Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration (ALCOOCAPT)
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|ClinicalTrials.gov Identifier: NCT02860195|
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : October 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|The Sweat Alcohol Concentration||Other: oral dose of alcohol Device: alcotest Biological: blood samples Device: Transdermal monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||September 2017|
|Experimental: healthy volunteers||
Other: oral dose of alcohol
Biological: blood samples
Device: Transdermal monitor
- The determination of ethanol in the plasma [ Time Frame: 6 months ]blood samples
- measures in the exhaled air [ Time Frame: 6 months ]Assessed with the device Alcotest®
- sweat alcohol concentration [ Time Frame: 6 months ]assessed with a Transdermal monitor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860195
|Study Director:||Catherine GEINDRE||Assistance Publique Hopitaux De Marseille|
|Principal Investigator:||OLIVIER BLIN||ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE|