Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

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.

Study Overview

• Status: Completed
• Conditions: Drunk Driving
• Intervention / Treatment: Behavioral: Contingency Management; Behavioral: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Nathalie Hill-Kapturczak, PhD, The University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Driving Under the Influence; Alcohol Impaired Driving; Driving While Intoxicated; Driving While Impaired
• Other Study ID Numbers: HSC20160425H; 5R01AA014988 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No