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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Wearable Alcohol Biosensor?

Research shows that wearable alcohol biosensors like BACtrack Skyn can accurately detect alcohol levels in real-time, with studies demonstrating a 97% accuracy in predicting alcohol consumption episodes. These devices are effective in monitoring alcohol use in natural settings, providing valuable data on intoxication levels and patterns. ^{1 2 3 4 5}

Is the wearable biosensor for alcohol intoxication safe for humans?

The wearable biosensors, like BACtrack Skyn and SCRAM CAM, have been tested for accuracy and tolerability, meaning they are generally safe for humans to use. They are designed to be worn on the wrist and have been evaluated in both laboratory and real-world settings without significant safety concerns. ^{1 2 3 5 6}

How does the wearable biosensor for alcohol intoxication differ from other treatments?

The wearable biosensor, like the BACtrack Skyn, is unique because it continuously monitors alcohol levels through the skin, providing real-time data without the need for blood, breath, or urine samples. This wrist-worn device is compact and integrates with smartphones, offering a more convenient and less intrusive way to track alcohol consumption compared to traditional methods. ^{1 2 5 7 8}

Research Team

Catharine Fairbairn, PhD

Principal Investigator

University of Illinois Urbana-Champaign

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Accuracy of transdermal alcohol monitoring devices in a laboratory setting. [2023]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Signal processing and machine learning with transdermal alcohol concentration to predict natural environment alcohol consumption. [2023]

4. England 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Temporal Dynamics of Transdermal Alcohol Concentration Measured via New-Generation Wrist-Worn Biosensor. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Examining new-generation transdermal alcohol biosensor performance across laboratory and field contexts. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Continuous objective monitoring of alcohol use: twenty-first century measurement using transdermal sensors. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Accuracy of Wearable Transdermal Alcohol Sensors: Systematic Review. [2023]