Phosphatidylethanol and Other Ethanol Consumption Markers

NCT ID: NCT06747364

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2029-06-30

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.

Conditions

Healthy Volunteer; Alcohol Consumption

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Alcohol (Ethanol)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Nathalie Hill-Kapturczak

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalie Hill-Kapturczak, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Donald Dougherty, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Texas Health Science Center

Locations

University of North Texas

Denton, Texas, United States

Site Status: RECRUITING

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nathalie Hill-Kapturczak, PhD

Role: CONTACT

Hillkapturcz@uthscsa.edu

210-567-2725

Donald Dougherty, PhD

Role: CONTACT

Donald.Dougherty@unt.edu

940-565-2649

Facility Contacts

Donald Dougherty, PhD

Role: primary

Donald.Dougherty@unt.edu

940-565-2649

Nathalie Hill-Kapturczak, PhD

Role: primary

hillkapturcz@uthscsa.edu

210-567-2725

Other Identifiers

R01AA022361

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000887

Identifier Type: -

Identifier Source: org_study_id