Alcohol for Studying Alcohol Consumption

Recruiting at 1 trial location

Overseen By Donald Dougherty, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Alcohol withdrawal, Alcohol treatment, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Phosphatidylethanol for studying alcohol consumption?

Phosphatidylethanol (PEth) is effective as a biomarker (a measurable indicator) for alcohol consumption, as studies show it correlates strongly with self-reported alcohol intake and AUDIT scores (a test for alcohol use disorders). This suggests it can reliably indicate different levels of drinking habits. ^{1 2 3 4 5}

Is phosphatidylethanol safe for humans?

The research articles focus on measuring phosphatidylethanol (PEth) levels in the blood to assess alcohol consumption, but they do not provide specific safety data about using PEth as a treatment. The studies primarily discuss PEth as a biomarker for alcohol intake rather than evaluating its safety as a treatment. ^{1 4 5 6 7}

How is the treatment Phosphatidylethanol different from other treatments for alcohol consumption?

Phosphatidylethanol (PEth) is unique because it is not a treatment for alcohol consumption but a biomarker used to monitor alcohol intake. It is highly sensitive and specific, providing a reliable measure of long-term alcohol use by detecting ethanol-derived phospholipids in the blood. ^{8 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

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

Eligibility Criteria

This trial is for healthy individuals interested in helping researchers understand how a blood biomarker can indicate the amount and patterns of alcohol use. Participants will consume alcohol under lab conditions and provide multiple blood samples over a period of days.

Inclusion Criteria

My BMI is between 18 and 30.

Report drinking on > 1 days in the last month, with at least one day equal to at least achieving ~0.06% BAC.

I am 21 years old or older.

Exclusion Criteria

Have substance use disorder (except nicotine, and/or caffeine)

Have significant current or predicted alcohol withdrawal symptoms (CIWA-AR scores ≥ 10)

Currently breast feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-lab Alcohol Consumption

Participants consume alcohol in the lab to achieve a peak blood alcohol concentration of 0.06% and have blood collected over 6 hours.

1 day

1 visit (in-person)

Abstinence and Monitoring

Participants remain abstinent from alcohol for 10 days with blood samples collected to characterize PEth elimination.

10 days

4 visits (in-person)

Naturalistic Drinking Observation

Participants consume alcohol as usual outside the laboratory for 28 days with weekly blood collection.

28 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the naturalistic drinking phase.

4 weeks

Treatment Details

Interventions

• Phosphatidylethanol

Trial Overview The study tests how well a specific biomarker in the blood, Phosphatidylethanol, reflects alcohol consumption levels. Participants will drink controlled amounts of alcohol to achieve a set blood concentration and then give several blood samples.

Participant Groups

Group I: In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a study of 24,574 adults from Norway, higher phosphatidylethanol (PEth) levels in blood were strongly associated with increased self-reported alcohol consumption, binge drinking, and higher CAGE scores, indicating a reliable biomarker for alcohol intake.

Optimal PEth cut-off concentrations were identified for different levels of alcohol consumption, with 0.057 μmol/l effectively identifying those consuming more than 1 unit per day, suggesting that these thresholds can help in assessing alcohol use and guiding further interviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying Alcohol Consumption in the General Population by Analysing Phosphatidylethanol Concentrations in Whole Blood: Results from 24,574 Subjects Included in the HUNT4 Study. Skråstad, RB., Aamo, TO., Andreassen, TN., et al.[2023]

In a study of 34 patients with alcohol use disorder undergoing detoxification, higher levels of phosphatidylethanol (PEth) in the blood were significantly correlated with more severe alcohol withdrawal symptoms, as measured by the alcohol withdrawal syndrome (AWS) scale.

Patients whose AWS scores reached 6 or more, indicating a need for medication, had higher median PEth levels, suggesting that PEth could be a useful biomarker for identifying individuals at risk for severe withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Biomarker Phosphatidylethanol as a Predictor of the Severity of Alcohol Withdrawal Syndrome. Novak, L., Soravia, LM., Bünter, A., et al.[2023]

Phosphatidylethanol (PEth) is a reliable biomarker for detecting alcohol consumption among injecting drug users, showing strong associations with self-reported alcohol use in a study involving young IDUs.

