Alcohol Drinking Clinical Trial
Official title:
Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults
NCT number | NCT05028413 |
Other study ID # | 827284 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2017 |
Est. completion date | June 23, 2017 |
Verified date | January 2022 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 23, 2017 |
Est. primary completion date | June 23, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 39 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants' Perceived Fitness to Drive Measurement | Participant's self rating on visual analog scale from 1-10 (1: Extremely Able to Drive; 10: Not at all Able to Drive) after each Breath Alcohol Content Measurement collected | The duration of study visit, up to 8 hours | |
Secondary | Participants' Perceived Willingness to Drive Measurement | Participant's self rating on visual analog scale from 1-10 (1: Not at all Willing to Drive; 10: Extremely Willing to Drive) after each Breath Alcohol Content Measurement collected | The duration of study visit, up to 8 hours |
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