- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519009
A Therapeutic Workplace to Address Poverty and Substance Use
March 20, 2024 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
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 Contact
- Name: Recruitment Center
- Phone Number: 1-866-857-9851
- Email: jhampton@jhmi.edu
Study Contact Backup
- Name: Kenneth Silverman, Ph.D.
- Phone Number: 410-550-2694
- Email: ksilverm@jhmi.edu
Study Locations
-
-
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 to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: IPS Plus Abstinence-Contingent Wage Supplement
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
|
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.
|
No Intervention: Usual Care Control
Counseling and referrals to employment and treatment programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Abstinence
Time Frame: 1 year
|
The number of days of alcohol abstinence during the year-long intervention
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employment
Time Frame: 1 year
|
The number of days of employment during the year-long intervention
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth Silverman, Ph.D., Johns Hopkins University
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)
January 2, 2019
Primary Completion (Actual)
December 11, 2022
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
April 26, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (Actual)
May 8, 2018
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00160297
- R01AA024101 (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
No
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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