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NCT Number: NCT06747364

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.

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Key information

Conditions

Healthy Volunteer Alcohol Consumption Alcohol Drinking Behavior Drinking Behavior Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Texas, Denton, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • are ≥ 21 years old;
  • are height and weight proportionate (body mass index 18-30); and
  • report drinking on > 1 days in the last month, with at least one day equal to at least achieving ~0.06% BAC.

Exclusion criteria

  • have significant current or predicted alcohol withdrawal symptoms (CIWA-AR scores ≥ 10);
  • are currently in alcohol treatment;
  • have substance use disorder (except nicotine, and/or caffeine);
  • have a medical condition that would contraindicate participation (a positive urine pregnancy test, self-reported scheduled surgery or liver disease);
  • are currently breast feeding;
  • have a presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium; or
  • are unable to comprehend the informed consent process or study instructions.

Treatment and study plan

Alcohol (Ethanol)

Other

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.

Primary outcomes

  1. Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females

    Time frame: Baseline to 360 minutes

    Measure of PEth level in ng/ml over 360 minutes

  2. Breath alcohol concentrations on alcohol administration day in Males/Females

    Time frame: Baseline to 360 minutes

    Measure of breath alcohol concentrations in g/dL over 360 minutes

  3. PEth Concentrations for half-life in Males/Females

    Time frame: 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

  4. PEth concentrations once weekly during 28 days naturalistic drinking in Males/Females

    Time frame: Baseline to 28 days

    Measure of PEth level in ng/ml on days 0, 7, 14, 21 and 28

  5. Self-reported drinking during the 28 days naturalistic drinking in Males/Females

    Time frame: Baseline to 28 days

    TLFB on days 0, 7, 14, 21 and 28

  6. PEth Concentrations during the 28 days naturalistic drinking in Males/Females

    Time frame: Baseline to 28 days

    Measure of PEth concentrations in ng/ml on days 0, 7, 14, 21 and 28

  7. Red blood cell count (RBC) in Males/Females

    Time frame: One time (baseline)]

    Measurement of RBCs in cells/mm^3

  8. Phosphatidylcholine (PC) content in Males/Females

    Time frame: One time (baseline)

    Measurement of PC content in ng/ml at baseline

  9. Ex vivo PEth formation for PLD activity in blood from Males/Females

    Time frame: Baseline to 90 minutes

    PEth concentrations in ng/mL at 0, 15, 30, 45, 60, and 90 min after alcohol exposure

Study contacts

Contact information is provided by the study sponsor or research team.

Donald Dougherty, PhD

CONTACT

[email protected]

940-565-2649

Nathalie Hill-Kapturczak, PhD

CONTACT

[email protected]

210-567-2725

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 24, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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