth year
(total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100
every 30 days throughout fourth year
Percentage of urine samples at the assessments that were negative for cocaine and opiates
Time Frame: every 30 days throughout fourth year
(total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100
every 30 days throughout fourth year

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV risk behaviors
Time Frame: every 30 days throughout fourth year
every 30 days throughout fourth year
Percentage of participants employed each month
Time Frame: every 30 days throughout fourth year
every 30 days throughout fourth year
Number of days employed each month
Time Frame: every 30 days throughout fourth year
every 30 days throughout fourth year
Percentage of participants to self-report abstinence at all time points
Time Frame: every 30 days throughout fourth year
every 30 days throughout fourth year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

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

October 1, 1996

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-13107-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data for this study have been published in a peer-reviewed journal.

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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