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Alcohol Monitor Validation

NCT03617705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-06-28

Study results available
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Summary

This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DEVICE

Skyn Monitor Lab Session 1

Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session.

DEVICE

Skyn Monitor Field Test with EMA App

After Skyn Monitor Lab Session 1, participants will be instructed to wear Skyn monitor for the rest of the day and the following two weeks. Participants will also enter information on each drinking session during the two week time using a mobile-based ecological momentary assessment (EMA) to collect real-time data in daily life.

DEVICE

Skyn Monitor Lab Session 2

Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session. Participant will also complete device acceptability and usability survey.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Yan Wang, PhD · University of Florida

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617705 on ClinicalTrials.gov