NCT02722564

Brief Summary

This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. At that time, their BAC level will be measured objectively using a breath alcohol test (BAT) device. The participant will not be told their objective value. This will continue with a verbal estimate and actual BAT reading after every drink until the participant reaches a minimum BAC of 0.10. At this time, participants will continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As their blood alcohol level decreases, the investigators will ask the participant to estimate their level every hour along with an actual reading until reaching 0.08. Statistical analyses will be used to determine how accurate self estimation is in regards to blood alcohol content.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

October 16, 2015

Results QC Date

May 11, 2017

Last Update Submit

May 11, 2017

Conditions

Alcohol Intoxication

Outcome Measures

Primary Outcomes (1)

  • Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device

    The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.

    1 day

Study Arms (1)

all study participants

EXPERIMENTAL

subject will self estimate breath alcohol content and their actual BrAC will be recorded as measured by the Alco Sensor IV after each beer ingested.

Behavioral: self estimation of breath alcohol contentDevice: breath alcohol content as measured by Alco Sensor IV deviceOther: drink a beer

Interventions

self estimation of breath alcohol contentBEHAVIORAL
all study participants
breath alcohol content as measured by Alco Sensor IV deviceDEVICE
all study participants
drink a beerOTHER

drink a beer, repeat until breath alcohol content 0.1

all study participants

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over the legal age (21years old) to drink alcohol.

You may not qualify if:

  • Volunteers will be excluded from the study if they suffer from any of the following conditions:
  • Alcoholism, Diabetes, Kidney/bladder stones, Kidney disease, Liver disease, Stomach ulcer, Organ transplant patients, Dialysis patients, and patients with alcohol allergies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Related Publications (1)

  • Kraus CL, Salazar NC, Mitchell JR, Florin WD, Guenther B, Brady D, Swartzwelder SH, White AM. Inconsistencies between actual and estimated blood alcohol concentrations in a field study of college students: do students really know how much they drink? Alcohol Clin Exp Res. 2005 Sep;29(9):1672-6. doi: 10.1097/01.alc.0000179205.24180.4a.

    PMID: 16205367BACKGROUND

MeSH Terms

Conditions

Alcoholic Intoxication

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Holly Stankewicz, D.O.
Organization
St. Luke's University Health Network
holly.stankewicz@gmail.com
484-526-4000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician and faculty emergency medicine resiency

Study Record Dates

First Submitted

October 16, 2015

First Posted

March 30, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 15, 2017

Results First Posted

May 15, 2017

Record last verified: 2017-05

Locations

US(1)