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Alcohol Monitor Validation

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ClinicalTrials.gov Identifier: NCT03617705
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Device: Skyn Monitor Lab Session 1 Device: Skyn Monitor Field Test with EMA App Device: Skyn Monitor Lab Session 2 Not Applicable

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). Up to 30 HIV+ and 30 HIV- drinkers will be recruited to validate the Skyn biosensor in both laboratory and real life settings. 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) and BACtrack Mobile Pro breathalyzer, and evaluate its usability and acceptability for daily alcohol monitoring. Also explored will be factors (e.g., gender, viral load) that may be associated with individual differences in biosensor readings (e.g., peak, time-to-peak).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ethanol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HIV+ drinkers
Participants will wear the BACtrack Skyn Alcohol Monitoring Device throughout Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA and Skyn Monitor Lab Session 2 to compare the device readings collected with breath alcohol concentration (BrAC) tests.
 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.
Other Names:
  • BACtrack Skyn
  • Skyn Alcohol Monitoring Device

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.
Other Names:
  • BACtrack Skyn
  • Skyn Alcohol Monitoring Device

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.
Other Names:
  • BACtrack Skyn
  • Skyn Alcohol Monitoring Device
Active Comparator: HIV- drinkers
Participants will wear the BACtrack Skyn Alcohol Monitoring Device throughout Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA and Skyn Monitor Lab Session 2 to compare the device readings collected with breath alcohol concentration (BrAC) tests.
 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.
Other Names:
  • BACtrack Skyn
  • Skyn Alcohol Monitoring Device

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.
Other Names:
  • BACtrack Skyn
  • Skyn Alcohol Monitoring Device

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.
Other Names:
  • BACtrack Skyn
  • Skyn Alcohol Monitoring Device


Outcome Measures
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Primary Outcome Measures :
  1. Transdermal alcohol concentration [ Time Frame: 2 weeks ]
    Assess the validity of the Skyn monitor through comparison with laboratory grade breathalyzer in two fixed-dose lab alcohol administration sessions. The threshold of detection will be defined as the consumption level with a 60% or higher detection rate. Rate of successful detection at the end of 1 beer, 2 beers, and 3 beers will be calculated respectively. This will be done by observing the data series and curves from the monitor readings. Successful detection of consumed alcohol is defined by a TAC peak (e.g., ≥.02g/dL) with a reasonably visible elevation slope for absorption (i.e., TAC curve goes up at a reasonable pace) and a declination slope for elimination (i.e., TAC curve goes down at the reasonable pace).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617705


Contacts
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Contact: Yan Wang, PhD 352-294-5942 ywang48@ufl.edu

Locations
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United States, Florida
HealthStreet Recruiting
Gainesville, Florida, United States, 32608
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Yan Wang, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03617705    
Other Study ID Numbers: IRB201801188-N
1R21AA027191-01 ( U.S. NIH Grant/Contract )
5R21AA027191-02 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021

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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.: Yes
Keywords provided by University of Florida:
alcohol consumption
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs