Clinical trial NCT05692830: Towards a Wearable Alcohol Biosensor: Examining the Accuracy of BAC Estimates From New-Generation Transdermal Technology Using Large-Scale Human Testing and Machine Learning Algorithms
Official title: Towards a Wearable Alcohol Biosensor: Examining the Accuracy of BAC Estimates From New-Generation Transdermal Technology Using Large-Scale Human Testing and Machine Learning Algorithms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcohol Drinking
Alcohol Intoxication
Keywords: transdermal alcohol content
ambulatory
transdermal biosensor
machine learning algorithms
breath alcohol content
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-01-20
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regular healthy drinkers aged 21+

Brief summary: The study will employ a combined laboratory-ambulatory design. Participants will engage in ambulatory assessment over the course of 14 days, wearing biosensors assessing transdermal alcohol concentration (TAC) and providing breathalyzer readings in real-world contexts. Also during this period, participants will attend three laboratory alcohol-administration sessions scheduled at one-week intervals, with alcohol dose and rate of consumption manipulated within and between participants, respectively. Laboratory visits will also double as ambulatory orientation, check-in, and close-out sessions.

Detailed description: Laboratory Procedures: The aim of the laboratory study is to capture variability in the TAC-BAC relationship across individuals in a controlled context, featuring manipulations theorized to confound transdermal measurements of BAC and so ensuring adequate variability in these factors in the broader dataset. Laboratory alcohol-administration sessions will be held at one-week intervals, scheduled at study initiation (day 0), study midpoint (day 7), and study end (day 14).

Alcohol-administration procedures will employ a within (alcohol dose) X between (rate of consumption) participant design. All participants will consume three doses of alcohol over the course of the three laboratory sessions, targeting peak blood alcohol concentration (BAC) levels of .03%, .06%, and .09% respectively. The order of alcohol doses will be counterbalanced across participants. The exact quantity of alcohol administered to each participant in order to achieve these target peak BACs will be calculated based on individualized formulas adjusting for drinking rate, sex, height, weight, and age (see formulas provided in Watson et al., (1981)). Rate of consumption will be manipulated between participants, with equal numbers of participants assigned to consume alcohol at relatively "fast" and "slow" rates. Beverage intake will be monitored to ensure participant comfort and even consumption across the beverage administration period. After beverage administration, participants will provide breath alcohol concentration (BrAC) readings at 10- min intervals.

In addition, during the laboratory procedures, participants will be exposed to environmental factors that are known to impact readings taken by transdermal sensors. These manipulations will allow the research team to train the machine learning algorithm to recognize and model for these environmental effects. These manipulations include: 1) Environmental alcohol: common household products containing alcohol (e.g., hand sanitizer, perfume, lotion containing alcohol) will be sprayed or applied in proximity to the transdermal sensor; 2) Sweating: Participants will be asked to engage in a brief 10-30 minute aerobic exercise while in a seated position (i.e., stationary biking) while under the supervision of a research assistant. This brief exercise will be designed simply to yield exertion to the point of sweating and not exertion beyond this point; 3) Arm Movements: Participants will be asked to engage in isolated body movements (e.g., arms and feet) to determine whether device shifting caused by such movements impact readings taken by transdermal sensors.

Ambulatory Procedures: This arm of the study aims to capture the TAC-BAC relationship among participants drinking in everyday settings. Ambulatory assessment will take place over 14 days. During laboratory session 1, prior to beverage administration, participants will be oriented to ambulatory study procedures. One or more transdermal device will be worn throughout participation. During orientation, participants will be trained to use the mobile breathalyzer. To avoid contamination of breathalyzer readings by mouth alcohol, participants will be instructed to wait 5 minutes after their last sip of alcohol to provide a reading. Also during this orientation session, participants will receive training in standard drink reporting (used to validate breathalyzer readings). During ambulatory assessment, participants will provide breathalyzer readings in response to both random and user-initiated prompts via their smartphones. On day 14 of the study, participants will attend a final laboratory session during which they will return study equipment as well as complete questionnaires asking them to reflect on their experience using the transdermal sensors and their likelihood to adopt a transdermal sensor application.

Eligibility criteria: Inclusion Criteria:

* 21 years or older
* drink alcohol at least 2x weekly

Exclusion Criteria:

* psychological or medical conditions that might contraindicate alcohol-administration
* history of adverse reaction to type and amount of beverage used in the study
* currently seeking treatment for alcohol use disorder
* does not drink alcohol regularly
* taking drugs or medications for which alcohol consumption would be contraindicated
* women who are pregnant or are attempting to become pregnant

Primary outcomes:
measure: Transdermal estimates of alcohol consumption
timeFrame: Across the 14 day period of the study
measure: Transdermal estimates of drinking risk level
timeFrame: Across the 14 day period of the study
measure: Transdermal estimates of blood alcohol concentration
timeFrame: Across the 14 day period of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Catharine Fairbairn, PhD
role: PRINCIPAL_INVESTIGATOR
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