The Long-Term Treatment of Drug Addiction and Unemployment

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement.

Detailed Description
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Drug addiction is as a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for drug addiction and can maintain drug 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. The investigator's research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide drug-free urine samples to maintain maximum pay, can maintain drug abstinence. Now what is needed is the development of effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. The present study will 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 abstinence. The intervention will combine 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 drug 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 abstinence in heroin users. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to an IPS Only group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. IPS Only participants will receive the IPS intervention. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. Drug use while participants are employed in community jobs will be monitored by American Substance Abuse Professionals, Inc. (ASAP®), a leading provider of workplace substance abuse services in the U.S. This novel intervention could be an effective and economically sound way to promote long-term abstinence and employment.

Official Title
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The Long-Term Treatment of Drug Addiction and Unemployment

Conditions
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Substance Abuse, Intravenous

Intervention / Treatment
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* Behavioral: Abstinence-contingent wage supplements
* Behavioral: Individual Placement and Support (IPS) supported employment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: report heroin use Exclusion Criteria: report current suicidal or homicidal ideation; have a severe psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPS Only<br>IPS Only participants will receive the Individual Placement and Support (IPS) supported employment. | Behavioral: Individual Placement and Support (IPS) supported employment<br>* Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.<br>|
| Experimental: IPS Plus Wage Supplement<br>IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements. | Behavioral: Abstinence-contingent wage supplements<br>* Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.<br>Behavioral: Individual Placement and Support (IPS) supported employment<br>* Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Opiate- and Cocaine-negative Urine Samples | (# opiate- and cocaine-negative urine samples/divided by possible #) x 100 | 1 year | 
| The Percentage of Participants Who Are Employed | (# participants employed /divided by total # of participants) x 100 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Who Report Injecting Drugs | (# participants reporting injecting drugs /divided by total # of participants) x 100 | 1 year | 
| The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money | (# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100 | 1 year | 
| The Percentage of Participants Who Report Sharing Injection Equipment | (# participants reporting sharing injection equip/divided by total # of participants) x 100 | 1 year | 
| The Percentage of Participants With Household Incomes Below the Federal Poverty Level | (# participants with incomes below federal poverty level/divided by total # of participants) x 100 | 1 year | 
| The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention | This will be measured after the intervention ends | Year 2 | 
| The Percentage of Participants Who Are Employed Post-intervention | This will be measured after the intervention ends | Year 2 | 
| The Percentage of Participants Who Report Injecting Drugs Post-intervention | This will be measured after the intervention ends | Year 2 | 
| The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention | This will be measured after the intervention ends | Year 2 | 
| The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention | This will be measured after the intervention ends | Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, Methadone, Employment, Opioids