A Therapeutic Workplace to Address Poverty and Substance Use

NCT03519009 | Completed Results DMC

• 2 other identifiers: IRB00160297R01AA024101
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Keywords

Employment

Outcome Measures

Primary Outcomes (1)

• Alcohol Abstinence

  Percentage of participants abstinent per month

  1 year

Secondary Outcomes (1)

• Employment

  1 year

Study Arms (2)

IPS Plus Abstinence-Contingent Wage Supplement

EXPERIMENTAL

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

Behavioral: IPS Plus Abstinence-Contingent Wage Supplement

Usual Care Control

NO INTERVENTION

Counseling and referrals to employment and treatment programs.

Interventions

IPS Plus Abstinence-Contingent Wage Supplement BEHAVIORAL

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.

IPS Plus Abstinence-Contingent Wage Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Novak MD, Toegel F, Holtyn AF, Rodewald AM, Arellano M, Baranski M, Barnett NP, Leoutsakos JM, Fingerhood M, Silverman K. Abstinence-contingent wage supplements for adults experiencing homelessness and alcohol use disorder: A randomized clinical trial. Prev Med. 2023 Nov;176:107655. doi: 10.1016/j.ypmed.2023.107655. Epub 2023 Aug 3.

  PMID: 37541600 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Myo-Inositol-1-Phosphate Synthase

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Intramolecular Lyases; Isomerases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Professor
• Organization: Johns Hopkins University

ksilverm@jhmi.edu

4436176051

Study Officials

• Kenneth Silverman, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: January 2, 2019
• Primary Completion: December 11, 2022
• Study Completion: March 1, 2024
• Last Updated: June 27, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)