Clinical trial NCT02487745: The Long-Term Treatment of Drug Addiction and Unemployment
Official title: The Long-Term Treatment of Drug Addiction and Unemployment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse, Intravenous
Keywords: Cocaine
Methadone
Employment
Opioids
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-07-01
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* report heroin use

Exclusion Criteria:

* report current suicidal or homicidal ideation;
* have a severe psychiatric disorder

Primary outcomes:
measure: The Percentage of Opiate- and Cocaine-negative Urine Samples
timeFrame: 1 year
measure: The Percentage of Participants Who Are Employed
timeFrame: 1 year
Secondary outcomes:
measure: The Percentage of Participants Who Report Injecting Drugs
timeFrame: 1 year
measure: The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money
timeFrame: 1 year
measure: The Percentage of Participants Who Report Sharing Injection Equipment
timeFrame: 1 year
measure: The Percentage of Participants With Household Incomes Below the Federal Poverty Level
timeFrame: 1 year
measure: The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
timeFrame: Year 2
measure: The Percentage of Participants Who Are Employed Post-intervention
timeFrame: Year 2
measure: The Percentage of Participants Who Report Injecting Drugs Post-intervention
timeFrame: Year 2
measure: The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention
timeFrame: Year 2
measure: The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention
timeFrame: Year 2
Other outcomes:
measure: Cost-benefit of Treatment
timeFrame: 2 years
Locations:
city: Baltimore
country: United States
facility: Center for Learning and Health
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kenneth Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holtyn AF, Toegel F, Subramaniam S, Jarvis BP, Leoutsakos JM, Fingerhood M, Silverman K. Abstinence-contingent wage supplements to promote drug abstinence and employment: a randomised controlled trial. J Epidemiol Community Health. 2020 May;74(5):445-452. doi: 10.1136/jech-2020-213761. Epub 2020 Feb 21.