The Sweat Alcohol ConcentrationALCOOCAPTNCT02860195
Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
A study testing oral dose of alcohol, alcotest and blood samples in people with The Sweat Alcohol Concentration, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- The Sweat Alcohol Concentration
- What is being tested?
- oral dose of alcohol, alcotest and blood samples
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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.
- Conditions
- The Sweat Alcohol Concentration
- Being tested
- oral dose of alcohol, alcotest, blood samples, Transdermal monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral dose of alcoholOther
alcotestDevice
blood samplesBiological
Transdermal monitorDevice
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Other: oral dose of alcohol; Device: alcotest; Biological: blood samples; Device: Transdermal monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The determination of ethanol in the plasma
blood samples
Measured: 6 months
Secondary outcomes (2)
measures in the exhaled air
Assessed with the device Alcotest®
Measured: 6 months
sweat alcohol concentration
assessed with a Transdermal monitor
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Sweat Alcohol ConcentrationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hopitaux De MarseilleOLIVIER BLIN, Principal investigator, ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860195
- Sponsor's protocol ID
- 2016-12
- Other IDs
- 2016-A00729-42
- Acronym
- ALCOOCAPT
- Status last verified
- Sep 2017
- First submitted
- 27 Jul 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
- ClinicalTrials.gov ID
- NCT02860195
- Acronym / sponsor ID
- ALCOOCAPT / 2016-12
- Conditions
- The Sweat Alcohol Concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: oral dose of alcohol, Device: alcotest, Biological: blood samples, Device: Transdermal monitor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral dose of alcohol | Other | healthy volunteers |
| alcotest | Device | healthy volunteers |
| blood samples | Biological | healthy volunteers |
| Transdermal monitor | Device | healthy volunteers |
Primary outcome
The determination of ethanol in the plasma
Time frame: 6 months
blood samples
2 secondary outcomes
measures in the exhaled air
Time frame: 6 months
sweat alcohol concentration
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
OLIVIER BLIN principal investigator
ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE
Questions about this trial
What is this clinical trial studying?
A study testing oral dose of alcohol, alcotest and blood samples in people with The Sweat Alcohol Concentration, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The determination of ethanol in the plasma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.