Phosphatidylethanol and Other Ethanol Consumption Markers

Not Applicable

Recruiting

• Conditions: Healthy Volunteer; Alcohol Consumption

• Registration Number: NCT06747364
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

This study is intended to help the investigators understand how a biomarker found in the blood may be used to better identify the quantity and different patterns of alcohol use.

The investigators hope that the results of this study will help identify the uses of alcohol-use markers in the blood in future alcohol prevention and treatment programs. It is hoped that the information learned from this study will benefit other people in the future.

The study participants will come into the lab and will (1) consume alcohol in the lab designed to produce a peak blood alcohol concentration of 0.06% and have blood collected over 6 hours followed by abstinence for 10 days to give a small blood sample 4 times and (2) to give a small amount of blood 5 times within 28 days (naturalistic drinking) and provide answers about alcohol use.

Detailed Description

The study goal is to account for individual differences in biological variables likely influencing Phosphatidylethanol (PEth) formation to determine the extent to which the investigators can improve their ability to characterize alcohol consumed previously. Investigators propose three experiments that combine: (a) controlled human laboratory studies in vivo, (b) clinical laboratory studies of important enzymatic and biological variables measured ex vivo, and (c) the creation and testing of regression models to predict drinking during a naturalistic observational study using PEth levels and key biological variables identified in the lab.

Aim 1 is an in vivo pharmacokinetic study that whereby participants will consume a dose of alcohol to achieve a target blood alcohol concentration of 0.06%. Blood samples will be collected repeatedly during a 6-hour period to characterize blood/breath alcohol concentrations and PEth syntheses. Then PEth elimination half-life will be characterized across a 10-day period while remaining alcohol abstinent outside the lab.

In Aim 2, alcohol-free blood collected from Aim 1 will be examined ex vivo to characterize key biological variables (e.g., enzyme activity, red blood cell count, precursor levels) involved in PEth synthesis and elimination. Regression formulas will evaluate these variables for their ability to explain the previously unexplained between-subject differences in the PEth levels formed after the same amount of alcohol is consumed.

Finally, in Aim 3, regression equations will be used to evaluate the value of using these biological/enzyme variables to improve (above and beyond that of PEth alone) the prediction of naturalistic drinking self-reported by participants over a 28-day period.

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Study Start: 2025-01-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females	Baseline to 360 minutes	Measure of PEth level in ng/ml over 360 minutes
Breath alcohol concentrations on alcohol administration day in Males/Females	Baseline to 360 minutes	Measure of breath alcohol concentrations in g/dL over 360 minutes
PEth Concentrations for half-life in Males/Females	End of Day 0 to 10 days	Measure of PEth concentrations in ng/ml on days 0 (end of day), 3, 5, 7 and 10
PEth concentrations once weekly during 28 days naturalistic drinking in Males/Females	Baseline to 28 days	Measure of PEth level in ng/ml on days 0, 7, 14, 21 and 28
Self-reported drinking during the 28 days naturalistic drinking in Males/Females	Baseline to 28 days	TLFB on days 0, 7, 14, 21 and 28
PEth Concentrations during the 28 days naturalistic drinking in Males/Females	Baseline to 28 days	Measure of PEth concentrations in ng/ml on days 0, 7, 14, 21 and 28
Red blood cell count (RBC) in Males/Females	One time (baseline)]	Measurement of RBCs in cells/mm\^3
Phosphatidylcholine (PC) content in Males/Females	One time (baseline)	Measurement of PC content in ng/ml at baseline
Ex vivo PEth formation for PLD activity in blood from Males/Females	Baseline to 90 minutes	PEth concentrations in ng/mL at 0, 15, 30, 45, 60, and 90 min after alcohol exposure

Trial Locations

Locations (2)

University of North Texas; 🇺🇸 Denton, Texas, United States

University of Texas Health Science Center San Antonio; 🇺🇸 San Antonio, Texas, United States