Status:
RECRUITING
Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations
Lead Sponsor:
Mclean Hospital
Conditions:
Alcohol Intoxication
Eligibility:
All Genders
21-50 years
Phase:
EARLY_PHASE1
Brief 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 sub...
Detailed 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 publ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03242161
Start Date
January 1 2018
End Date
April 30 2024
Last Update
January 5 2024
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478