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The Long-Term Treatment of Drug Addiction and Unemployment

Primary Purpose

Substance Abuse, Intravenous

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstinence-contingent wage supplements
Individual Placement and Support (IPS) supported employment
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse, Intravenous focused on measuring Cocaine, Methadone, Employment, Opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • report heroin use

Exclusion Criteria:

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

Sites / Locations

  • Center for Learning and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IPS Only

IPS Plus Wage Supplement

Arm Description

IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.

IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.

Outcomes

Primary Outcome Measures

The Percentage of Opiate- and Cocaine-negative Urine Samples
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
The Percentage of Participants Who Are Employed
(# participants employed /divided by total # of participants) x 100

Secondary Outcome Measures

The Percentage of Participants Who Report Injecting Drugs
(# participants reporting injecting drugs /divided by total # of participants) x 100
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
The Percentage of Participants Who Report Sharing Injection Equipment
(# participants reporting sharing injection equip/divided by total # of participants) x 100
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
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
This will be measured after the intervention ends
The Percentage of Participants Who Are Employed Post-intervention
This will be measured after the intervention ends
The Percentage of Participants Who Report Injecting Drugs Post-intervention
This will be measured after the intervention ends
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention
This will be measured after the intervention ends
The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention
This will be measured after the intervention ends

Full Information

First Posted
June 19, 2015
Last Updated
July 19, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02487745
Brief Title
The Long-Term Treatment of Drug Addiction and Unemployment
Official Title
The Long-Term Treatment of Drug Addiction and Unemployment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Intravenous
Keywords
Cocaine, Methadone, Employment, Opioids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPS Only
Arm Type
Active Comparator
Arm Description
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Arm Title
IPS Plus Wage Supplement
Arm Type
Experimental
Arm Description
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Intervention Type
Behavioral
Intervention Name(s)
Abstinence-contingent wage supplements
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support (IPS) supported employment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Percentage of Opiate- and Cocaine-negative Urine Samples
Description
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
Time Frame
1 year
Title
The Percentage of Participants Who Are Employed
Description
(# participants employed /divided by total # of participants) x 100
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Percentage of Participants Who Report Injecting Drugs
Description
(# participants reporting injecting drugs /divided by total # of participants) x 100
Time Frame
1 year
Title
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money
Description
(# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100
Time Frame
1 year
Title
The Percentage of Participants Who Report Sharing Injection Equipment
Description
(# participants reporting sharing injection equip/divided by total # of participants) x 100
Time Frame
1 year
Title
The Percentage of Participants With Household Incomes Below the Federal Poverty Level
Description
(# participants with incomes below federal poverty level/divided by total # of participants) x 100
Time Frame
1 year
Title
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
Description
This will be measured after the intervention ends
Time Frame
Year 2
Title
The Percentage of Participants Who Are Employed Post-intervention
Description
This will be measured after the intervention ends
Time Frame
Year 2
Title
The Percentage of Participants Who Report Injecting Drugs Post-intervention
Description
This will be measured after the intervention ends
Time Frame
Year 2
Title
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention
Description
This will be measured after the intervention ends
Time Frame
Year 2
Title
The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention
Description
This will be measured after the intervention ends
Time Frame
Year 2
Other Pre-specified Outcome Measures:
Title
Cost-benefit of Treatment
Description
The Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: report heroin use Exclusion Criteria: report current suicidal or homicidal ideation; have a severe psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be published in a peer-reviewed journal.
Citations:
PubMed Identifier
32086373
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.
Results Reference
derived

Learn more about this trial

The Long-Term Treatment of Drug Addiction and Unemployment

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