Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Suspended
• CT.gov ID: NCT03638596
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 440
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 71
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Drunk Driving	Behavioral: Contingency Management; Behavioral: Control	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: random assignment to treatment and control armsrandom assignment to treatment and control arms
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants
• Actual Study Start Date: May 1, 2017
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent heavy drinking days [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 Outcome Measures

1. Percent drinking days [8-weeks]

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

2. Follow-up percent heavy drinking days [12-months]

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

3. Follow-up percent drinking days [12-months]

   Any self-reported drinks

4. Measurement of alcohol biomarker [Baseline to 8-weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Donald M Dougherty, PhD, The University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT03638596
• Other Study ID Numbers: HSC20160425H; 5R01AA014988
• First Posted: Aug 20, 2018
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The University of Texas Health Science Center at San Antonio: Alcohol Impaired Driving; Driving While Intoxicated; Driving Under the Influence; Driving While Impaired

Study Results

No Results Posted as of May 18, 2022