Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

Study Overview
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Brief Summary
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The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.

Detailed Description
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Individuals who have a drunk driving arrest and are at risk for ongoing heavy drinking will be recruited to test the efficacy of contingency management for reducing alcohol use and identifying mechanisms of change. We will recruit those arrested for drunk driving offenses, ≥ 21 years of age, who at risk for ongoing heavy alcohol use and randomize them to one of two groups: control or a contingency management. Participants experience 8 weekly assessments of current alcohol use and other variables associated with changes in alcohol use. Post-intervention, participants will return to the laboratory once per month at 3, 6, 9, and 12 months post-study entry for follow-up procedures to determine the mechanisms of drinking behavior change.

Official Title
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Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

Conditions
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Drunk Driving

Intervention / Treatment
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* Behavioral: Contingency Management
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: arrested for drunk driving offense Exclusion Criteria: significant alcohol withdrawal symptoms medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery) inability to comprehend the informed consent process or study instructions presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium incarceration

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: random assignment to treatment and control arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management<br>Incentive delivery contingent upon maintaining transdermal alcohol concentration below cut-off | Behavioral: Contingency Management<br>* Incentive provided for changing alcohol drinking patterns based on ankle monitor<br>|
| Placebo Comparator: Control<br>Incentive delivery not contingent on transdermal alcohol concentration | Behavioral: Control<br>* Incentive provided is not contingent on alcohol drinking patterns based on ankle monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent heavy drinking days | Percent of days with estimated breath alcohol concentration .08% or higher or self-reported drinks > 5 for men and > 4 for women | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent drinking days | Percent of days with any positive transdermal alcohol concentration >.02 or any self-reported drinks | 8-weeks | 
| Follow-up percent heavy drinking days | Self-reported drinks > 5 for men and > 4 for women | 12-months | 
| Follow-up percent drinking days | Any self-reported drinks | 12-months | 
| Measurement of alcohol biomarker | Change in phosphatidylethanol (PEth) using an assay on a blood sample | Baseline to 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Impaired Driving, Driving While Intoxicated, Driving Under the Influence, Driving While Impaired