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

Not Applicable

Completed

• Conditions: The Sweat Alcohol Concentration
• Interventions: Other: oral dose of alcohol; Device: alcotest; Biological: blood samples; Device: Transdermal monitor

• Registration Number: NCT02860195
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-09
• Study Start: 2016-09
• Primary Completion: 2017-03
• Status Verified: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy volunteers	oral dose of alcohol	-
healthy volunteers	blood samples	-
healthy volunteers	Transdermal monitor	-
healthy volunteers	alcotest	-

Primary Outcome Measures

Name	Time	Method
The determination of ethanol in the plasma	6 months	blood samples

Secondary Outcome Measures

Name	Time	Method
measures in the exhaled air	6 months	Assessed with the device Alcotest®
sweat alcohol concentration	6 months	assessed with a Transdermal monitor