Actively Recruiting
Phosphatidylethanol and Other Ethanol Consumption Markers to Study Alcohol Use Patterns
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-05-13
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how a blood biomarker called Phosphatidylethanol (PEth) can be used to better identify the amount and patterns of alcohol use. The study aims to understand individual differences in biological factors affecting PEth formation and improve how alcohol consumption is characterized through this marker. Results may help develop future alcohol prevention and treatment programs to benefit others. Participants will take part in three related experiments. First, up to 40 healthy volunteers will consume alcohol in a lab to reach a blood alcohol concentration of 0.06%, with blood samples collected over 6 hours. Then, they will abstain from alcohol for 10 days with blood collected 4 times. After this, participants will drink normally outside the lab for 28 days, providing weekly blood samples. A second group of 40 participants will join only the natural drinking part with weekly blood collections over 28 days. During the study, participants will provide blood samples at specific times to measure PEth levels, breath alcohol concentration, red blood cell count, and other biological variables. They will also report their alcohol use during the natural drinking phase. The main outcomes include changes in PEth concentrations and self-reported drinking patterns. The study includes safety monitoring and may last up to 28 days for naturalistic drinking plus additional days for lab visits.
CONDITIONS
Brief Title
Phosphatidylethanol and Other Ethanol Consumption Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 21 years old or older
- Have a body mass index (BMI) between 18 and 30
- Report drinking alcohol on more than 1 day in the last month, with at least one day reaching about 0.06% blood alcohol concentration
You will not qualify if you...
- Have significant current or predicted alcohol withdrawal symptoms (CIWA-AR scores 10 or higher)
- Are currently in alcohol treatment
- Have substance use disorder except for nicotine or caffeine
- Have medical conditions that prevent participation such as positive pregnancy test, planned surgery, or liver disease
- Are currently breastfeeding
- Have psychiatric disorders with symptoms of psychosis or delirium
- Are unable to understand the informed consent or study instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants consume alcohol in a controlled laboratory setting designed to reach a target blood alcohol concentration of 0.06%. Blood samples are collected repeatedly over a 6-hour period to measure alcohol and PEth levels.
1 in-person visit with multiple blood collections over 6 hours
Duration - 10 days
Participants abstain from alcohol for 10 days following alcohol consumption. Blood samples are collected during this period to characterize PEth elimination.
4 visits with 1 blood sample collected at each visit
Duration - 28 days
Participants resume usual alcohol consumption outside the laboratory. Blood samples are collected weekly over 28 days to monitor PEth levels and self-reported drinking behavior.
5 weekly visits with blood samples collected on Days 0, 7, 14, 21, and 28
Trial Site Locations
Total: 2 locations
1
University of North Texas
Denton, Texas, United States, 76201
Actively Recruiting
2
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
N
Nathalie Hill-Kapturczak, PhD
D
Donald Dougherty, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here