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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860195
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: healthy volunteers Other: oral dose of alcohol
Device: alcotest
Biological: blood samples
Device: Transdermal monitor



Primary Outcome Measures :
  1. The determination of ethanol in the plasma [ Time Frame: 6 months ]
    blood samples


Secondary Outcome Measures :
  1. measures in the exhaled air [ Time Frame: 6 months ]
    Assessed with the device Alcotest®

  2. sweat alcohol concentration [ Time Frame: 6 months ]
    assessed with a Transdermal monitor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Catherine GEINDRE Assistance Publique Hopitaux De Marseille
Principal Investigator: OLIVIER BLIN ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02860195    
Other Study ID Numbers: 2016-12
2016-A00729-42 ( Registry Identifier: ANSM )
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases