Clinical trial NCT03846050: Alcohol Impaired Driving: From the Laboratory to the Natural Environment
Official title: Risk for Alcohol Impaired Driving: From the Laboratory to the Natural Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drinking and Driving
Keywords: alcohol impaired driving
decision making
drunk driving
ambulatory assessment
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-02-19
Enrollment: 230
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Alcohol impaired driving behavior
timeFrame: 12 weeks
measure: Alcohol impaired driving behavior (retrospective)
timeFrame: 12 weeks
measure: Alcohol impaired driving intentions
timeFrame: 6 weeks
Secondary outcomes:
measure: Perceived risk of driving
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References:
citation: Haney AM, Motschman CA, Warner OM, Wesley RL, Wycoff AM, Trull TJ, McCarthy DM. Comparing associations between mood and breath alcohol concentration in the laboratory and natural environment. Psychol Addict Behav. 2022 Nov;36(7):885-894. doi: 10.1037/adb0000814. Epub 2022 Feb 7.