Clinical trial NCT06747364: Phosphatidylethanol and Other Ethanol Consumption Markers
Official title: Phosphatidylethanol and Other Ethanol Consumption Markers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteer
Alcohol Consumption
Keywords: Healthy adult
Light, moderate and heavy drinkers
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-12-24
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females
timeFrame: Baseline to 360 minutes
measure: Breath alcohol concentrations on alcohol administration day in Males/Females
timeFrame: Baseline to 360 minutes
measure: PEth Concentrations for half-life in Males/Females
timeFrame: End of Day 0 to 10 days
measure: PEth concentrations once weekly during 28 days naturalistic drinking in Males/Females
timeFrame: Baseline to 28 days
measure: Self-reported drinking during the 28 days naturalistic drinking in Males/Females
timeFrame: Baseline to 28 days
measure: PEth Concentrations during the 28 days naturalistic drinking in Males/Females
timeFrame: Baseline to 28 days
measure: Red blood cell count (RBC) in Males/Females
timeFrame: One time (baseline)]
measure: Phosphatidylcholine (PC) content in Males/Females
timeFrame: One time (baseline)
measure: Ex vivo PEth formation for PLD activity in blood from Males/Females
timeFrame: Baseline to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denton
country: United States
facility: University of North Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Nathalie Hill-Kapturczak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Texas Health Science Center
name: Donald Dougherty, PhD
role: PRINCIPAL_INVESTIGATOR
References: