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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA024101 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for alcohol and drug addiction and can maintain 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. Investigators' research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide alcohol- or drug-free urine samples to maintain maximum pay, can maintain alcohol and drug abstinence. Now investigators need to develop effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. Investigators are proposing to 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 and alcohol abstinence. The intervention will combine 3 elements -- 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 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 drug abstinence. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to a Usual Care Control group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. Usual Care Control participants will be offered counseling and referrals to employment and treatment programs. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. This novel intervention could be an effective and economically sound way to promote long-term employment and drug abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPS Plus Abstinence-Contingent Wage Supplement | Experimental | Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment. |
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| Usual Care Control | No Intervention | Counseling and referrals to employment and treatment programs. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPS Plus Abstinence-Contingent Wage Supplement | Behavioral | Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Abstinence | Percentage of participants abstinent per month | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Employment | Percentage of participants employed per month | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Silverman, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Learning and Health | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37541600 | Derived | Novak MD, Toegel F, Holtyn AF, Rodewald AM, Arellano M, Baranski M, Barnett NP, Leoutsakos JM, Fingerhood M, Silverman K. Abstinence-contingent wage supplements for adults experiencing homelessness and alcohol use disorder: A randomized clinical trial. Prev Med. 2023 Nov;176:107655. doi: 10.1016/j.ypmed.2023.107655. Epub 2023 Aug 3. |
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This was a two-group randomized clinical trial. All participants completed a 1-month Phase 1 Induction and Initiation period and were then randomly assigned to an intervention or control group. After random assignment, participants completed a 6-month Phase 2 Intervention period and completed study assessments every month.
Participants were recruited from treatment clinics and recovery houses serving adults with alcohol use disorder, online job boards, and through compensated referrals by participants. Participants were recruited from 2 January 2019 through 5 March 2020 and from 29 October 2020 through 12 May 2022. The pause in recruitment was due to regional and institutional restrictions related to the COVID-19 pandemic. Most of the study was conducted remotely because of the COVID-19 pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | IPS Plus Abstinence-Contingent Wage Supplement | Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment. IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. |
| FG001 | Usual Care Control | Counseling and referrals to employment and treatment programs. |
| FG002 | Induction Period | During the first week, participants were introduced to the workplace contingencies: they could earn $5 per hour for up to 4 h per day for contacting research staff each day. Participants who contacted research staff 4 out of 5 days during the first week were invited to continue. During the next 3 weeks, participants were given a TAC monitoring device and could earn $8 per hour for up to 4 h per day each weekday. These devices had different requirements for use, which made it necessary for the procedures to be tailored to the device used. The SCRAM device requires that participants provide an alcohol-negative breath sample prior to use. Because participants had to be abstinent from alcohol to begin using SCRAM, participants fitted with SCRAM devices could maintain maximum pay if they continued abstaining from alcohol use. If alcohol use was detected, pay was reset to $1 per hour. After being reset, pay rates could be raised by $1 per hour (up to $8 per hour) for each day without alcohol use. The BACtrack Skyn device does not require that participants provide an alcohol-negative breath sample to begin using the device. So, incentives for alcohol abstinence were not provided during the Induction period for participants fitted with BACtrack Skyn. Instead, incentives were provided for wearing the device each day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, Phase 1 |
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| Period 2, Phase 2 |
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Only randomized participants were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | IPS Plus Abstinence-Contingent Wage Supplement | Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment. IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Abstinence | Percentage of participants abstinent per month | Intent to treat | Posted | Number | percentage of participants | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IPS Plus Abstinence-Contingent Wage Supplement | Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment. IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | Johns Hopkins University | 4436176051 | ksilverm@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2023 | May 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007296 | Myo-Inositol-1-Phosphate Synthase |
| ID | Term |
|---|---|
| D019753 | Intramolecular Lyases |
| D007535 | Isomerases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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|
| NOT COMPLETED |
|
| BG001 | Usual Care Control | Counseling and referrals to employment and treatment programs. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Usual Care Control | Counseling and referrals to employment and treatment programs. |
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|
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| Secondary | Employment | Percentage of participants employed per month | intent-to-treat | Posted | Number | percentage of participants | 1 year |
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|
|
|
| 0 |
| 62 |
| 3 |
| 62 |
| 0 |
| 62 |
| EG001 | Usual Care Control | Counseling and referrals to employment and treatment programs. | 0 | 57 | 3 | 57 | 0 | 57 |
| Cancer | General disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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