Wearable patch to detect blood alcohol levels noninvasively
Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid
This study is testing a new wearable patch that can measure alcohol levels in your body without needing a blood sample to see if it works well for monitoring drinking habits.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT03242161 on ClinicalTrials.gov |
What this trial studies
This study tests LabPatch-alcohol, a non-invasive biosensor patch designed to monitor real-time changes in interstitial alcohol concentrations in human subjects. The patch utilizes nanotechnology to sample interstitial fluid from the skin and measure alcohol levels through an electrochemical reaction. Participants will wear the patch while their blood alcohol concentrations are also measured, allowing for a direct comparison to validate the patch's effectiveness. The goal is to establish the patch as a reliable tool for monitoring alcohol levels, which could enhance public safety and treatment options in addiction medicine.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21-50 who consume alcohol moderately, averaging 5-15 drinks per week.
Not a fit: Patients with current alcohol or substance use disorders or those consuming more than 15 drinks per week may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide a convenient and non-invasive method for monitoring alcohol consumption, aiding in both clinical and public safety applications.
How similar studies have performed: While the use of wearable biosensors is a growing field, this specific application for alcohol monitoring is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Scott E Lukas, PhD — Mclean Hospital
- Study coordinator: Scott Lukas, PhD
- Email: slukas@mclean.harvard.edu
- Phone: 617-855-2767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.