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

Description

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.

Conditions

Alcohol Intoxication

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Alcohol Intoxication
Intervention / Treatment

-

Contacts and Locations

Belmont

McLean Hospital, Belmont, Massachusetts, United States, 02478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mclean Hospital,

Scott E Lukas, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

2024-04-30