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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA022361 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females | Measure of PEth level in ng/ml over 360 minutes | 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 | 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 | 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 | 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 | 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 | Baseline to 28 days |
| Red blood cell count (RBC) in Males/Females | Measurement of RBCs in cells/mm^3 | One time (baseline)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Hill-Kapturczak, PhD | Contact | 210-567-2725 | Hillkapturcz@uthscsa.edu | |
| Donald Dougherty, PhD | Contact | 940-565-2649 | Donald.Dougherty@unt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie Hill-Kapturczak, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Donald Dougherty, PhD | University of North Texas Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Texas | Recruiting | Denton | Texas | 76201 | United States |
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.
At the time of summary result reporting in ClinicalTrials.gov and when published in a peer review journal.
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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).
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| Phosphatidylcholine (PC) content in Males/Females |
Measurement of PC content in ng/ml at baseline |
| 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 | Baseline to 90 minutes |
| University of Texas Health Science Center San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |