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A Therapeutic Workplace to Address Poverty and Substance Use

Primary Purpose

Substance Use Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPS Plus Abstinence-Contingent Wage Supplement
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Employment

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years or older
  • meet Diagnostic and Statistical Manual (DSM-V) criteria for substance use disorder
  • interested in obtaining employment

Exclusion Criteria:

  • suicidal or homicidal ideation
  • meet Diagnostic and Statistical Manual (DSM-V) criteria for psychotic disorder

Sites / Locations

  • Center for Learning and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IPS Plus Abstinence-Contingent Wage Supplement

Usual Care Control

Arm Description

Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.

Counseling and referrals to employment and treatment programs.

Outcomes

Primary Outcome Measures

Alcohol Abstinence
The number of days of alcohol abstinence during the year-long intervention

Secondary Outcome Measures

Employment
The number of days of employment during the year-long intervention

Full Information

First Posted
April 26, 2018
Last Updated
March 16, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03519009
Brief Title
A Therapeutic Workplace to Address Poverty and Substance Use
Official Title
A Therapeutic Workplace to Address Poverty and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 11, 2022 (Actual)
Study Completion Date
June 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for alcohol and drug addiction and can maintain 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. Investigators' research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide alcohol- or drug-free urine samples to maintain maximum pay, can maintain alcohol and drug abstinence. Now investigators need to develop effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. Investigators are proposing to 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 and alcohol abstinence. The intervention will combine 3 elements -- 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 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 drug abstinence. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to a Usual Care Control group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. Usual Care Control participants will be offered counseling and referrals to employment and treatment programs. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. This novel intervention could be an effective and economically sound way to promote long-term employment and drug abstinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Employment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPS Plus Abstinence-Contingent Wage Supplement
Arm Type
Experimental
Arm Description
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
Arm Title
Usual Care Control
Arm Type
No Intervention
Arm Description
Counseling and referrals to employment and treatment programs.
Intervention Type
Behavioral
Intervention Name(s)
IPS Plus Abstinence-Contingent Wage Supplement
Intervention Description
Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
Primary Outcome Measure Information:
Title
Alcohol Abstinence
Description
The number of days of alcohol abstinence during the year-long intervention
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Employment
Description
The number of days of employment during the year-long intervention
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older meet Diagnostic and Statistical Manual (DSM-V) criteria for substance use disorder interested in obtaining employment Exclusion Criteria: suicidal or homicidal ideation meet Diagnostic and Statistical Manual (DSM-V) criteria for psychotic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Therapeutic Workplace to Address Poverty and Substance Use

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