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A Therapeutic Workplace to Address Poverty and Substance Use

A Therapeutic Workplace to Address Poverty and Substance Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03519009
Enrollment
152
Registered
2018-05-08
Start date
2019-01-02
Completion date
2024-03-01
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Keywords

Employment

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.

Interventions

BEHAVIORALIPS 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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Abstinence1 yearPercentage of participants abstinent per month

Secondary

MeasureTime frameDescription
Employment1 yearPercentage of participants employed per month

Countries

United States

Participant flow

Recruitment details

Participants were recruited from treatment clinics and recovery houses serving adults with alcohol use disorder, online job boards, and through compensated referrals by participants. Participants were recruited from 2 January 2019 through 5 March 2020 and from 29 October 2020 through 12 May 2022. The pause in recruitment was due to regional and institutional restrictions related to the COVID-19 pandemic. Most of the study was conducted remotely because of the COVID-19 pandemic.

Pre-assignment details

This was a two-group randomized clinical trial. All participants completed a 1-month Phase 1 Induction and Initiation period and were then randomly assigned to an intervention or control group. After random assignment, participants completed a 6-month Phase 2 Intervention period and completed study assessments every month.

Participants by arm

ArmCount
IPS Plus Abstinence-Contingent Wage Supplement
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment. 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.
62
Usual Care Control
Counseling and referrals to employment and treatment programs.
57
Total119

Baseline characteristics

CharacteristicIPS Plus Abstinence-Contingent Wage SupplementTotalUsual Care Control
Age, Continuous39.2 years
STANDARD_DEVIATION 7.7
39.4 years
STANDARD_DEVIATION 8.1
39.6 years
STANDARD_DEVIATION 8.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
19 Participants43 Participants24 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
42 Participants73 Participants31 Participants
Region of Enrollment
United States
62 Participants119 Participants57 Participants
Sex: Female, Male
Female
10 Participants18 Participants8 Participants
Sex: Female, Male
Male
52 Participants101 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 620 / 57
other
Total, other adverse events
0 / 620 / 57
serious
Total, serious adverse events
3 / 623 / 57

Outcome results

Primary

Alcohol Abstinence

Percentage of participants abstinent per month

Time frame: 1 year

Population: Intent to treat

ArmMeasureValue (NUMBER)
IPS Plus Abstinence-Contingent Wage SupplementAlcohol Abstinence82.8 percentage of participants
Usual Care ControlAlcohol Abstinence60.2 percentage of participants
p-value: <0.00195% CI: [1.8, 6.3]longitudinal logistic regression
Secondary

Employment

Percentage of participants employed per month

Time frame: 1 year

Population: intent-to-treat

ArmMeasureValue (NUMBER)
IPS Plus Abstinence-Contingent Wage SupplementEmployment51.3 percentage of participants
Usual Care ControlEmployment31.6 percentage of participants
p-value: <0.00195% CI: [1.5, 4.4]longitudinal logistic regression

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026