Alcohol Monitor Validation

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617705
• Other study ID #: IRB201801188-N
• Secondary ID: R21AA027191
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	HealthStreet	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transdermal Alcohol Concentration (TAC)	Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.	2 weeks