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Completed

NCT Number: NCT03617705

Alcohol Monitor Validation

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV+ consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
  • HIV- consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks

Exclusion criteria

  • non-drinkers
  • recent addiction treatment or treatment seeking
  • urine positive for illegal drugs except THC (not applicable to those who are only invited to do field test);
  • past & current alcohol withdrawal
  • severe alcohol use disorder (DSM-5)
  • meeting criteria for current nicotine dependence (not applicable to field only participants) or current substance use disorder (excluding mild cannabis use disorder and mild/moderate alcohol use disorder)
  • medical conditions (other than HIV) contraindicating alcohol
  • pregnancy/breastfeeding in women
  • psychosis or other severe psychiatric conditions.

Treatment and study plan

Skyn Monitor Lab Session 1

Device

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.

Other names: BACtrack Skyn, Skyn Alcohol Monitoring Device

Skyn Monitor Field Test with EMA App

Device

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.

Other names: BACtrack Skyn, Skyn Alcohol Monitoring Device

Skyn Monitor Lab Session 2

Device

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.

Other names: BACtrack Skyn, Skyn Alcohol Monitoring Device

Primary outcomes

  1. Transdermal Alcohol Concentration (TAC)

    Time frame: 2 weeks

    Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2018
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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