Wearable Biosensor Accuracy for Alcohol Intoxication

Overseen By Catharine Fairbairn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Must not be taking: Alcohol contraindicated drugs

Disqualifiers: Psychological conditions, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the accuracy of a wearable alcohol biosensor, a device that measures alcohol levels through the skin. Participants will wear this device for 14 days, providing real-world data and attending lab sessions where they consume alcohol at different rates. The goal is to compare how well the device tracks alcohol levels against traditional breathalyzers. This trial suits individuals who drink alcohol at least twice a week and do not have medical conditions that make alcohol consumption unsafe.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance alcohol monitoring technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs or medications that should not be mixed with alcohol.

What prior data suggests that this wearable alcohol biosensor is safe?

Research shows that wearable alcohol sensors, such as the BACtrack Skyn, are generally easy to use. These devices accurately measure alcohol levels by analyzing sweat on the skin, providing a simple, non-invasive way to monitor alcohol use. In past studies, users did not report any major problems from wearing these sensors. The devices track alcohol consumption without interfering with daily activities. While the results are promising, individual experiences with the device may vary. Consider personal comfort and any concerns when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable alcohol biosensor because it offers a non-invasive and continuous way to monitor alcohol intoxication, unlike traditional methods such as breathalyzers or blood tests, which provide only momentary snapshots. This biosensor can be worn comfortably, allowing for real-time tracking of blood alcohol levels over extended periods. Its ability to differentiate between rapid and slow consumption rates adds a new dimension to understanding intoxication dynamics, potentially leading to more personalized and timely interventions.

What evidence suggests that this wearable alcohol biosensor is effective for measuring alcohol intoxication?

This trial will evaluate the accuracy of wearable alcohol biosensors, such as the BACtrack Skyn, in measuring alcohol levels through the skin. Participants will be randomized into two groups: the Fast Condition, where they consume study beverages rapidly, and the Slow Condition, where they consume beverages more slowly. Research has shown that these wearable devices can accurately measure alcohol levels, closely matching traditional breath tests and reliably estimating blood alcohol content (BAC). They have proven very accurate in detecting drinking both in labs and everyday life, offering a new way to monitor alcohol use without a breathalyzer. ^{1 4 6 7 8}

Who Is on the Research Team?

Catharine Fairbairn, PhD

Principal Investigator

University of Illinois Urbana-Champaign

Are You a Good Fit for This Trial?

This trial is for individuals who are at least 21 years old and drink alcohol at least twice a week. It's not suitable for those with medical or psychological conditions that make drinking unsafe, people currently treating an alcohol use disorder, pregnant women, or anyone taking medications that interact badly with alcohol.

Inclusion Criteria

I am 21 years old or older.

Drink alcohol at least 2x weekly

Exclusion Criteria

I am on medication that should not be mixed with alcohol.

Psychological or medical conditions that might contraindicate alcohol-administration

Currently seeking treatment for alcohol use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ambulatory Assessment

Participants engage in ambulatory assessment over 14 days, wearing biosensors and providing breathalyzer readings in real-world contexts.

14 days

Continuous monitoring

Laboratory Sessions

Participants attend three laboratory alcohol-administration sessions at one-week intervals, with alcohol dose and rate of consumption manipulated.

14 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Alcohol Biosensor

Trial Overview

The study tests the accuracy of new wearable biosensors in measuring blood alcohol content (BAC). Participants will wear these sensors over two weeks while providing breathalyzer data during real-world drinking and controlled lab sessions where their drinking amounts vary.

How Is the Trial Designed?

Group I: Slow Condition Experimental Treatment 1 Intervention

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

Group II: Fast Condition Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The BACTrack Skyn alcohol biosensor demonstrated excellent sensitivity for detecting heavy drinking (94%) and good specificity (91%) in a study involving high-risk drinkers, indicating it can accurately monitor alcohol consumption shortly after drinking.

While the Skyn sensor showed favorable tolerability compared to the established SCRAM CAM device, its accuracy declined over time, suggesting that the effectiveness of the device may diminish after several months of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity, specificity, and tolerability of the BACTrack Skyn compared to other alcohol monitoring approaches among young adults in a field-based setting. Ash, GI., Gueorguieva, R., Barnett, NP., et al.[2023]

Wearable transdermal alcohol concentration (TAC) sensors effectively monitor alcohol levels in real-time, providing valuable data on drinking patterns and their potential consequences among young adults, as demonstrated in a study with 222 participants over 5 days.

The study found that specific TAC features, such as peak alcohol concentration and absorption rates, were strong predictors of alcohol-related consequences, highlighting the sensors' ability to offer unique insights beyond traditional self-reported measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal sensor features correlate with ecological momentary assessment drinking reports and predict alcohol-related consequences in young adults' natural settings. Russell, MA., Turrisi, RJ., Smyth, JM.[2023]

The study evaluated the accuracy of two transdermal alcohol sensors (TASs), BACtrack Skyn and Smart Start BARE, on 32 adults after consuming alcohol, finding that both sensors could detect alcohol within 20 minutes but did not match the accuracy of breathalyzers.

