Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations

Nanotechnology has the potential to become a powerful tool in addiction medicine. The
potential utility for passive, non-invasive wearable alcohol monitors is great and could play
a major role in public safety as well as in both research, clinical, and treatment settings.
Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and
imperceptibly samples interstitial fluid from the skin surface and measures relevant
biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial
fluid from just underneath the skin and then uses an electrochemical reaction to measure
either glucose or alcohol concentration. The participants' interstitial alcohol concentration
(IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that
a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the
participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and
the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood
alcohol concentrations. The LabPatch operational circuit lies on the underside of the
bandage. The circuit surface is placed in contact with the skin by the application of the
elastic adhesive bandage with a contact tension that provides modest pressure, as in the case
of a conventional wound bandage. The temperature of the skin is measured electrically and the
consistency of temperature is used to verify good contact and to monitor continued contact.
The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3
additional seconds to conduct the analysis.

Inclusion Criteria:

- Subject is capable of understanding and complying with the protocol

- Good physical and mental health (normal physical exam, ECG, blood and urine
chemistries, including absences of history or laboratory evidence of diabetes)

- Body Mass Index between 18-30, inclusive

- Age 21-50 years (age will be verified by driver's license or other valid form of
identification)

- Have used alcohol, on average, between 5-15 drinks per week over the past 6 months.

- Have a stable living situation with current postal address

Exclusion Criteria:

- Meets criteria for current alcohol or substance use disorders (Past alcohol or
substance use disorders greater than 3 years ago is acceptable)

- Concurrent diagnosis of Axis I disorder

- bMaintained on an antipsychotic or antidepressant medication; taking prescription
medications except certain short-term anti-fungal agents and some tropical creams for
dermal conditions

- Heavy alcohol drinkers (greater than 15 drinks per week)

- Tobacco use greater than 5 cigarettes per day

- History of major head trauma resulting in cognitive impairment or history of seizure
disorder

- Heavy caffeine use (greater than 500 mg on a regular daily basis)

- Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine
aminotransferase (ALT) > 3x the upper limit of normal

- For female volunteers, a positive pregnancy test