NCT03617705

Alcohol Monitor Validation

Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The overarching goal of this research program is to improve alcohol intervention and eventually related clinical outcomes (e.g., liver function) among HIV+ drinkers through biosensor-assisted intervention. Research shows HIV infection can influence alcohol metabolism (i.e., higher blood alcohol levels), so it's necessary to validate the new alcohol biosensor in HIV+ drinkers rather than in general population. The primary goal of this project, as a step toward the development and evaluation of a biosensor-assisted alcohol intervention, is to validate the newly available wrist worn transdermal alcohol biosensor (BACtrack Skyn). The two specific aims are: (1) To assess validity and reliability of the Skyn biosensor using fixed-dose lab administration of alcohol through comparison with laboratory grade breathalyzer, and (2) To validate Skyn biosensor in daily life using a 2-week ecological momentary assessment (EMA) to compare self-reported drinking and the Skyn derived transdermal alcohol concentration (TAC) readings.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-08-06
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study