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Trial record 2 of 35 for:    Not yet recruiting Studies | Substance Use

A Therapeutic Workplace to Address Poverty and Substance Use

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ClinicalTrials.gov Identifier: NCT03519009
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: IPS Plus Abstinence-Contingent Wage Supplement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Therapeutic Workplace to Address Poverty and Substance Use
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPS Plus Abstinence-Contingent Wage Supplement
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
Behavioral: IPS Plus Abstinence-Contingent Wage Supplement
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.



Primary Outcome Measures :
  1. Alcohol Abstinence [ Time Frame: 1 year ]
    The number of days of alcohol abstinence during the year-long intervention


Secondary Outcome Measures :
  1. Employment [ Time Frame: 1 year ]
    The number of days of employment during the year-long intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519009


Contacts
Contact: Recruitment Center 1-866-857-9851 jhampton@jhmi.edu
Contact: August F. Holtyn, Ph.D. 410-550-5370 aholtyn1@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03519009     History of Changes
Other Study ID Numbers: IRB00160297
R01AA024101 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Employment

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders