Alcohol AbusePETHOXICONCT04557631
Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
An observational study of Alcohol Abuse, run by University Hospital, Lille.
Trial summary
For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to: to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study will be proposed to all major ethanol-consuming patients with an alcohol use disorder, seen in consultation, in anticipation of hospital withdrawal in addiction service.
Who may be able to join
- Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria
- Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.
Who cannot join
- Patient opposing the use of their personal data in the study
- Patient subject to protective measures (guardianship or curatorship)
- Person deprived of liberty
About this study
For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:
- to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.
- Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)
- Conditions
- Alcohol Abuse
- Medical subject headings
- Alcoholism
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with a Peth concentration greater than 200 µg/L
Measured: at the end of study (at 6 months)
Secondary outcomes (3)
the concentration of Peth in blood in ambiant temperature
descrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and stored at room temperature,
Measured: between T0 and 96h and the end of study (at 6 months)
the concentration of Peth in blood at 4°C
ecrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and at 4°C.
Measured: between T0 and 96h and the end of study (at 6 months)
the concentration of Peth in blood in DBS
decrease expressed as a percentage of the initial concentration, in the Dried Blood Spot (DBS)
Measured: between T0 and 4 weeks and the end of study (at 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Sep 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Why it stopped: sponsor décision COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557631
- Sponsor's protocol ID
- 2019_02
- Other IDs
- 2019-A02683-54
- Acronym
- PETHOXICO
- Status last verified
- May 2026
- First submitted
- 15 Sep 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
- ClinicalTrials.gov ID
- NCT04557631
- Acronym / sponsor ID
- PETHOXICO / 2019_02
- Conditions
- Alcohol Abuse
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sponsor décision COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- 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.
For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:
- to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.
- Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study will be proposed to all major ethanol-consuming patients with an alcohol use disorder, seen in consultation, in anticipation of hospital withdrawal in addiction service.
Key inclusion criteria (2 listed)
- Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria
- Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.
Key exclusion criteria (3 listed)
- Patient opposing the use of their personal data in the study
- Patient subject to protective measures (guardianship or curatorship)
- Person deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of patients with a Peth concentration greater than 200 µg/L
Time frame: at the end of study (at 6 months)
3 secondary outcomes
the concentration of Peth in blood in ambiant temperature
Time frame: between T0 and 96h and the end of study (at 6 months)
the concentration of Peth in blood at 4°C
Time frame: between T0 and 96h and the end of study (at 6 months)
the concentration of Peth in blood in DBS
Time frame: between T0 and 4 weeks and the end of study (at 6 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Olivier COTTENCIN, MD,PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Abuse, run by University Hospital, Lille.
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 2 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: withdrawn, as of the sponsor's last update on 22 May 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of patients with a Peth concentration greater than 200 µg/L (time frame: at the end of study (at 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 22 May 2026.