An interventional study of Abstinence-contingent wage supplements and Individual Placement and Support (IPS) supported employment in Substance Abuse, Intravenous, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 91 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Behavioral: 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.
Behavioral: Abstinence-contingent wage supplements · Behavioral: Individual Placement and Support (IPS) supported employment
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 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.
The Percentage of Opiate- and Cocaine-negative Urine Samples
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
Time frame: 1 year
The Percentage of Participants Who Are Employed
(# participants employed /divided by total # of participants) x 100
Time frame: 1 year
The Percentage of Participants Who Report Injecting Drugs
(# participants reporting injecting drugs /divided by total # of participants) x 100
Time frame: 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
Time frame: 1 year
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
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
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
This will be measured after the intervention ends
Time frame: Year 2
The Percentage of Participants Who Are Employed Post-intervention
This will be measured after the intervention ends
Time frame: Year 2
The Percentage of Participants Who Report Injecting Drugs Post-intervention
This will be measured after the intervention ends
Time frame: 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
Time frame: Year 2
The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention
This will be measured after the intervention ends
Time frame: Year 2
Cost-benefit of Treatment
The Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs
Time frame: 2 years
| Milestone | IPS Only | IPS Plus Wage Supplement |
|---|---|---|
| Started | 47 | 44 |
| Completed | 47 | 44 |
| Not completed | 0 | 0 |
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
| percentage of urine samples | IPS Only | IPS Plus Wage Supplement |
|---|---|---|
| The Percentage of Opiate- and Cocaine-negative Urine Samples | 44.9 (0 to 100) | 64.6 (0 to 100) |
(# participants employed /divided by total # of participants) x 100
| percentage of participants | IPS Only | IPS Plus Wage Supplement |
|---|---|---|
| The Percentage of Participants Who Are Employed | 27.7 | 59.1 |
(# participants reporting injecting drugs /divided by total # of participants) x 100
Results for this outcome have not been posted.
(# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100
Results for this outcome have not been posted.
(# participants reporting sharing injection equip/divided by total # of participants) x 100
Results for this outcome have not been posted.
(# participants with incomes below federal poverty level/divided by total # of participants) x 100
Results for this outcome have not been posted.
This will be measured after the intervention ends
Results for this outcome have not been posted.
This will be measured after the intervention ends
Results for this outcome have not been posted.
This will be measured after the intervention ends
Results for this outcome have not been posted.
This will be measured after the intervention ends
Results for this outcome have not been posted.
This will be measured after the intervention ends
Results for this outcome have not been posted.
The Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IPS Only | 4/47 (8.5%) | 8/47 (17%) | 11/47 (23.4%) |
| IPS Plus Wage Supplement | 5/44 (11.4%) | 5/44 (11.4%) | 8/44 (18.2%) |
| Event | IPS Only | IPS Plus Wage Supplement |
|---|---|---|
| DeathGeneral disorders | 4/47 | 5/44 |
| leg amputatedMusculoskeletal and connective tissue disorders | 1/47 | 0/44 |
| kidney failureRenal and urinary disorders | 1/47 | 0/44 |
| strokeNervous system disorders | 1/47 | 0/44 |
| upper respiratory problemRespiratory, thoracic and mediastinal disorders | 1/47 | 0/44 |
| abdominal painGastrointestinal disorders | 1/47 | 0/44 |
| Event | IPS Only | IPS Plus Wage Supplement |
|---|---|---|
| pneumoniaRespiratory, thoracic and mediastinal disorders | 3/47 | 0/44 |
| depressionPsychiatric disorders | 2/47 | 2/44 |
| foot painMusculoskeletal and connective tissue disorders | 0/47 | 2/44 |
| psychiatric treatmentPsychiatric disorders | 1/47 | 1/44 |
| bumped eyeEye disorders | 0/47 | 1/44 |
| respiratory infectionInfections and infestations | 0/47 | 1/44 |
| seizureNervous system disorders | 0/47 | 1/44 |
| vomitingGastrointestinal disorders | 0/47 | 1/44 |
| chest painRespiratory, thoracic and mediastinal disorders | 1/47 | 0/44 |
| coughRespiratory, thoracic and mediastinal disorders | 1/47 | 0/44 |
| Age, Categorical(Participants) | IPS Only | IPS Plus Wage Supplement | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 44 | 89 |
| >=65 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | IPS Only | IPS Plus Wage Supplement | Total |
|---|---|---|---|
| Female | 20 | 21 | 41 |
| Male | 27 | 23 | 50 |
| Ethnicity (NIH/OMB)(Participants) | IPS Only | IPS Plus Wage Supplement | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 46 | 38 | 84 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Race (NIH/OMB)(Participants) | IPS Only | IPS Plus Wage Supplement | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 23 | 28 | 51 |
| White | 22 | 14 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(Participants) | IPS Only | IPS Plus Wage Supplement | Total |
|---|---|---|---|
| United States | 47 | 44 | 91 |
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Plan to share: No — The data will be published in a peer-reviewed journal.
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