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.

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

Alcohol Drinking

Alcohol Intoxication

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 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.

Alcohol

We will assess the accuracy of transdermal estimates of drinking vs sobriety

We will assess the accuracy of transdermal estimates of high risk drinking vs low risk
drinking and sobriety

We will assess the accuracy of transdermal estimates of blood alcohol concentration (BAC)

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status