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The Long-Term Treatment of Drug Addiction and Unemployment

The Long-Term Treatment of Drug Addiction and Unemployment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02487745
Enrollment
91
Registered
2015-07-01
Start date
2015-11-30
Completion date
2020-09-30
Last updated
2022-08-11

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

Conditions

Substance Abuse, Intravenous

Keywords

Cocaine, Methadone, Employment, Opioids

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.

Interventions

BEHAVIORALAbstinence-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.

BEHAVIORALIndividual 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.

Sponsors

National Institute on Drug Abuse (NIDA)
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 No maximum
Healthy volunteers
No

Inclusion criteria

* report heroin use

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The Percentage of Participants Who Are Employed1 year(# participants employed /divided by total # of participants) x 100
The Percentage of Opiate- and Cocaine-negative Urine Samples1 year(# opiate- and cocaine-negative urine samples/divided by possible #) x 100

Secondary

MeasureTime frameDescription
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money1 year(# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100
The Percentage of Participants Who Report Sharing Injection Equipment1 year(# participants reporting sharing injection equip/divided by total # of participants) x 100
The Percentage of Participants With Household Incomes Below the Federal Poverty Level1 year(# participants with incomes below federal poverty level/divided by total # of participants) x 100
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-interventionYear 2This will be measured after the intervention ends
The Percentage of Participants Who Report Injecting Drugs Post-interventionYear 2This will be measured after the intervention ends
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-interventionYear 2This will be measured after the intervention ends
The Percentage of Participants Who Report Sharing Injection Equipment Post-interventionYear 2This will be measured after the intervention ends
The Percentage of Participants Who Are Employed Post-interventionYear 2This will be measured after the intervention ends
The Percentage of Participants Who Report Injecting Drugs1 year(# participants reporting injecting drugs /divided by total # of participants) x 100

Other

MeasureTime frameDescription
Cost-benefit of Treatment2 yearsThe Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs

Countries

United States

Participant flow

Pre-assignment details

Participants were enrolled in a 3-month abstinence initiation phase (Phase 1) prior to random assignment.

Participants by arm

ArmCount
IPS Only
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment. 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.
47
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. 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. 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.
44
Total91

Baseline characteristics

CharacteristicIPS OnlyIPS Plus Wage SupplementTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants0 Participants2 Participants
Age, Categorical
Between 18 and 65 years
45 Participants44 Participants89 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants38 Participants84 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
23 Participants28 Participants51 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants4 Participants
Race (NIH/OMB)
White
22 Participants14 Participants36 Participants
Region of Enrollment
United States
47 Participants44 Participants91 Participants
Sex: Female, Male
Female
20 Participants21 Participants41 Participants
Sex: Female, Male
Male
27 Participants23 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 475 / 44
other
Total, other adverse events
11 / 478 / 44
serious
Total, serious adverse events
8 / 475 / 44

Outcome results

Primary

The Percentage of Opiate- and Cocaine-negative Urine Samples

(# opiate- and cocaine-negative urine samples/divided by possible #) x 100

Time frame: 1 year

Population: Intent-to-treat

ArmMeasureValue (MEAN)
IPS OnlyThe Percentage of Opiate- and Cocaine-negative Urine Samples44.9 percentage of urine samples
IPS Plus Wage SupplementThe Percentage of Opiate- and Cocaine-negative Urine Samples64.6 percentage of urine samples
p-value: 0.05Regression, Logistic
Primary

The Percentage of Participants Who Are Employed

(# participants employed /divided by total # of participants) x 100

Time frame: 1 year

ArmMeasureValue (NUMBER)
IPS OnlyThe Percentage of Participants Who Are Employed27.7 percentage of participants
IPS Plus Wage SupplementThe Percentage of Participants Who Are Employed59.1 percentage of participants
p-value: 0.05Regression, Logistic
Secondary

The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention

This will be measured after the intervention ends

Time frame: Year 2

Secondary

The Percentage of Participants Who Are Employed Post-intervention

This will be measured after the intervention ends

Time frame: Year 2

Secondary

The Percentage of Participants Who Report Injecting Drugs

(# participants reporting injecting drugs /divided by total # of participants) x 100

Time frame: 1 year

Secondary

The Percentage of Participants Who Report Injecting Drugs Post-intervention

This will be measured after the intervention ends

Time frame: Year 2

Secondary

The Percentage of Participants Who Report Sharing Injection Equipment

(# participants reporting sharing injection equip/divided by total # of participants) x 100

Time frame: 1 year

Secondary

The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention

This will be measured after the intervention ends

Time frame: Year 2

Secondary

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

Time frame: 1 year

Secondary

The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention

This will be measured after the intervention ends

Time frame: Year 2

Secondary

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

Time frame: 1 year

Other Pre-specified

Cost-benefit of Treatment

The Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs

Time frame: 2 years

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026