The study found that 94% of participants who reported abstaining from alcohol tested negative for PEth, indicating high specificity, and PEth levels correlated well with the frequency of reported drinking, suggesting its potential utility in validating self-reported alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of phosphatidylethanol results to self-reported alcohol consumption among young injection drug users. Jain, J., Evans, JL., Briceño, A., et al.[2021]

In a study of 103 young adults, binge drinkers had significantly higher levels of phosphatidylethanol (PEth) in their blood compared to moderate drinkers and abstainers, indicating a strong biological marker for heavy alcohol consumption.

There was a strong positive correlation between PEth levels and self-reported alcohol intake as measured by the AUDIT scores, suggesting that PEth can effectively reflect actual drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phosphatidylethanol Levels Are Elevated and Correlate Strongly with AUDIT Scores in Young Adult Binge Drinkers. Piano, MR., Tiwari, S., Nevoral, L., et al.[2015]

A study involving 300 healthy volunteers established that phosphatidylethanols (PEth) levels in the blood are strongly correlated with self-reported alcohol consumption, indicating their potential as reliable biomarkers for monitoring drinking habits.

PEth concentrations below 10.0 ng/mL were associated with abstinence or light drinking (≤10g pure alcohol/day), while higher levels indicated excessive alcohol consumption, suggesting that PEth can effectively differentiate between varying levels of alcohol intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing phosphatidylethanol (PEth) levels reflecting different drinking habits in comparison to the alcohol use disorders identification test - C (AUDIT-C). Schröck, A., Wurst, FM., Thon, N., et al.[2018]

The study analyzed the pharmacokinetics of the PEth 16:0/20:4 homolog in 18 participants after consuming two doses of ethanol, revealing that its levels increased less than other PEth homologs (16:0/18:1 and 16:0/18:2) within the first 6 hours post-consumption.

PEth 16:0/20:4 had a mean half-life of 2.1 days, which is shorter than the half-lives of the other homologs, suggesting that measuring multiple PEth types can provide a more comprehensive understanding of alcohol consumption patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Phosphatidylethanol 16:0/20:4 in Human Blood After Alcohol Intake. Lopez-Cruzan, M., Roache, JD., Hill-Kapturczak, N., et al.[2022]

In a study involving 27 participants who consumed low doses of ethanol, the levels of combined phosphatidylethanol (PEth) in blood samples increased proportionally with blood alcohol concentrations, indicating that PEth is a reliable biomarker for detecting low levels of alcohol consumption.

The mean half-life of combined PEth was found to be approximately 4.6 days, suggesting that it can remain detectable in the body for an extended period after alcohol intake, which enhances its utility in monitoring alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of the Pharmacokinetics of Phosphatidylethanol 16:0/18:1 and 16:0/18:2 in Human Whole Blood After Alcohol Consumption in a Clinical Laboratory Study. Javors, MA., Hill-Kapturczak, N., Roache, JD., et al.[2018]

A new automated sample preparation method using Phree™ Phospholipid Removal Plates was developed for extracting phosphatidylethanols (PEths) from whole blood, which is simpler and more cost-effective than traditional extraction techniques.

This method was validated according to FDA guidelines and demonstrated high sensitivity and specificity for detecting PEths, making it a reliable tool for monitoring long-term alcohol consumption in clinical and forensic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated sample preparation approach for routine liquid chromatography tandem-mass spectrometry measurement of the alcohol biomarkers phosphatidylethanol 16:0/18:1, 16:0/16:0 and 18:1/18:1. Casati, S., Ravelli, A., Angeli, I., et al.[2019]

In a study of 49 patients with alcohol use disorder, it was found that PEth concentrations can remain above the clinically significant cutoff of 200 ng/ml even after 6 weeks of abstinence, indicating a longer elimination time than previously thought.

