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LabPatch-alcohol for Alcohol Intoxication

Phase < 1
Recruiting
Led By Scott E Lukas, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-50 years (age will be verified by driver's license or other valid form of identification)
Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absences of history or laboratory evidence of diabetes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.
Awards & highlights

Study Summary

This trial will test a wearable patch that detects changes in alcohol levels to see if it is accurate compared to the gold standard method.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the LabPatch-alcohol is noninvasive and functions like a Band-Aid, side effects are expected to be minimal but may include skin irritation or allergic reactions at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 50 years old.
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I am in good physical and mental health, with no diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.
This trial's timeline: 3 weeks for screening, Varies for treatment, and both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interstitial and Blood Alcohol Concentrations

Trial Design

1Treatment groups
Experimental Treatment
Group I: LabPatch-alcoholExperimental Treatment1 Intervention
All subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,686 Total Patients Enrolled
Scott E Lukas, PhDPrincipal InvestigatorMclean Hospital
2 Previous Clinical Trials
56 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations
Scott Lukas 2018. "Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03242161.
~0 spots leftby Apr 2024
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