LabPatch-alcohol for Alcohol Intoxication

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Overseen ByScott Lukas, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable patch called LabPatch-alcohol, designed to detect alcohol levels through the skin without a blood test. The study compares the patch's readings to traditional blood alcohol tests to assess accuracy. Individuals who have consumed 5-15 drinks per week for the past 6 months and are in good health may qualify. Participants will wear the patch after consuming alcohol to monitor its performance. As an Early Phase 1 trial, this research aims to understand how the patch functions in people, offering participants the opportunity to experience this innovative technology firsthand.

What prior data suggests that this device is safe for detecting alcohol levels?

Research has shown that wearable alcohol monitors, such as the LabPatch-alcohol, are generally easy to use and do not cause harm. Studies have found that these devices can safely track alcohol levels through the skin. For instance, one study successfully used alcohol monitors for extended periods, indicating their safety for long-term use. Although this specific patch is still under testing, it relies on technology already used for skin alcohol monitoring. This suggests it is likely safe, as similar devices have not reported major problems.12345

Why are researchers excited about this trial?

LabPatch-alcohol is unique because it offers a noninvasive way to monitor blood alcohol concentrations through a skin patch. Unlike traditional methods that require blood tests or breathalyzers, this patch uses a sensor to detect alcohol levels without needing a needle or a breath sample. Researchers are excited about this innovation because it could provide continuous monitoring in a more comfortable and convenient way, offering real-time data without the discomfort or inconvenience of current methods.

What evidence suggests that this LabPatch-alcohol is effective for detecting alcohol concentrations?

Studies have shown that devices like the LabPatch-alcohol, worn on the skin, effectively track alcohol levels. These sensors often align closely with breath test results, detecting alcohol use in about 70% of cases within 30 minutes after drinking. Research indicates that people find these wearable sensors easy to use and are willing to use them. Although this trial is still testing the LabPatch-alcohol, the technology shows promise for accurately measuring alcohol levels without a breathalyzer, offering a convenient alternative to traditional methods.26789

Who Is on the Research Team?

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Scott E Lukas, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-50 with a BMI of 18-30, who drink alcohol moderately (5-15 drinks per week). Participants must understand the study and be in good physical and mental health without diabetes. They need a stable living situation and will have to provide ID proof.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 30.
You have been drinking an average of 5 to 15 drinks per week for the past 6 months.
You have a stable place to live with a current address.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are administered alcohol and monitored using the LabPatch-alcohol sensor to measure interstitial alcohol concentrations

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • LabPatch-alcohol

Trial Overview

The LabPatch-alcohol, a wearable skin patch, is being tested for its ability to monitor alcohol levels non-invasively by comparing its readings with blood alcohol concentrations to check if it's as reliable as standard tests.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LabPatch-alcoholExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

Citations

Accuracy of Wearable Transdermal Alcohol Sensors - PMC

The results for transdermal alcohol concentration data from various transdermal alcohol sensors were generally found to positively correlate with breath ...

Exploring the accuracy of transdermal drinking detection

Regarding the time course of drinking detection, sensors identified most (70 %) cases of alcohol consumption for data points within 30 minutes ...

Acceptability and Feasibility of Wearable Transdermal Alcohol ...

The primary outcome was TAS acceptability. The secondary outcome was feasibility. Although views on TASs were generally positive with high ...

Development of LabPatch-alcohol as a Noninvasive Skin ...

This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time ...

feasibility and acceptability in a pilot study

All participants were able to successfully use the alcohol monitors, producing a total of 24 out of 25 possible days of alcohol monitoring data.

Development of LabPatch-alcohol as a Noninvasive Skin ...

This study is designed to test LabPatch-alcohol, is designed to detect real-time changes in interstitial alcohol concentrations

Using Transdermal Alcohol Monitoring to Detect Low-Level ...

Several studies demonstrate the utility of Alcohol Monitoring System's (AMS) transdermal alcohol concentration (TAC) monitor to objectively quantify drinking.

Sensing Safety: Developing a Flexible, Portable Alcohol ...

The patch's ability to monitor alcohol consumption discreetly will have wide applications, from public health and addiction recovery to transportation safety.

Alcohol Sensor - App Store - Apple

A comprehensive solution for managing alcohol breath tests and ensuring workplace safety. With over 5 million breath alcohol tests performed worldwide.