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

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Recruiting

CT.gov ID

NCT05692830

Collaborator

National Institutes of Health (NIH) (NIH)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Alcohol Intoxication	Drug: Alcohol	N/A

Detailed Description

Laboratory Procedures: The aim of the laboratory study is to capture the effect of variable alcohol doses and rates of consumption on the TAC-BAC relationship across individuals in a controlled context. 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 the transdermal reading of the Skyn device. 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 Skyn; 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 Skyn.

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. The Skyn 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 Skyn and their likelihood to adopt a Skyn application.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Participants are counterbalanced into fast or slow consumption condition and 1 of 2 different categories of environmental alcohol tests within gender groups. All subjects will receive the moderate dose of alcohol at visit 1, and be counterbalanced to receive low and high doses between visits 2 and 3. All subjects will complete exercise, environmental alcohol, and body movement interventions across the 3 visits. The order of the post-drink activities will also be counterbalanced.Participants are counterbalanced into fast or slow consumption condition and 1 of 2 different categories of environmental alcohol tests within gender groups. All subjects will receive the moderate dose of alcohol at visit 1, and be counterbalanced to receive low and high doses between visits 2 and 3. All subjects will complete exercise, environmental alcohol, and body movement interventions across the 3 visits. The order of the post-drink activities will also be counterbalanced.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Apr 3, 2022

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fast Condition Participants randomized to consume study beverages at a comparatively rapid rate.	Drug: Alcohol Alcohol administered orally at multiple doses and consumption speeds to test transdermal device accuracy
Experimental: Slow Condition Participants randomized to consume study beverages at a comparatively slow rate.	Drug: Alcohol Alcohol administered orally at multiple doses and consumption speeds to test transdermal device accuracy

Arm

Intervention/Treatment

Experimental: Fast Condition

Participants randomized to consume study beverages at a comparatively rapid rate.

Drug: Alcohol

Alcohol administered orally at multiple doses and consumption speeds to test transdermal device accuracy

Experimental: Slow Condition

Participants randomized to consume study beverages at a comparatively slow rate.

Drug: Alcohol

Alcohol administered orally at multiple doses and consumption speeds to test transdermal device accuracy

Outcome Measures

Primary Outcome Measures

Change in Breath Alcohol Concentration During Laboratory Visits [From beginning to end of alcohol administration visit, measured every ten minutes, up to 12 hours]
change in alcohol concentration through breath provided in the laboratory
Change in Ambulatory Breath Alcohol Concentration [up to 2 weeks]
change in measure of alcohol concentration through breath provided in the field

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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