ClinicalTrials.Veeva

Menu

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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

The Sweat Alcohol Concentration

Treatments

Device: Transdermal monitor
Biological: blood samples
Device: alcotest
Other: oral dose of alcohol

Study type

Interventional

Funder types

Other

Identifiers

NCT02860195
2016-12
2016-A00729-42 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

healthy volunteers
Experimental group
Treatment:
Device: Transdermal monitor
Other: oral dose of alcohol
Biological: blood samples
Device: alcotest

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems