search
Back to results

Alcohol Monitor Validation

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skyn Monitor Lab Session 1
Skyn Monitor Field Test with EMA App
Skyn Monitor Lab Session 2
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Human Immunodeficiency Virus (HIV) focused on measuring alcohol consumption

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • HealthStreet
  • University of Florida

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All participants (HIV+ and HIV- drinkers)

Arm Description

All participants were planned to complete the BACtrack Skyn biosensor in two lab sessions, and wear the Skyn biosensor for two weeks in the field. However, due to COVID, not all participants were able to complete the lab sessions.

Outcomes

Primary Outcome Measures

Transdermal Alcohol Concentration (TAC)
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2018
Last Updated
June 27, 2023
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03617705
Brief Title
Alcohol Monitor Validation
Official Title
Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
alcohol consumption

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All participants (HIV+ and HIV- drinkers)
Arm Type
Other
Arm Description
All participants were planned to complete the BACtrack Skyn biosensor in two lab sessions, and wear the Skyn biosensor for two weeks in the field. However, due to COVID, not all participants were able to complete the lab sessions.
Intervention Type
Device
Intervention Name(s)
Skyn Monitor Lab Session 1
Other Intervention Name(s)
BACtrack Skyn, Skyn Alcohol Monitoring Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Skyn Monitor Field Test with EMA App
Other Intervention Name(s)
BACtrack Skyn, Skyn Alcohol Monitoring Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Skyn Monitor Lab Session 2
Other Intervention Name(s)
BACtrack Skyn, Skyn Alcohol Monitoring Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transdermal Alcohol Concentration (TAC)
Description
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthStreet
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Alcohol Monitor Validation

We'll reach out to this number within 24 hrs