RecruitingRecruiting
Phosphatidylethanol and Other Ethanol Consumption Markers
NCT06747364 · The University of Texas Health Science Center at San Antonio
In plain English
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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.
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.
Study design
Enrollment target: 80 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-07
Estimated completion: 2029-06
Last updated: 2025-05-13
Interventions
Other: Alcohol (Ethanol)
Primary outcomes
- • Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females (Baseline to 360 minutes)
- • Breath alcohol concentrations on alcohol administration day in Males/Females (Baseline to 360 minutes)
- • PEth Concentrations for half-life in Males/Females (End of Day 0 to 10 days)
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contacts & investigators
ContactNathalie Hill-Kapturczak, PhD · contact · Hillkapturcz@uthscsa.edu · 210-567-2725
ContactDonald Dougherty, PhD · contact · Donald.Dougherty@unt.edu · 940-565-2649
InvestigatorNathalie Hill-Kapturczak, PhD · principal_investigator, The University of Texas Health Science Center at San Antonio
InvestigatorDonald Dougherty, PhD · principal_investigator, University of North Texas Health Science Center
All locations (2)
University of North TexasRecruiting
Denton, Texas, United States
University of Texas Health Science Center San AntonioRecruiting
San Antonio, Texas, United States