Evaluation of the Sensitivity of a Transdermal Device to... | NCT02860195

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

NCT02860195

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

The Sweat Alcohol Concentration

Interventions

oral dose of alcohol
alcotest
blood samples
Transdermal monitor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-A00729-42	Registry Identifier	ANSM

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Jul 27, 2016

First Submission Date that Met QC Criteria

Aug 5, 2016

First Posted Date

Aug 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2017

Last Update Posted Date

Oct 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy volunteers	Experimental		Other: oral dose of alcohol Device: alcotest Biological: blood samples Device: Transdermal monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral dose of alcohol	Other		healthy volunteers
alcotest

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine GEINDRE	Assistance Publique Hopitaux De Marseille	Study Director
OLIVIER BLIN	ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000431	Ethanol
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided