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

Running, not enrolling · Early Phase 1

Conditions studied: Alcohol Intoxication

In brief

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.

Key facts

Study ID

NCT03242161

Run by

Mclean Hospital

People needed

8

Starts

2018-01-01

Expected to finish

2026-12-11

Last updated by the study team

2026-07-14

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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