Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03503396 |
Other study ID # |
2010187 |
Secondary ID |
R01AA019546-06A1 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2, 2018 |
Est. completion date |
January 20, 2019 |
Study information
Verified date |
April 2023 |
Source |
University of Missouri-Columbia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a pilot study to set up a larger investigation examining predictors of the decision
to drive after consuming alcohol. All participants will carry a study provided smartphone and
breathalyzer device for the 2 week period of the study. The intervention is that participants
are randomly assigned to one of 2 breathalyzer feedback conditions - one where they receive a
warning that their results indicate they should not drive and one where they receive no
feedback. The study is designed to provide information needed for a larger version with a
similar protocol, but also to provide an initial test of project hypotheses as well.
Description:
Despite previous success in reducing alcohol impaired driving (AID) and fatal crashes, rates
have not decreased significantly since the 1990s. Developing novel approaches to
prevention/intervention are likely required to produce further progress.
This project is designed to evaluate a potential intervention for AID using mobile
technology. In addition, the project is designed to provide pilot data for a large scale
investigation.
Recent laboratory work by the PI has demonstrated the utility of assessing AID risk factors
when participants are intoxicated. We identified four risk factors that, measured under
intoxication, are cross-sectional predictors of AID: AID attitudes (Morris et al., 2014),
impulsivity (McCarthy et al., 2012), behavioral economic demand (Amlung et al., 2016) and
subjective intoxication (Amlung et al., 2014).
The proposed project will evaluate these factors as prospective predictors of AID and extend
this work outside the laboratory and into participants' natural drinking environment using
Ambulatory Assessment (AA). AA is a set of techniques used to collect data from individuals
in the course of their daily life. AA methods provide increased ecological validity across
multiple modalities (e.g., self-report, physiological measures). No study to date has used AA
to examine AID. We will employ a combination of three AA methods: ecological momentary
assessment, geospatial technology, and portable breath analysis.
Ecological Momentary Assessment (EMA) is a form of AA that allows participants to self-report
on their current thoughts, feelings, and behaviors in their natural environment (Shiffman et
al., 2008). EMA avoids most pitfalls of retrospective reports, and is increasingly used to
study temporally proximal influences on substance use behaviors (Shiffman, 2009). Despite the
importance of such influences to AID decisions (Quinn & Fromme, 2012), no study to date has
applied EMA methods to the study of AID.
Advancements in mobile technology, such as global position systems (GPS) and portable
breathalizers, allow for the collection of objective data on participant location and alcohol
use in real-time. We will combine location data (e.g., drinking venue, distance from home)
and in-the-moment breathalyzer data with self-report EMA data from each participant drinking
episode. This combination will allow for a more complete assessment of event-level factors
that contribute to AID decisions.
This pilot project will test the hypothesis that temporally proximal measures of AID risk
factors (subjective impairment, perceived risk) collected during a drinking episode will
improve prediction of AID, over and above trait measures of AID risk factors.
The pilot project will also test the potential for AA to function as an intervention for AID.
In this pilot, participants will be randomly assigned to either receive some feedback from
their breathalyzer (a warning that they have consumed too much to drive safely) or not to
receive any feedback. Note that participants will not be told their BAC, due to potential
risks of specific feedback (increased consumption, titrating drinking to drive at slightly
below .08). Instead, feedback will be general ("Your results indicate that you have drank too
much to drive safely"), and participants will not be aware of what BAC triggers these
warnings.
Comparisons of all participants AID behavior at baseline (from a Timeline Follow-back
assessment) with their AID behavior during study participation will be used to test whether
the increased self-monitoring of AA can alter AID decisions. In addition, comparisons between
groups (feedback vs. none) will test for potential effects of BAC feedback on AID decisions.
Support for these hypotheses could lead to novel, cost-effective interventions to reduce AID
using mobile technology.
This pilot will enroll 40 moderate-to-heavy drinking young adults. Participants will complete
a brief laboratory session of AID risk measures, followed by two weeks of AA. They will be
randomly assigned to one of two conditions (BAC feedback vs. none). Interview assessments of
AID will be conducted at baseline and at the completion of AA assessments, with interviewers
blind to condition.