What side effects are associated with this type of intervention?

Common treatments for alcohol intoxication include supportive care, administration of intravenous fluids, and monitoring of vital signs. In severe cases, medications such as benzodiazepines may be used to manage withdrawal symptoms. Side effects of these treatments can include drowsiness, dizziness, and in some cases, respiratory depression. Non-invasive methods like the LabPatch-alcohol, which detect interstitial alcohol concentrations, are primarily diagnostic and do not have direct side effects related to treatment. However, the accuracy and reliability of such devices are still under investigation.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for alcohol intoxication mentioned in the provided context. The LabPatch-alcohol is a non-invasive biosensor designed to detect real-time changes in interstitial alcohol concentrations, which is a novel approach and not directly related to existing pharmacologic treatments. Broadly, treatments for alcohol use disorders include medications like naltrexone, acamprosate, and disulfiram, which are FDA-approved for managing alcohol dependence but not specifically for acute intoxication.

What other types of research exist?

Promising alternatives to LabPatch-alcohol for non-invasive detection of alcohol intoxication include: 1) Transdermal alcohol biosensors, which measure alcohol levels through the skin using advanced materials and electronics. 2) Breathalyzers with improved sensitivity and specificity, utilizing advanced sensor technologies and algorithms. 3) Saliva-based alcohol detection devices that offer rapid and accurate results through non-invasive sampling. These alternatives provide real-time monitoring, accuracy, and ease of use, making them suitable for managing alcohol intoxication in patients.

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LabPatch-alcohol for Alcohol Intoxication

Q: What is the mechanism of action of this treatment?

The most common treatments for alcohol intoxication include supportive care, administration of intravenous fluids, and monitoring of vital signs. Supportive care involves ensuring the patient's airway is clear, breathing is adequate, and circulation is stable. Intravenous fluids help to correct dehydration and electrolyte imbalances caused by excessive alcohol consumption. Monitoring vital signs is crucial to detect and manage complications such as respiratory depression or cardiac arrhythmias. These treatments are essential for stabilizing patients and preventing severe outcomes. Non-invasive detection methods like LabPatch-alcohol, which monitor interstitial alcohol concentrations, can provide real-time data to guide these interventions more effectively, ensuring timely and appropriate care.

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

No Placebo-Only Group

Summary

This trial tests a wearable patch called LabPatch-alcohol that measures alcohol levels through the skin. It targets people who drink alcohol to see if the patch is as accurate as blood tests. The patch uses tiny wires and a chemical reaction to check alcohol levels in skin fluid.

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.

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.

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

Select...

I am between 21 and 50 years old.

Select...

I am in good physical and mental health, with no diabetes.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interstitial and Blood Alcohol Concentrations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for alcohol intoxication include supportive care, administration of intravenous fluids, and monitoring of vital signs. Supportive care involves ensuring the patient's airway is clear, breathing is adequate, and circulation is stable. Intravenous fluids help to correct dehydration and electrolyte imbalances caused by excessive alcohol consumption. Monitoring vital signs is crucial to detect and manage complications such as respiratory depression or cardiac arrhythmias. These treatments are essential for stabilizing patients and preventing severe outcomes. Non-invasive detection methods like LabPatch-alcohol, which monitor interstitial alcohol concentrations, can provide real-time data to guide these interventions more effectively, ensuring timely and appropriate care.