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The Long-Term Treatment of Drug Addiction and Unemployment

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ClinicalTrials.gov Identifier: NCT02487745
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Substance Abuse, Intravenous Behavioral: Abstinence-contingent wage supplements Behavioral: Individual Placement and Support (IPS) supported employment

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Long-Term Treatment of Drug Addiction and Unemployment
Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: IPS Only
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Behavioral: Individual Placement and Support (IPS) supported employment
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.
Experimental: IPS Plus Wage Supplement
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
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.
Behavioral: Individual Placement and Support (IPS) supported employment
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.


Outcome Measures

Primary Outcome Measures :
  1. The percentage of opiate- and cocaine-negative urine samples [ Time Frame: 1 year ]
    (# opiate- and cocaine-negative urine samples/divided by possible #) x 100

  2. The percentage of participants who are employed [ Time Frame: 1 year ]
    (# participants employed /divided by total # of participants) x 100


Secondary Outcome Measures :
  1. The percentage of participants who report injecting drugs [ Time Frame: 1 year ]
    (# participants reporting injecting drugs /divided by total # of participants) x 100

  2. The percentage of participants who report trading unprotected sex for drugs or money [ Time Frame: 1 year ]
    (# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100

  3. The percentage of participants who report sharing injection equipment [ Time Frame: 1 year ]
    (# participants reporting sharing injection equip/divided by total # of participants) x 100

  4. The percentage of participants with household incomes below the federal poverty level [ Time Frame: 1 year ]
    (# participants with incomes below federal poverty level/divided by total # of participants) x 100

  5. The percentage of opiate- and cocaine-negative urine samples post-intervention [ Time Frame: Year 2 ]
    This will be measured after the intervention ends

  6. The percentage of participants who are employed post-intervention [ Time Frame: Year 2 ]
    This will be measured after the intervention ends

  7. The percentage of participants who report injecting drugs post-intervention [ Time Frame: Year 2 ]
    This will be measured after the intervention ends

  8. The percentage of participants who report trading unprotected sex for drugs or money post-intervention [ Time Frame: Year 2 ]
    This will be measured after the intervention ends

  9. The percentage of participants who report sharing injection equipment post-intervention [ Time Frame: Year 2 ]
    This will be measured after the intervention ends


Other Outcome Measures:
  1. Cost-benefit of treatment [ Time Frame: 2 years ]
    The Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • report heroin use

Exclusion Criteria:

  • report current suicidal or homicidal ideation;
  • have a severe psychiatric disorder
Contacts and Locations

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): NCT02487745


Contacts
Contact: Kenneth Silverman, PhD 410-550-2694 ksilverm@jhmi.edu
Contact: August F Holtyn, PhD 410-550-5370 aholtyn1@jhmi.edu

Locations
United States, Maryland
Center for Learning and Health Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kenneth Silverman, PhD    410-550-2694    ksilverm@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kenneth Silverman, PhD Johns Hopkins University
More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02487745     History of Changes
Other Study ID Numbers: NIDA-37314-1
R01DA037314-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be published in a peer-reviewed journal.

Keywords provided by Johns Hopkins University:
Cocaine
Methadone
Employment
Opioids

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