Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

Alcohol Abuse Clinical Trial

— PETHOXICO  

Official title:

Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04557631
• Other study ID #: 2019_02
• Secondary ID: 2019-A02683-54
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Lille
• Contact: Olivier COTTENCIN, MD,PhD
• Phone: 0320445962
• Email: olivier.cottencin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

• 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient opposing the use of their personal data in the study

• Patient subject to protective measures (guardianship or curatorship)

• Person deprived of liberty

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients with a Peth concentration greater than 200 µg/L		at the end of study (at 6 months)
Secondary	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,	between T0 and 96h and the end of study (at 6 months)
Secondary	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.	between T0 and 96h and the end of study (at 6 months)
Secondary	the concentration of Peth in blood in DBS	decrease expressed as a percentage of the initial concentration, in the Dried Blood Spot (DBS)	between T0 and 4 weeks and the end of study (at 6 months)