While both TASs showed low failure rates (1.7% for Skyn and 4.8% for BARE) and demonstrated some validity in detecting alcohol, they still had significant differences compared to breath alcohol concentration (BrAC) measurements, indicating that further advancements are needed for TASs to be reliable alcohol monitoring tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of transdermal alcohol monitoring devices in a laboratory setting. Brobbin, E., Deluca, P., Coulton, S., et al.[2023]

The BACtrack Skyn prototype, a new wrist-worn transdermal alcohol sensor, showed a significantly shorter lag time in detecting alcohol compared to traditional ankle monitors, with Skyn detecting alcohol 24 minutes after breath alcohol concentration (BrAC) versus 69 minutes for SCRAM devices.

Despite its promising design and faster detection, the Skyn prototype had a higher failure rate (18-38%) compared to the more established SCRAM devices (2%), indicating that further improvements are needed for reliability in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Dynamics of Transdermal Alcohol Concentration Measured via New-Generation Wrist-Worn Biosensor. Fairbairn, CE., Kang, D.[2023]

The new-generation wrist-worn transdermal alcohol sensor, Skyn, shows a significantly lower error rate in estimating Breath Alcohol Concentration (BrAC) compared to older prototypes, with an average error of only 0.007 in laboratory settings and 0.019 in field settings.

These findings suggest that the Skyn device has the potential for accurate alcohol consumption assessment in real-world contexts, although further research with larger participant samples is necessary to fully evaluate its utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining new-generation transdermal alcohol biosensor performance across laboratory and field contexts. Ariss, T., Fairbairn, CE., Bosch, N.[2023]

Transdermal alcohol sensors can reliably measure alcohol consumption over extended periods, providing objective data that correlates well with breath alcohol measurements, although they tend to lag behind by one or more hours.

These sensors can validate self-reported alcohol intake and offer insights into consumption patterns that were previously unavailable, highlighting their potential utility in both research and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous objective monitoring of alcohol use: twenty-first century measurement using transdermal sensors. Leffingwell, TR., Cooney, NJ., Murphy, JG., et al.[2022]

A new software was developed to analyze data from wrist-worn alcohol biosensors, improving the accuracy of detecting alcohol consumption events by correcting data artifacts, which enhanced model performance by 10%.

The machine learning models achieved high accuracy in predicting alcohol consumption, correctly identifying 97% of drinking episodes, indicating that features like the area under the transdermal alcohol concentration curve are crucial for reliable monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signal processing and machine learning with transdermal alcohol concentration to predict natural environment alcohol consumption. Didier, NA., King, AC., Polley, EC., et al.[2023]

A systematic review of 32 studies found that wearable transdermal alcohol sensors generally show moderate to large correlations with traditional alcohol measurement methods like breath and blood tests, indicating their potential for accurate monitoring of alcohol consumption.

However, there is significant variability in the accuracy of these sensors, with sensitivity ranging from 24% to 85.6% and specificity from 67.5% to 92.94%, highlighting the need for more consistent research and direct comparisons between different sensor models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Wearable Transdermal Alcohol Sensors: Systematic Review. Brobbin, E., Deluca, P., Hemrage, S., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9052024/

Accuracy of Wearable Transdermal Alcohol Sensors

The results for transdermal alcohol concentration data from various transdermal alcohol sensors were generally found to positively correlate with breath alcohol ...

2.

humanfactors.jmir.org

humanfactors.jmir.org/2025/1/e64664/

Use of Wearable Transdermal Alcohol Sensors for Monitoring ...

Secondary outcomes suggest that the BACtrack Skyn remains an accurate tool to monitor alcohol consumption compared to self-report data and that ...

3.

skyn.bactrack.com

skyn.bactrack.com/

BACtrack Skyn: BACtrack® Skyn | Wearable Alcohol Biosensor

BACtrack Skyn is designed to measure the alcohol coming from your skin and then estimate your blood alcohol content (BAC) range, in near real-time.

4.

academic.oup.com

academic.oup.com/alcalc/article/59/1/agad068/7328864

Accuracy of transdermal alcohol monitoring devices in a ...

Findings suggest that the two TASs (BACtrack Skyn and SmartStart BARE) recorded significantly similar data postalcohol consumption, but not with ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0741832923002252

Wearable alcohol monitors for alcohol use data collection ...

Models indicated strong transdermal sensor accuracy for real-time drinking detection across both laboratory and field contexts (AUROC, 0.966 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11953609/

Use of Wearable Transdermal Alcohol Sensors for ...

Wearable transdermal alcohol sensor (TAS) devices generate continuous data on alcohol consumption through the indiscernible sweat vapors on the skin.

7.

nature.com

nature.com/articles/s41598-025-16640-y

Development of an alcohol biosensor non-wear algorithm

Wrist-worn alcohol biosensors can continuously track alcohol consumption, but their measurements are disrupted when the device is removed.

8.

tandfonline.com

tandfonline.com/doi/full/10.1080/16066359.2024.2309869

Full article: A qualitative exploration of the experiences of ...

This study aims to assess the acceptability and feasibility of TAS implementation in alcohol services to provide treatment in clinical settings.