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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02860195
Acronym
ALCOOCAPT
Enrollment
6
Registered
2016-08-09
Start date
2016-09-30
Completion date
2017-09-30
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Sweat Alcohol Concentration

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.

Interventions

OTHERoral dose of alcohol
DEVICEalcotest
BIOLOGICALblood samples
DEVICETransdermal monitor

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
The determination of ethanol in the plasma6 monthsblood samples

Secondary

MeasureTime frameDescription
measures in the exhaled air6 monthsAssessed with the device Alcotest®
sweat alcohol concentration6 monthsassessed with a Transdermal monitor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026