Healthy VolunteerNCT06747364
Phosphatidylethanol and Other Ethanol Consumption Markers
A study testing Alcohol (Ethanol) in people with Healthy Volunteer and Alcohol Consumption, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Alcohol Consumption
- What is being tested?
- Alcohol (Ethanol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are ≥ 21 years old;
- are height and weight proportionate (body mass index 18-30); and
- report drinking on > 1 days in the last month, with at least one day equal to at least achieving ~0.06% BAC.
Who cannot join
- have significant current or predicted alcohol withdrawal symptoms (CIWA-AR scores ≥ 10);
- are currently in alcohol treatment;
- have substance use disorder (except nicotine, and/or caffeine);
- have a medical condition that would contraindicate participation (a positive urine pregnancy test, self-reported scheduled surgery or liver disease);
- are currently breast feeding;
- have a presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium; or
- are unable to comprehend the informed consent process or study instructions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of North Texas
Denton, Texas, 76201
Donald Dougherty, PhD, 940-565-2649, Donald.Dougherty@unt.edu
- Recruiting
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Nathalie Hill-Kapturczak, PhD, 210-567-2725, hillkapturcz@uthscsa.edu
About this study
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.
Read the 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
- Being tested
- Alcohol (Ethanol)
- Keywords
- Healthy adult, Light, moderate and heavy drinkers
- Medical subject headings
- Alcohol Drinking, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol (Ethanol)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.
| Study group | Role | What they receive |
|---|---|---|
| In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking | Experimental | 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. Receives: Other: Alcohol (Ethanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females
Measure of PEth level in ng/ml over 360 minutes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 28 days
Red blood cell count (RBC) in Males/Females
Measurement of RBCs in cells/mm^3
Measured: One time (baseline)]
Phosphatidylcholine (PC) content in Males/Females
Measurement of PC content in ng/ml at baseline
Measured: 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
Measured: Baseline to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start7 Jan 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Nathalie Hill-Kapturczak, The University of Texas Health Science Center at San Antonio
- Investigators
- Nathalie Hill-Kapturczak, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioDonald Dougherty, PhD, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747364
- Sponsor's protocol ID
- STUDY00000887
- Other IDs
- R01AA022361
- Status last verified
- May 2025
- First submitted
- 18 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphatidylethanol and Other Ethanol Consumption Markers
- ClinicalTrials.gov ID
- NCT06747364
- Acronym / sponsor ID
- STUDY00000887
- Conditions
- Healthy Volunteer, Alcohol Consumption
- Keywords
- Healthy adult, Light, moderate and heavy drinkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking | Experimental | Other: Alcohol (Ethanol)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are ≥ 21 years old;
- are height and weight proportionate (body mass index 18-30); and
- report drinking on > 1 days in the last month, with at least one day equal to at least achieving ~0.06% BAC.
Key exclusion criteria (7 listed)
- have significant current or predicted alcohol withdrawal symptoms (CIWA-AR scores ≥ 10);
- are currently in alcohol treatment;
- have substance use disorder (except nicotine, and/or caffeine);
- have a medical condition that would contraindicate participation (a positive urine pregnancy test, self-reported scheduled surgery or liver disease);
- are currently breast feeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking |
Primary outcome
Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females
Time frame: Baseline to 360 minutes
Measure of PEth level in ng/ml over 360 minutes
Breath alcohol concentrations on alcohol administration day in Males/Females
Time frame: Baseline to 360 minutes
Measure of breath alcohol concentrations in g/dL over 360 minutes
PEth Concentrations for half-life in Males/Females
Time frame: End of Day 0 to 10 days
Measure of PEth concentrations in ng/ml on days 0 (end of day), 3, 5, 7 and 10
PEth concentrations once weekly during 28 days naturalistic drinking in Males/Females
Time frame: Baseline to 28 days
Measure of PEth level in ng/ml on days 0, 7, 14, 21 and 28
Self-reported drinking during the 28 days naturalistic drinking in Males/Females
Time frame: Baseline to 28 days
TLFB on days 0, 7, 14, 21 and 28
PEth Concentrations during the 28 days naturalistic drinking in Males/Females
Time frame: Baseline to 28 days
Measure of PEth concentrations in ng/ml on days 0, 7, 14, 21 and 28
Red blood cell count (RBC) in Males/Females
Time frame: One time (baseline)]
Measurement of RBCs in cells/mm^3
Phosphatidylcholine (PC) content in Males/Females
Time frame: One time (baseline)
Measurement of PC content in ng/ml at baseline
Ex vivo PEth formation for PLD activity in blood from Males/Females
Time frame: Baseline to 90 minutes
PEth concentrations in ng/mL at 0, 15, 30, 45, 60, and 90 min after alcohol exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie Hill-Kapturczak, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Donald Dougherty, PhD principal investigator
University of North Texas Health Science Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol (Ethanol) in people with Healthy Volunteer and Alcohol Consumption, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Hill-Kapturczak, PhD (210-567-2725, Hillkapturcz@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females (time frame: Baseline to 360 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.