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Completed

NCT Number: NCT03638596

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.

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Key information

Conditions

Drunk Driving Behavior Criminal Behavior Dangerous Behavior Driving Under the Influence

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

Incentive provided for changing alcohol drinking patterns based on ankle monitor

Control

Behavioral

Incentive provided is not contingent on alcohol drinking patterns based on ankle monitor

Primary outcomes

  1. Percent heavy drinking days

    Time frame: 8-weeks

    Percent of days with estimated breath alcohol concentration .08% or higher or self-reported drinks > 5 for men and > 4 for women

Secondary outcomes

  1. Percent drinking days

    Time frame: 8-weeks

    Percent of days with any positive transdermal alcohol concentration >.02 or any self-reported drinks

  2. Follow-up percent heavy drinking days

    Time frame: 12-months

    Self-reported drinks > 5 for men and > 4 for women

  3. Follow-up percent drinking days

    Time frame: 12-months

    Any self-reported drinks

  4. Measurement of alcohol biomarker

    Time frame: Baseline to 8-weeks

    Change in phosphatidylethanol (PEth) using an assay on a blood sample

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Aug 20, 2018
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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