Phosphatidylethanol and Other Ethanol Consumption Markers

NCT06747364 | Recruiting DMC

• 2 other identifiers: STUDY00000887R01AA022361
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteer; Alcohol Consumption

Keywords

Healthy adult; Light, moderate and heavy drinkers

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking

EXPERIMENTAL

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)

Interventions

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.

In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of North Texas

Denton, Texas, 76201, United States

RECRUITING

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Lymphoma, Follicular

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Hill-Kapturczak, PhD

CONTACT

210-567-2725; Hillkapturcz@uthscsa.edu

Donald Dougherty, PhD

CONTACT

940-565-2649; Donald.Dougherty@unt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The alcohol administration study will occur at the Applied Physiology Laboratory (APL) at UNT. The naturalistic drinking study will occur at UNT and a 2nd cohort will undergo a naturalistic drinking study at UTHSCSA Behavioral Research Lab (BRL).

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the time of summary result reporting in ClinicalTrials.gov and when published in a peer review journal.

Locations

US (2)