The Long-Term Treatment of Drug Addiction and Unemployment

July 19, 2022 updated by: Johns Hopkins University
The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Drug addiction is as a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for drug addiction and can maintain drug abstinence over extended periods of time, but practical methods of implementing these interventions are needed. Workplaces could be ideal and practical vehicles for arranging and maintaining abstinence reinforcement over long time periods. The investigator's research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide drug-free urine samples to maintain maximum pay, can maintain drug abstinence. Now what is needed is the development of effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. The present study will evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement. Under this model, successful Therapeutic Workplace participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. Governments have used wage supplements effectively to increase employment in welfare recipients. The Wage Supplement Model harnesses the power of wage supplements to promote employment, while simultaneously using the wage supplements to reinforce drug abstinence. The intervention will combine the Therapeutic Workplace, Individual Placement and Support (IPS) supported employment, and abstinence-contingent wage supplements. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. Under this model, participants will be exposed to the Therapeutic Workplace to initiate drug abstinence and establish job skills. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. A randomized trial will evaluate the effectiveness and economic benefits of the Abstinence-Contingent Wage Supplement Model in promoting employment and sustaining abstinence in heroin users. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to an IPS Only group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. IPS Only participants will receive the IPS intervention. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. Drug use while participants are employed in community jobs will be monitored by American Substance Abuse Professionals, Inc. (ASAP®), a leading provider of workplace substance abuse services in the U.S. This novel intervention could be an effective and economically sound way to promote long-term abstinence and employment.

Study Type

Interventional

Enrollment (Actual)

91

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
        • 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • report heroin use

Exclusion Criteria:

  • report current suicidal or homicidal ideation;
  • have a severe psychiatric disorder

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IPS Only
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Behavioral: Individual Placement and Support (IPS) supported employment
Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
Experimental: IPS Plus Wage Supplement
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Behavioral: Individual Placement and Support (IPS) supported employment
Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
Behavioral: Abstinence-contingent wage supplements
Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Opiate- and Cocaine-negative Urine Samples
Time Frame: 1 year
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
1 year
The Percentage of Participants Who Are Employed
Time Frame: 1 year
(# participants employed /divided by total # of participants) x 100
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Participants Who Report Injecting Drugs
Time Frame: 1 year
(# participants reporting injecting drugs /divided by total # of participants) x 100
1 year
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money
Time Frame: 1 year
(# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100
1 year
The Percentage of Participants Who Report Sharing Injection Equipment
Time Frame: 1 year
(# participants reporting sharing injection equip/divided by total # of participants) x 100
1 year
The Percentage of Participants With Household Incomes Below the Federal Poverty Level
Time Frame: 1 year
(# participants with incomes below federal poverty level/divided by total # of participants) x 100
1 year
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
Time Frame: Year 2
This will be measured after the intervention ends
Year 2
The Percentage of Participants Who Are Employed Post-intervention
Time Frame: Year 2
This will be measured after the intervention ends
Year 2
The Percentage of Participants Who Report Injecting Drugs Post-intervention
Time Frame: Year 2
This will be measured after the intervention ends
Year 2
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention
Time Frame: Year 2
This will be measured after the intervention ends
Year 2
The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention
Time Frame: Year 2
This will be measured after the intervention ends
Year 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-benefit of Treatment
Time Frame: 2 years
The Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs
2 years

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

November 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00046990
  • R01DA037314-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be 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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