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

September 28, 2017 updated by: Assistance Publique Hopitaux De Marseille

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The determination of ethanol in the plasma
Time Frame: 6 months
blood samples
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measures in the exhaled air
Time Frame: 6 months
Assessed with the device Alcotest®
6 months
sweat alcohol concentration
Time Frame: 6 months
assessed with a Transdermal monitor
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: OLIVIER BLIN, ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-12
  • 2016-A00729-42 (Registry Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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