Alcohol consumption has universal prevalence and widespread socio-cultural reach. The addictive nature of alcohol has resulted in the compulsive and uncontrolled consumption of alcoholic beverages for a sizeable segment of the global population. Overconsumption of alcohol is associated with a plethora of physiological and mental health consequences, some of which include alcohol dependence, liver cirrhosis, cancers, and bodily injury from operating machinery while intoxicated [1]. Not surprisingly, alcohol misuse is the fifth leading risk factor for premature death and disability, however, astonishingly, among people between the ages of 15 and 49, it is the first [2]. In the United States alone, alcohol misuse resulted in nearly 88,000 fatalities in 2006 [3] and was responsible for an economic burden of over $200 billion [4]. A recent study reported in 2012 concluded that 7.2 percent of the adult population in the US was affected by an alcohol use disorder (AUD) [5], further substantiating the widespread prevalence of this disease. In spite of these statistics, most of the human and economic tolls of alcoholism are preventable through various programs aimed at identifying the instigators of overconsumption [3]. This project aims to address the above challenges associated with the management of AUD via the development of an alcohol-selective microneedle array biosensor, applied to the skin as a concealed transdermal patch. The proposed wearable device leverages our team's latest innovations in electrochemistry, micro-manufacturing, conducting polymers, surface functionalization, and wireless microelectronics to tender the real-time profile of circulating alcohol levels in the interstitial luid in a non-invasive, pain-free fashion, thereby leading to substantially improved compliance over existing alcohol monitoring solutions. Expected outcomes from this research project include: (1) the development of unobtrusive, low-cost microneedle-based biosensors containing an embedded alcohol-selective layer; (2) the pairing of said alcohol biosensors with an onboard electrochemical analyzer and low-power wireless transmission capabilities facilitating the presentation of results to the operator and archiving for compliance purposes; and (3) validation of the microneedle-based alcohol quantification method in the clinical setting. This approach agglomerates innovative techniques for the functionalization of the microneedle-based electrode contingent and relies on the development of biocatalytic transducers in connection with novel methods of electrochemical transduction. The salient features of this transdermal biosensor platform include high sensitivity, stability, selectivity, simplicity, versatility, and robustness t a price that is amenable to widespread adoption. By evaluating the platform in the clinical setting, the insight gathered from this study could lead towards the development of a wearable platform capable of identifying the instigators of overconsumption, monitoring trends, and assessing compliance with prescribed treatment regimens, hence ensuring improved outcomes and management of the disease.

Public Health Relevance

The proposed project aims to demonstrate the capability to quantify blood alcohol levels in real time via the development of a microneedle array biosensor, applied as a non-invasive transdermal patch. This new wearable biosensor paradigm will impart the ability to precisely track circulating alcohol levels in the interstitial fluid in an autonomou, unobtrusive, and immediate fashion and is especially suited for those who are affected by alcohol use disorder (AUD) and desire a concealed method for assessing compliance while avoiding the social stigmas associated with managing the disease. The proposed research will substantially advance the state-of-the-art in the AUD domain and will circumvent many of the limitations associated with conventional 'snapshot' methods of alcohol assessment such as breath analysis and venipuncture.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44AA024643-01
Application #
9049223
Study Section
Special Emphasis Panel (ZAA1-JJ (01))
Program Officer
Dunty, Jr, William
Project Start
2015-09-10
Project End
2016-08-31
Budget Start
2015-09-10
Budget End
2016-08-31
Support Year
1
Fiscal Year
2015
Total Cost
$181,913
Indirect Cost
Name
Electrozyme, LLC
Department
Type
DUNS #
078535881
City
Encinitas
State
CA
Country
United States
Zip Code
92024
Mohan, A M Vinu; Windmiller, Joshua Ray; Mishra, Rupesh K et al. (2017) Continuous minimally-invasive alcohol monitoring using microneedle sensor arrays. Biosens Bioelectron 91:574-579