Evaluating Perceived Fitness to Drive While Intoxicated

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-08

Study Completion Date

2017-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged \> 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving

NCT03335735

Alcohol Drinking Alcohol Intoxication Alcohol Impairment +4 more

COMPLETED NA

Multi-Component Breath Alcohol Intervention

NCT06124898

Alcohol Use Alcohol Drinking Drinking Behavior

ACTIVE_NOT_RECRUITING NA

Breathalyzer Validation Study

NCT04086576

Alcohol Drinking Alcohol Intoxication

COMPLETED NA

Smartphone Technology: Young Adult Drinking

NCT02963818

Alcohol Use Alcohol Drinking Drinking Behavior

COMPLETED PHASE1/PHASE2

Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

NCT01307345

Alcohol Use

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Drinking Alcohol Intoxication Perception, Self Drinking, Alcohol Driving Under the Influence Drinking Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants Blinded to BrAC reading (Control)

Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will complete a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro device.

Group Type NO_INTERVENTION

No interventions assigned to this group

Participants Aware of their BrAC reading

Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will be shown their breath alcohol readings with the BACtrack Mobile Pro device before completing a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.

Group Type EXPERIMENTAL

Participants Shown their Breath Alcohol Content Measurement

Intervention Type BEHAVIORAL

Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Participants Shown their Breath Alcohol Content Measurement

Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 21-39 years old,
* Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months,
* Have consumed at least 4 (women) or 5 (men) drinks on one occasion, in the past year without experiencing adverse effects
* Have a valid photo ID
* Willing and able to use a rideshare credit or septa token as transportation home from the study visit
* Drives at least 2 days per week on average.

Exclusion Criteria

* Desire alcohol treatment now or received it in the past 6 months,
* Have Alcohol use disorder per DSM-V criteria
* Meet or have met criteria for a substance use disorder within the past 12 months per DSM V criteria
* Have a prior psychiatric condition requiring hospitalization
* Are non-English-speaking
* Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol
* Are experiencing suicidal ideation

Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes