Phosphatidylethanol and Other Ethanol Consumption Markers

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer; Alcohol Consumption
• Intervention / Treatment: Other: Alcohol (Ethanol)

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie Hill-Kapturczak, PhD; Phone Number: 210-567-2725; Email: hillkapturcz@uthscsa.edu
• Study Contact Backup: Name: Donald Dougherty, PhD; Phone Number: 940-565-2649; Email: Donald.Dougherty@unt.edu

Study Locations

• United States
  • Texas
    • Denton, Texas, United States, 76201
      • Recruiting
      • University of North Texas
      • Contact: Donald Dougherty, PhD; Phone Number: 940-565-2649; Email: Donald.Dougherty@unt.edu
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center San Antonio
      • Contact: Nathalie Hill-Kapturczak, PhD; Phone Number: 210-567-2725; Email: hillkapturcz@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking; Up to 40 Healthy volunteers will 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 10 days of abstinence and 4 visits to provide 1 blood sample each time. These 40 participants will then consume alcohol as usual outside the laboratory for 28 days and blood will be collected weekly (Day 0, Day 7, Day 14, 21 and 28). A second cohort of 40 participants will then undergo the naturalistic portion with blood collected on Days 0, Day 7, Day 14, 21 and 28.

Other: Alcohol (Ethanol); Alcohol will be administered to participants by research staff. In Phase 1, participants will consume alcohol designed to produce a targeted blood alcohol concentration (BAC) of 0.06% using the modified Widmark equation.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Nathalie Hill-Kapturczak, PhD, The University of Texas Health Science Center at San Antonio; Principal Investigator: Donald Dougherty, PhD, University of North Texas Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Healthy adult; Light, moderate and heavy drinkers
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Anti-Infective Agents; Physiological Effects of Drugs; Central Nervous System Depressants; Anti-Infective Agents, Local; Ethanol
• Other Study ID Numbers: STUDY00000887; R01AA022361 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Public policy will focus on ensuring that all dissemination of deidentified individual participant research findings from this study is conducted in an accurate, transparent and ethical manner. Authorship will be determined based on significant contributions to the study's conception, design, data acquisition, analysis or interpretation as well as in drafting and critically revising the manuscript. All authors must approve the final version of the manuscript. The primary author will be the individual who has made the most significant contribution to the study, while co-authors will include those who have made substantial contributions.

Final copies of all publications, abstracts, and presentations will be archived in the study's repository and made accessible to all study personnel, including the submitted version and any subsequent revisions.

• IPD Sharing Time Frame: At the time of summary result reporting in ClinicalTrials.gov and when published in a peer review journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No