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

NCT05692830 | Recruiting

• 1 other identifier: AA028488-01A1
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Intoxication

Keywords

transdermal alcohol content; ambulatory; transdermal biosensor; machine learning algorithms; breath alcohol content

Outcome Measures

Primary Outcomes (3)

• Transdermal estimates of alcohol consumption

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

  Across the 14 day period of the study

• Transdermal estimates of drinking risk level

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

  Across the 14 day period of the study

• Transdermal estimates of blood alcohol concentration

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

  Across the 14 day period of the study

Interventions

Alcohol DRUG

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Regular healthy drinkers aged 21+

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Champaign, Illinois, 61820, United States

RECRUITING

Related Publications (27)

• Kornacki B, Szreterowa M, Jablonska-Budajowa U, Goryszewska-Maciochowa H. [Transciliary lensectomy]. Klin Oczna. 1983 Nov-Dec;85(11-12):421-3. No abstract available. Polish.

  PMID: 6668891 BACKGROUND

• Bragg DG. Radiologic manpower. Issues and controversies. Invest Radiol. 1987 Jun;22(6):515. doi: 10.1097/00004424-198706000-00015. No abstract available.

  PMID: 3623856 BACKGROUND

• Leemhuis MP, Blom PS, Koevoet A. [Beta-carotene loading test as a screening test for steatorrhea]. Ned Tijdschr Geneeskd. 1971 Sep 11;115(37):1527-30. No abstract available. Dutch.

  PMID: 5569301 BACKGROUND

• Haxby DG, Rodriguez GS, Zechnich AD, Schuff RA, Tanigawa JS. Manufacturers' distribution of drug samples to a family medicine clinic. Am J Health Syst Pharm. 1995 Mar 1;52(5):496-9. doi: 10.1093/ajhp/52.5.496.

  PMID: 7606553 BACKGROUND

• Graham-Pole J. Treating acute lymphoblastic leukaemia after relapse: bone marrow transplantation or not? Lancet. 1989 Dec 23-30;2(8678-8679):1517-8. doi: 10.1016/s0140-6736(89)92953-x. No abstract available.

  PMID: 2574782 BACKGROUND

• Murdaugh HV Jr, Robin ED, Millen JE, Drewry WF, Weiss E. Adaptations to diving in the harbor seal: cardiac output during diving. Am J Physiol. 1966 Jan;210(1):176-80. doi: 10.1152/ajplegacy.1966.210.1.176. No abstract available.

  PMID: 5323319 BACKGROUND

• Lange DE. [Use of antibiotics in periodontal problem cases for prevention of bacteremia and prophylaxis of bacterial endocarditis]. Quintessenz. 1988 Jun;39(6):1047-51. No abstract available. German.

  PMID: 3217504 BACKGROUND

• Griesbach WE, Chaikoff IL, Nichols CW Jr, Goldberg RC. Formation of adenomata in hypophyses of rats subjected to both subtotal thyroidectomy and administration of 131-I, and its prevention by feeding of desiccated thyroid. Cancer Res. 1965 Nov;25(10):1804-16. No abstract available.

  PMID: 4159387 BACKGROUND

• Vihma Y, Korppi-Tommola T, Parkkulainen KV. Pelviureteric obstruction in children: the effect of pyeloplasty on 99mTc-DTPA uptake and washout. Z Kinderchir. 1984 Dec;39(6):358-63. doi: 10.1055/s-2008-1044245.

  PMID: 6395541 BACKGROUND

• Martelli MF, Falini B, Tabilio A, Aversa F. Topographical localization of intracellular immunoglobulins in hairy cells by immunoelectron microscopy. Acta Haematol. 1980;64(5):251-5. doi: 10.1159/000207277.

  PMID: 6779481 BACKGROUND

• Van Iddekinge B. Ectopic pregnancy: a review. S Afr Med J. 1972 Nov 25;46(47):1844-9. No abstract available.

  PMID: 4265311 BACKGROUND

• Molthan L, Crawford MN. Three examples of anti-Lub and related data. Transfusion. 1966 Nov-Dec;6(6):584-9. doi: 10.1111/j.1537-2995.1966.tb04782.x. No abstract available.

  PMID: 5951618 BACKGROUND

• Kopysc Z, Barczyk K, Krol E. [A new syndrome in the group of euhydrotic ectodermal dysplasias]. Pediatr Pol. 1986 Dec;61(12):790-7. No abstract available. Polish.

