Clinical trial · Interventional
Phosphatidylethanol and Other Ethanol Consumption Markers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol Consumption | — | UNRESOLVED | — |
| Healthy Volunteer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alcohol (Ethanol) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking
- description
- 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.
- interventionNames
- Other: Alcohol (Ethanol)
Primary outcomes (9)
- measure
- Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females
- timeFrame
- Baseline to 360 minutes
- description
- Measure of PEth level in ng/ml over 360 minutes
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available