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

Alcohol Intoxication Clinical Trial

Official title:

Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242161
• Other study ID #: 2017P001502
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Mclean Hospital
• Contact: Scott Lukas, PhD
• Phone: 617-855-2767
• Email: slukas[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Intoxication
• Alcoholic Intoxication

Intervention

Diagnostic Test:
• LabPatch-alcohol
a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial and Blood Alcohol Concentrations	Interstitial (from the skin surface) alcohol concentrations will be obtained via the LabPatch band-aid while at the same time blood samples will be collected in an attempt to correlate the two. The LabPatch-alcohol is a completely noninvasive device and the goal is to determine is precision against the gold standard--blood alcohol concentrations.	Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.