Understanding blood markers for alcohol consumption
Phosphatidylethanol and Other Ethanol Consumption Markers
This study is testing if a blood marker called PEth can help us understand how much and how often people drink alcohol by looking at their blood after they consume alcohol in a lab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 2 sites (Denton, Texas and 1 other locations) |
| Trial ID | NCT06747364 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how a specific biomarker in the blood, Phosphatidylethanol (PEth), can be used to identify different patterns and quantities of alcohol consumption. Participants will consume alcohol in a controlled lab setting to achieve a target blood alcohol concentration, followed by blood sample collections over a period of time to analyze PEth levels and other biological variables. The study combines in vivo and ex vivo methodologies to improve the understanding of individual differences in alcohol metabolism and its implications for future alcohol prevention and treatment programs.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 21 and older who consume alcohol on multiple days and can achieve a specific blood alcohol concentration.
Not a fit: Patients with significant alcohol withdrawal symptoms, those currently in alcohol treatment, or individuals with certain medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of alcohol consumption assessments, leading to better prevention and treatment strategies for alcohol-related issues.
How similar studies have performed: Other studies have explored biomarkers for alcohol consumption, but this specific approach combining controlled consumption and biological variable analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. are ≥ 21 years old; 2. are height and weight proportionate (body mass index 18-30); and 3. report drinking on \> 1 days in the last month, with at least one day equal to at least achieving \~0.06% BAC. Exclusion Criteria: 1. have significant current or predicted alcohol withdrawal symptoms (CIWA-AR scores ≥ 10); 2. are currently in alcohol treatment; 3. have substance use disorder (except nicotine, and/or caffeine); 4. have a medical condition that would contraindicate participation (a positive urine pregnancy test, self-reported scheduled surgery or liver disease); 5. are currently breast feeding; 6. have a presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium; or 7. are unable to comprehend the informed consent process or study instructions.
Where this trial is running
Denton, Texas and 1 other locations
- University of North Texas — Denton, Texas, United States (Recruiting)
- University of Texas Health Science Center San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nathalie Hill-Kapturczak, PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Nathalie Hill-Kapturczak, PhD
- Email: Hillkapturcz@uthscsa.edu
- Phone: 210-567-2725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.