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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA026605 | 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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Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Group A (Intensive incentives) | Active Comparator | Group A will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will also have the opportunity to earn more incentives for providing negative results. For the first 3 weeks, these additional incentives will scale based on the number of consecutive days of sustained negative samples. For the remaining weeks incentives will be based on a randomized "prize" drawing. |
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| Active Comparator: Group B (Prize-based incentives) | Active Comparator | Group B will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will only have the opportunity to earn more incentives based on a randomized "prize" drawing if they submit a negative sample. |
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| Sham Comparator: Group C (Intensive incentives) | Sham Comparator | Group C serves as a direct control group to Group A and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples. |
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| Sham Comparator: Group D (Price-based incentives) | Sham Comparator | Group D serves as a direct control group to Group B and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pattern of abstinence from alcohol during intervention | Breathalyzer assessments will be collected during the treatment period. This outcome measure will consist of the percentage of days without alcohol use as detected by the breathalyzers. | up to 66 weeks |
| Treatment acceptability | Participant ratings of treatment acceptability on a customized Treatment Acceptability questionnaire will be collected during assessment sessions. Each question will be scored from 1 (low) to 4 (high) and will assess distinct components of the treatment. Questions will be interpreted and scored individually and not be summed together. | A total of 12 assessment sessions spanning over a 66 week period |
| Time to relapse | For this outcome, we will conduct survival analyses to compare relapse across study groups. | A total of 12 assessment sessions spanning over a 66 week period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Healthcare | Lexington | Kentucky | 40514 | United States | ||
| Virginia Tech Carilion |
Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| No Intervention: Group E (no incentives) | No Intervention | Group E will have no monitoring intervention, they will only complete assessment sessions. |
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| Contingency management | Behavioral | Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use. |
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| Roanoke |
| Virginia |
| 24016 |
| United States |