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Alcohol DrinkingNCT05692830

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

An observational study of Alcohol Drinking and Alcohol Intoxication, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Drinking, Alcohol Intoxication
What is being tested?
Alcohol
Type of treatment
Pill or oral medicine
How many people
240 participants
Where
1 siteUnited States
Study dates
22 Oct 2022to 1 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Regular healthy drinkers aged 21+

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Catharine Fairbairn, PhD contact

217-300-5850

uiucalcohollab@gmail.com

United States1 site, 1 recruiting
  • University of Illinois at Urbana-Champaign

    Champaign, Illinois, 61820

    Catharine E Fairbairn, Ph.D., 217 300 5850, uiucalcohollab@gmail.com

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Since initial record creation, the study start date has been updated to conform to current ICMJE pre-registration requirements. Only participants recruited subsequent, and not prior to, this updated initiation date are included in reports from the main trial.

Being tested
Alcohol
Keywords
transdermal alcohol content, ambulatory, transdermal biosensor, machine learning algorithms, breath alcohol content
Medical subject headings
Alcohol Drinking, Alcoholic Intoxication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlcoholDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transdermal estimates of alcohol consumption

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

    Measured: Across the 14 day period of the study

  2. Transdermal estimates of drinking risk level

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

    Measured: Across the 14 day period of the study

  3. Transdermal estimates of blood alcohol concentration

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

    Measured: Across the 14 day period of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start22 Oct 2022
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692830
Sponsor's protocol ID
AA028488-01A1
Status last verified
Aug 2025
First submitted
20 Oct 2022
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • White AM. What happened? Alcohol, memory blackouts, and the brain. Alcohol Res Health. 2003;27(2):186-96.

    PubMed 15303630
  • Leffingwell TR, Cooney NJ, Murphy JG, Luczak S, Rosen G, Dougherty DM, Barnett NP. Continuous objective monitoring of alcohol use: twenty-first century measurement using transdermal sensors. Alcohol Clin Exp Res. 2013 Jan;37(1):16-22. doi: 10.1111/j.1530-0277.2012.01869.x. Epub 2012 Jul 23.

    PubMed 22823467
  • Alessi SM, Barnett NP, Petry NM. Experiences with SCRAMx alcohol monitoring technology in 100 alcohol treatment outpatients. Drug Alcohol Depend. 2017 Sep 1;178:417-424. doi: 10.1016/j.drugalcdep.2017.05.031. Epub 2017 Jun 28.

    PubMed 28709081
  • Fairbairn CE, Kang D, Bosch N. Using machine learning for real-time BAC estimation from a new-generation transdermal biosensor in the laboratory. Drug Alcohol Depend. 2020 Nov 1;216:108205. doi: 10.1016/j.drugalcdep.2020.108205. Epub 2020 Aug 1.

    PubMed 32853998
  • Kerr WC, Patterson D, Koenen MA, Greenfield TK. Alcohol content variation of bar and restaurant drinks in Northern California. Alcohol Clin Exp Res. 2008 Sep;32(9):1623-9. doi: 10.1111/j.1530-0277.2008.00741.x. Epub 2008 Jul 8.

    PubMed 18616674
  • Mohan AMV, Windmiller JR, Mishra RK, Wang J. Continuous minimally-invasive alcohol monitoring using microneedle sensor arrays. Biosens Bioelectron. 2017 May 15;91:574-579. doi: 10.1016/j.bios.2017.01.016. Epub 2017 Jan 10.

    PubMed 28088750
  • Webster GD, Gabler HC. Feasibility of transdermal ethanol sensing for the detection of intoxicated drivers. Annu Proc Assoc Adv Automot Med. 2007;51:449-64.

    PubMed 18184507
  • Luczak SE, Rosen IG. Estimating BrAC from transdermal alcohol concentration data using the BrAC estimator software program. Alcohol Clin Exp Res. 2014 Aug;38(8):2243-52. doi: 10.1111/acer.12478.

    PubMed 25156615
  • Wang Y, Fridberg DJ, Leeman RF, Cook RL, Porges EC. Wrist-worn alcohol biosensors: Strengths, limitations, and future directions. Alcohol. 2019 Dec;81:83-92. doi: 10.1016/j.alcohol.2018.08.013. Epub 2018 Sep 1.

    PubMed 30179709
  • Fairbairn CE, Kang D. Temporal Dynamics of Transdermal Alcohol Concentration Measured via New-Generation Wrist-Worn Biosensor. Alcohol Clin Exp Res. 2019 Oct;43(10):2060-2069. doi: 10.1111/acer.14172. Epub 2019 Aug 30.

    PubMed 31469451
  • Hill-Kapturczak N, Roache JD, Liang Y, Karns TE, Cates SE, Dougherty DM. Accounting for sex-related differences in the estimation of breath alcohol concentrations using transdermal alcohol monitoring. Psychopharmacology (Berl). 2015 Jan;232(1):115-23. doi: 10.1007/s00213-014-3644-9. Epub 2014 Jun 13.

    PubMed 24923985
  • Fairbairn CE, Bresin K, Kang D, Rosen IG, Ariss T, Luczak SE, Barnett NP, Eckland NS. A multimodal investigation of contextual effects on alcohol's emotional rewards. J Abnorm Psychol. 2018 May;127(4):359-373. doi: 10.1037/abn0000346.

    PubMed 29745701
  • Dougherty DM, Charles NE, Acheson A, John S, Furr RM, Hill-Kapturczak N. Comparing the detection of transdermal and breath alcohol concentrations during periods of alcohol consumption ranging from moderate drinking to binge drinking. Exp Clin Psychopharmacol. 2012 Oct;20(5):373-81. doi: 10.1037/a0029021. Epub 2012 Jun 18.

    PubMed 22708608
  • Hill-Kapturczak N, Lake SL, Roache JD, Cates SE, Liang Y, Dougherty DM. Do variable rates of alcohol drinking alter the ability to use transdermal alcohol monitors to estimate peak breath alcohol and total number of drinks? Alcohol Clin Exp Res. 2014 Oct;38(10):2517-22. doi: 10.1111/acer.12528. Epub 2014 Oct 21.

    PubMed 25335857
  • Rash CJ, Petry NM, Alessi SM, Barnett NP. Monitoring alcohol use in heavy drinking soup kitchen attendees. Alcohol. 2019 Dec;81:139-147. doi: 10.1016/j.alcohol.2018.10.001. Epub 2018 Oct 8.

    PubMed 30308286

Questions about this trial

What is this clinical trial studying?

An observational study of Alcohol Drinking and Alcohol Intoxication, run by University of Illinois at Urbana-Champaign at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catharine Fairbairn, PhD (217-300-5850, uiucalcohollab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transdermal estimates of alcohol consumption (time frame: Across the 14 day period of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692830, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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