An interventional study of Alcohol (Ethanol) in Healthy Volunteer and Alcohol Consumption, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Basic science
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.
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.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's planned enrollment of 80 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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.
Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females
Measure of PEth level in ng/ml over 360 minutes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 28 days
Red blood cell count (RBC) in Males/Females
Measurement of RBCs in cells/mm\^3
Time frame: One time (baseline)]
Phosphatidylcholine (PC) content in Males/Females
Measurement of PC content in ng/ml at baseline
Time frame: 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
Time frame: Baseline to 90 minutes
Plan to share: Yes — Public policy will focus on ensuring that all dissemination of deidentified individual participant research findings from this study is conducted in an accurate, transparent and ethical manner. Authorship will be determined based on significant contributions to the study's conception, design, data acquisition, analysis or interpretation as well as in drafting and critically revising the manuscript. All authors must approve the final version of the manuscript. The primary author will be the individual who has made the most significant contribution to the study, while co-authors will include those who have made substantial contributions. Final copies of all publications, abstracts, and presentations will be archived in the study's repository and made accessible to all study personnel, including the submitted version and any subsequent revisions.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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The University of Texas Health Science Center at San Antonio