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

Launched by MCLEAN HOSPITAL · Aug 3, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new skin patch called LabPatch-alcohol, which is designed to detect alcohol levels in the body without needing a blood sample. The patch works by measuring alcohol in the fluid just below the skin and will be tested to see how well these readings match with traditional blood tests. The researchers hope this non-invasive method will provide a convenient way to monitor alcohol levels in real-time.

To participate, you should be between 21 and 50 years old, in good physical and mental health, and have a history of drinking alcohol moderately—about 5 to 15 drinks per week. The study is currently looking for volunteers of all genders who can understand and follow the study instructions. If you join, you can expect to wear the patch while your alcohol levels are monitored, and you’ll help researchers learn more about this innovative technology. It's important to note that certain medical conditions and medications may exclude you from participating, so a thorough health screening will be done.

Gender

ALL

Eligibility criteria

• 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