There is a strong correlation between initial PEth levels and the time it takes for levels to drop below the 200 and 20 ng/ml cutoffs, suggesting that multiple measurements of PEth are necessary to accurately assess alcohol consumption behavior in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Phosphatidylethanol Elimination in Alcohol Use Disorder Patients Undergoing Withdrawal Treatment. Stöth, F., Weinmann, W., Soravia, LM., et al.[2023]

A new analytical method for detecting phosphatidylethanols (PEths) in blood has been developed, allowing for the monitoring of chronic alcohol consumption with high accuracy and low sample volume (only 50 μL needed).

In a study of 248 pregnant women, 6.9% tested positive for PEth, demonstrating the method's applicability in clinical settings to identify alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of Phosphatidylethanols in Whole Blood as a Proxy for Chronic Alcohol Consumption, Using Ultra Performance Convergence Chromatography Tandem Mass Spectrometry. van der Nagel, BCH., Wassenaar, S., Bahmany, S., et al.[2018]

The study found that levels of PEth, a metabolite of ethanol, accumulate in the blood of rhesus macaque monkeys after daily ethanol consumption, indicating its potential as a reliable biomarker for alcohol intake.

PEth levels were strongly correlated with the amount of ethanol consumed in the previous 14 days, and established human cutoff concentrations for PEth effectively predicted different levels of alcohol consumption in these monkeys, suggesting that this model can help understand variability in PEth levels among humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phosphatidylethanol in whole blood of rhesus monkeys correlates with ethanol consumption. Lopez-Cruzan, M., Walter, NAR., Sanchez, JJ., et al.[2023]

A new LC-MS method was developed to measure different species of the alcohol biomarker phosphatidylethanol (PEth) in human blood, allowing for both qualitative and quantitative analysis.

In a study of 38 alcohol patients, the total PEth concentration varied widely, with the predominant species being PEth-16:0/18:1 and PEth-16:0/18:2, indicating the method's effectiveness in detecting and analyzing alcohol consumption biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular species of the alcohol biomarker phosphatidylethanol in human blood measured by LC-MS. Helander, A., Zheng, Y.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Quantifying Alcohol Consumption in the General Population by Analysing Phosphatidylethanol Concentrations in Whole Blood: Results from 24,574 Subjects Included in the HUNT4 Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Alcohol Biomarker Phosphatidylethanol as a Predictor of the Severity of Alcohol Withdrawal Syndrome. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of phosphatidylethanol results to self-reported alcohol consumption among young injection drug users. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Phosphatidylethanol Levels Are Elevated and Correlate Strongly with AUDIT Scores in Young Adult Binge Drinkers. [2015]

5. Ireland pubmed.ncbi.nlm.nih.gov

Assessing phosphatidylethanol (PEth) levels reflecting different drinking habits in comparison to the alcohol use disorders identification test - C (AUDIT-C). [2018]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Phosphatidylethanol 16:0/20:4 in Human Blood After Alcohol Intake. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Characterization of the Pharmacokinetics of Phosphatidylethanol 16:0/18:1 and 16:0/18:2 in Human Whole Blood After Alcohol Consumption in a Clinical Laboratory Study. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

An automated sample preparation approach for routine liquid chromatography tandem-mass spectrometry measurement of the alcohol biomarkers phosphatidylethanol 16:0/18:1, 16:0/16:0 and 18:1/18:1. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of Phosphatidylethanol Elimination in Alcohol Use Disorder Patients Undergoing Withdrawal Treatment. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Quantification of Phosphatidylethanols in Whole Blood as a Proxy for Chronic Alcohol Consumption, Using Ultra Performance Convergence Chromatography Tandem Mass Spectrometry. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Phosphatidylethanol in whole blood of rhesus monkeys correlates with ethanol consumption. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Molecular species of the alcohol biomarker phosphatidylethanol in human blood measured by LC-MS. [2019]