Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration

Assistance Publique Hopitaux De Marseille6 enrolled

Overview

A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration. One of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods. The purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

The Sweat Alcohol Concentration

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female 18-40 years, age-matched (+ 3 years) * Caucasian * BMI: 19 to 28 kg/m2 * No smoking or light smoker (\<5 cig/d) * Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience Exclusion Criteria: * Subjects with addiction to toxic or alcohol (MINI Questionnaire) * Positive individuals in search of drugs and toxic * Anxiety or depressive subjects (IASTA Questionnaires and BDI)

Outcomes

Primary Outcomes

The determination of ethanol in the plasma

blood samples

Time frame: 6 months

Secondary Outcomes

measures in the exhaled air

Assessed with the device Alcotest®

Time frame: 6 months

sweat alcohol concentration

assessed with a Transdermal monitor

Time frame: 6 months