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Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

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ClinicalTrials.gov Identifier: NCT03638596
Recruitment Status : Suspended (Suspended enrollment due to pandemic, follow-up visits still ongoing.)
First Posted : August 20, 2018
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: random 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
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638596


Locations
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United States, Texas
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
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Principal Investigator: Donald M Dougherty, PhD The University of Texas Health Science Center San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03638596    
Other Study ID Numbers: HSC20160425H
5R01AA014988 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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