Kathy Jung, Division of Metabolism and Health Effects

Purpose

The purpose of this announcement is to renew the National Institute on Alcohol Abuse and Alcoholism’s initiative on the development of a wearable alcohol biosensor. Currently, assessment of alcohol consumption relies primarily on inherently subjective self-report through surveys ranging from AUDIT, AUDIT -C, to Timeline Follow Back and other more extensive survey instruments.  A precise, accurate and objective means of assessing alcohol exposure will facilitate many aspects of the NIAAA mission. 

It is necessary to reach beyond the alcohol research community to enlist entrepreneurs and engineers with the skills needed to design and produce an alcohol-sensing device.  NIAAA proposes to use all mechanisms permitted by NIH legal authority to solicit and support the development and commercialization of a wearable alcohol biosensor.

Background

Self-report of alcohol consumption is notoriously unreliable.  In many setting and applications, a precise and accurate measure of alcohol consumption, and more directly, of blood alcohol concentration (BAC) across time, would be extremely informative to research, to treatment, and to clinical trial management. Devices that detect alcohol in sweat and sweat vapor have existed for more than three decades. These provide a signal reporting the presence of alcohol in the system but are unable to provide quantitative data. Alcohol Monitoring Systems successfully markets the SCRAM device for criminal justice applications and Giner’s WrisTAS has been used in early research settings. These and other early devices tend to be cumbersome.

Alcohol-detecting breathalyzers available to consumers allow individuals to track their alcohol drinking and are used in some treatment and research settings. However, breathalyzers require action and willingness on the part of the wearer and provide only snapshots in time, not a continuous record.

In 2015, NIAAA introduced an initiative to encourage the development of a Wearable Alcohol Biosensor. The goal, to obtain a record of BAC in real time, in a less cumbersome, non-stigmatizing wearable, has been elusive.  Since 2015, NIAAA has supported the research and development of wearable alcohol biosensors through small business grants and contracts and through challenge competitions.  To jumpstart the development of a wearable alcohol biosensor, NIAAA issued a challenge competition, a procedure new to the federal government in 2015. With a first prize of $200,000 and a second prize of $100,000, inventors were challenged to develop a prototype of a wearable device that measures and reports BAC in real time, unprompted by the wearer or other source.

The 2015-2016 challenge winners were BACtrack, with its Skyn prototype, and Milo. While significant advances in sampling interval, wearer acceptance, and other features were achieved, the alcohol sensing technology, still based on sweat alcohol content, retains drawbacks. NIAAA issued a second challenge in late 2016, awarding a single prize of $100,000 to Quantac.  BACtrack has continued to improve the Skyn wrist device and now makes it available to alcohol researchers for a fee, while advancing validation.  While Milo is also working to optimize their device, neither alcohol monitor is on the open market.  Inroads into more precise technologies area available for non-wearable alcohol-detection devices intended for employee screening in the workplace.  Near infrared technology that accurately quantifies interstitial alcohol content may be a viable approach if it can be miniaturized to wearable scale.

In addition to the challenge competitions mentioned, twenty SBIR or STTR grants across a variety of technological approaches have been awarded since 2015.  A further four SBIR contracts with expanded budgets have been or are being supported.

Scope/Objectives

The ideal wearable alcohol biosensor will

• Detect and record BAC in real time and provide meaningful output
• Collect and interpret data, eliminating as much of the biological and device-related delays as possible
• Store or transmit data to a smartphone or other device by wireless transmission.
• Provide data storage and transmission that is completely secure, protecting the privacy of the individual
• Verify standardization at regular intervals and indicate loss of functionality
• Operate from a dependable and rechargeable power source

The form factor should be non-invasive or minimally invasive and should be acceptable and affordable for individual wearers. It is desirable that the technology permits subject identification.  The ability to correlate systemic alcohol exposure with its physiological effects will be of great value.  The characteristics of an ideal wearable alcohol biosensor include passive alcohol detection that is accurate, with real time measurements at intervals that provide complete information about the time to peak blood alcohol concentration, duration of elevated BAC, and rate of elimination or time to undetectable BAC. 

Justification/Outcome

NIAAA communicates its desire to continue the quest for a wearable alcohol biosensor and seeks the National Advisory Council’s comments and suggestions.  The availability of a functional, reliable wearable alcohol biosensor will advance NIAAA’s mission in multiple arenas.

• Treatment for alcohol use disorder
• Medications development
• Addiction research
• Research on adverse health effects of alcohol misuse, including alcohol-related organ damage
• Consumer education on individual consumption

Mechanisms

NIAAA proposes to use all mechanisms permitted by NIH legal authority to solicit and support the development and commercialization of a wearable alcohol biosensor.