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

Primary Purpose

The Sweat Alcohol Concentration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral dose of alcohol
alcotest
blood samples
Transdermal monitor
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for The Sweat Alcohol Concentration

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    healthy volunteers

    Arm Description

    Outcomes

    Primary Outcome Measures

    The determination of ethanol in the plasma
    blood samples

    Secondary Outcome Measures

    measures in the exhaled air
    Assessed with the device Alcotest®
    sweat alcohol concentration
    assessed with a Transdermal monitor

    Full Information

    First Posted
    July 27, 2016
    Last Updated
    September 28, 2017
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02860195
    Brief Title
    Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
    Acronym
    ALCOOCAPT
    Official Title
    Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    The Sweat Alcohol Concentration

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    healthy volunteers
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    oral dose of alcohol
    Intervention Type
    Device
    Intervention Name(s)
    alcotest
    Intervention Type
    Biological
    Intervention Name(s)
    blood samples
    Intervention Type
    Device
    Intervention Name(s)
    Transdermal monitor
    Primary Outcome Measure Information:
    Title
    The determination of ethanol in the plasma
    Description
    blood samples
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    measures in the exhaled air
    Description
    Assessed with the device Alcotest®
    Time Frame
    6 months
    Title
    sweat alcohol concentration
    Description
    assessed with a Transdermal monitor
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine GEINDRE
    Organizational Affiliation
    Assistance Publique Hopitaux De Marseille
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    OLIVIER BLIN
    Organizational Affiliation
    ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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