Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 46 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Missouri, United States ) | NIH, U.S. Fed

Alcohol Impaired Driving: From the Laboratory to the Natural Environment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03846050
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Denis McCarthy, University of Missouri-Columbia

Brief Summary:
This project combined laboratory and ambulatory assessment (AA) methods to test decision making associated with alcohol impaired driving (AID). Participants will complete a laboratory alcohol administration session followed by 6 weeks of mobile assessment. Data from drinking events will be examined to test how individuals make choices about driving or not after consuming alcohol.

Condition or disease Intervention/treatment Phase
Drinking and Driving Behavioral: BAC feedback/warning Behavioral: No BAC feedback/warning Not Applicable

Detailed Description:

Building on laboratory findings from the the PI's (McCarthy) previous work, this project is designed to test AID decision making in both the lab and the natural drinking environment in which AID decisions are made.

Participants complete a laboratory alcohol administration session followed by six weeks of multi-method ambulatory assessment. The ambulatory assessment component will include participant report via smartphone, portable breathalizer (BACtrack), and location and movement data passively collected by the smartphone GPS/accelerometer. The combination of these methods will allow for the integration of subjective (e.g., perceived intoxication) and objective (e.g., BrAC, calculated drinking location) data for each drinking episode.

Aim 1 of the project is to test laboratory measures as prospective predictors of AID and examine the role of event-level influences on specific AID decisions.

Aim 2 of the proposed project is to test the potential for a novel intervention to reduce AID using mobile technology. Participants will be randomly assigned to either a full ambulatory assessment or a minimal assessment control condition. The timing of the introduction of AA will also be manipulated within the full ambulatory assessment condition. This design will allow us to test whether the introduction of ambulatory assessment produces changes in AID behavior, as well as whether such changes persist once ambulatory assessment is discontinued. Changes made to the revised application are aimed at ensuring the achievement of both study aims. If Aim 2 is achieved and ambulatory assessment alters AID behavior, the combination of the minimal assessment control condition and the full assessment condition prior to the introduction of ambulatory assessment has sufficient sample size and power to test Aim 1 hypotheses.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Participants are randomly assigned to 3 conditions, 2 "active" and one control condition. In the active conditions, participants will receive "warning" messages when their BAC reaches a set threshold that it is not safe for them to drive.

The two "Active" conditions differ in the timing of their onset of the intervention.

The control condition will not receive warning and will not report on their driving decision in the moment.

Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Risk for Alcohol Impaired Driving: From the Laboratory to the Natural Environment
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 1, 2022

Arm Intervention/treatment
Experimental: BAC Feedback, immediate onset

Participants will receive a"BAC Feedback/Warning" intervention based on their assessed BAC. Participants in this arm will have a warning presented on their smartphone when they provide a breath sample that indicated their BAC has reached a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.

In this condition, participants will start their 6 week AA portion of their participation immediately after their laboratory session, and will be followed for 6 weeks afterwards.

Comparisons between the two experimental conditions will allow for inferences about the onset and offset of any effects of the "BAC Feedback/Warning" intervention.

Behavioral: BAC feedback/warning
Participants will receive a warning when their BAC reaches a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.

Experimental: BAC Feedback, delayed onset

Participants will receive the "BAC Feedback/Warning" intervention based on their assessed BAC during drinking events.The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.

In this condition, participants will be followed for 6 weeks after their laboratory session prior to starting their 6 week AA portion of their participation.

Comparisons between the two experimental conditions will allow for inferences about the onset and offset of any effects of the "BAC Feedback/Warning" intervention.

Behavioral: BAC feedback/warning
Participants will receive a warning when their BAC reaches a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.

Placebo Comparator: Minimal Assessment Control

Participants will receive the "No BAC Feedback/Warning" intervention. Participants in this condition will complete the laboratory and interview portions of the project. However the AA portion of the project will not contain warning about their BAC (No BAC Feedback/Warning) and will ask fewer questions regarding their AID decisions.

The role of this condition is to provide a baseline comparison of AID behavior for the two active assessment conditions.

Behavioral: No BAC feedback/warning
Participants will receive no information on their current intoxication and will be asked to report less information on their driving decisions.




Primary Outcome Measures :
  1. Alcohol impaired driving behavior [ Time Frame: 12 weeks ]
    Participants will provide self-reported driving behavior (yes/no driven a vehicle) after drinking alcohol during the AA portion. This assessment will be taken from their daily smartphone responses.

  2. Alcohol impaired driving behavior (retrospective) [ Time Frame: 12 weeks ]
    Participants will provide self-reported driving behavior (yes/no driven a vehicle) after drinking alcohol retrospectively during interview sessions. Participants will complete regular phone interview where their daily driving and drinking behavior will be assessed. The outcome measure of interest will be days when participants report driving (yes/no) after consuming alcohol.

  3. Alcohol impaired driving intentions [ Time Frame: 6 weeks ]
    Participants will provide self-reported intentions to drive after drinking alcohol (Would you drive now? Yes/no) from daily assessments during the AA portion of the project.


Secondary Outcome Measures :
  1. Perceived risk of driving [ Time Frame: 6 weeks ]
    Participants will report their perceived risk of driving (1 to 4 scale, "Not Dangerous to Very Dangerous") given their current level of impairment during AA portion of project.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • moderate to heavy drinkers must drive regularly report recent binge drinking fluent in english

Exclusion Criteria:

  • not in treatment for substance use disorder or other psychiatric disorders BMI under 30 no medical conditions contraindicating alcohol consumption

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): NCT03846050


Locations
Layout table for location information
United States, Missouri
University of Missouri-Columbia Recruiting
Columbia, Missouri, United States, 65211
Contact: Christiana Prestigiacomo    573-882-8225    cjpmy5@mail.missouri.edu   
Contact: Denis m mccarthy    573-882-0426    mccarthydm@missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Layout table for additonal information
Responsible Party: Denis McCarthy, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03846050     History of Changes
Other Study ID Numbers: 2008051
R01AA019546 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denis McCarthy, University of Missouri-Columbia:
alcohol impaired driving
decision making
drunk driving
ambulatory assessment

Additional relevant MeSH terms:
Layout table for MeSH terms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs