Recruiting

Phosphatidylethanol

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06747364

Conditions

Healthy Volunteer

Alcohol Consumption

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Alcohol (Ethanol)

Study Details

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

Study ID

NCT06747364

Start date

Jan 7, 2025

Status verified date

May, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females [ Time Frame: Baseline to 360 minutes ]
  • Breath alcohol concentrations on alcohol administration day in Males/Females [ Time Frame: Baseline to 360 minutes ]
  • PEth Concentrations for half-life in Males/Females [ Time Frame: End of Day 0 to 10 days ]
  • PEth concentrations once weekly during 28 days naturalistic drinking in Males/Females [ Time Frame: Baseline to 28 days ]
  • Self-reported drinking during the 28 days naturalistic drinking in Males/Females [ Time Frame: Baseline to 28 days ]
  • PEth Concentrations during the 28 days naturalistic drinking in Males/Females [ Time Frame: Baseline to 28 days ]
  • Red blood cell count (RBC) in Males/Females [ Time Frame: One time (baseline)] ]
  • Phosphatidylcholine (PC) content in Males/Females [ Time Frame: One time (baseline) ]
  • Ex vivo PEth formation for PLD activity in blood from Males/Females [ Time Frame: Baseline to 90 minutes ]

Central Contacts and Locations

Central contacts

Nathalie Hill-Kapturczak, PhD

210-567-2725Hillkapturcz@uthscsa.edu

Donald Dougherty, PhD

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

Locations

University of North Texas

Recruiting

Denton, Texas, United States, 76201

Contacts

Donald Dougherty, PhD

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

University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Nathalie Hill-Kapturczak, PhD

210-567-2725hillkapturcz@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • Healthy adult
  • Light, moderate and heavy drinkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-05-13.