Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03846050 |
| Other study ID # |
2008051 |
| Secondary ID |
R01AA019546 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2018 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Missouri-Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