  PMID: 3601483 BACKGROUND

• Aitio A. Effect of chrysene and carbon tetrachloride administration on rat hepatic microsomal monooxygenase and UDPglucuronosyltransferase activity. FEBS Lett. 1974 May 15;42(1):46-9. doi: 10.1016/0014-5793(74)80275-9. No abstract available.

  PMID: 4211953 BACKGROUND

• Schmidt W, Merz WE, Lenhard V, Kubli F. Effects of crude and purified human chorionic gonadotropin on lymphocyte response. Gynecol Obstet Invest. 1981;12(3):132-40. doi: 10.1159/000299595.

  PMID: 6453759 BACKGROUND

• Hall R, Ramaiah RS, Jones DT. General practitioner hospitals: coming or going? Br Med J (Clin Res Ed). 1984 Jun 2;288(6431):1691. doi: 10.1136/bmj.288.6431.1691-a. No abstract available.

  PMID: 6426692 BACKGROUND

• Burke PM, Jancar J. Sensory and motor defect in severe mental subnormality. Ir J Med Sci. 1969 Oct;8(10):463-8. doi: 10.1007/BF02958617. No abstract available.

  PMID: 5364076 BACKGROUND

• Clarke ED, Goulding KH, Wardman P. Nitroimidazoles as anaerobic electron acceptors for xanthine oxidase. Biochem Pharmacol. 1982 Oct 15;31(20):3237-42. doi: 10.1016/0006-2952(82)90556-1.

  PMID: 6897358 BACKGROUND

• Heidrich HG, Strych W, Prehm P. Spontaneously released Plasmodium falciparum merozoites from culture possess glycoproteins. Z Parasitenkd. 1984;70(6):747-51. doi: 10.1007/BF00927127.

  PMID: 6395533 BACKGROUND

• Miller TR. 100 cases of hemipelvectomy: a personal experience. Surg Clin North Am. 1974 Aug;54(4):905-13. doi: 10.1016/s0039-6109(16)40396-8. No abstract available.

  PMID: 4428322 BACKGROUND

• Ladwa RA. Comparison of Syndol and paracetamol in the relief of dental pain. Br Dent J. 1981 Apr 7;150(7):187-8. doi: 10.1038/sj.bdj.4804571. No abstract available.

  PMID: 6938217 BACKGROUND

• Hoskins IA, Hemming VG, Johnson TR, Winkel CA. Effects of alterations of zinc-to-phosphorus ratios and meconium content on group B Streptococcus growth in human amniotic fluid in vitro. Am J Obstet Gynecol. 1987 Sep;157(3):770-3. doi: 10.1016/s0002-9378(87)80047-9.

  PMID: 3307431 BACKGROUND

• Kirsch WM, Stears JC. Radiographic identification and surgical excision of an epidermoid tumor of the pineal gland. Case report. J Neurosurg. 1970 Dec;33(6):708-13. doi: 10.3171/jns.1970.33.6.0708. No abstract available.

  PMID: 5312639 BACKGROUND

• Agrawal HC, Fishman MA, Prensky AL. A possible block in the intermediary metabolism of glucose into proteins and lipids in the brains of undernourished rats. Lipids. 1971 Jun;6(6):431-3. doi: 10.1007/BF02531382. No abstract available.

  PMID: 4330106 BACKGROUND

• Kanerud L, Hafstrom I. [Acute arthritis and subcutaneous fat necrosis as the first symptom of pancreatic cancer]. Lakartidningen. 1986 Feb 19;83(8):609-10. No abstract available. Swedish.

  PMID: 3951286 BACKGROUND

• Ritter D. The need for risk assessment legislation. Risk Anal. 1988 Jun;8(2):169-70. doi: 10.1111/j.1539-6924.1988.tb01166.x. No abstract available.

  PMID: 3413308 BACKGROUND

• Shah GN, Li J, Schneiderjohn P, Mooradian AD. Cloning and characterization of a complementary DNA for a thyroid hormone-responsive protein in mature rat cerebral tissue. Biochem J. 1997 Oct 15;327 ( Pt 2)(Pt 2):617-23. doi: 10.1042/bj3270617.

  PMID: 9359437 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking; Alcoholic Intoxication

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Catharine Fairbairn, PhD

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharine Fairbairn, PhD

CONTACT

217-300-5850; uiucalcohollab@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: January 20, 2023
• Study Start: October 22, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)