Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

Drunk Driving Clinical Trial

Official title:

Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638596
• Other study ID #: HSC20160425H
• Secondary ID: 5R01AA014988
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drunk Driving

Intervention

Behavioral:
• Contingency Management
Incentive provided for changing alcohol drinking patterns based on ankle monitor
• Control
Incentive provided is not contingent on alcohol drinking patterns based on ankle monitor

Locations

Country	Name	City	State
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

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