Phosphatidylethanol and Other Ethanol Consumption Markers

Part of paid clinical trials in Denton, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06747364
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol Consumption
  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Jan 7, 2025
Status verified
May 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinking
    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.

Primary Outcome Measure

Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females [ Time Frame: Baseline to 360 minutes ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of North TexasDentonTexas76201
Donald Dougherty, PhD
[email protected]
940-565-2649
University of Texas Health Science Center San AntonioSan AntonioTexas78229
Nathalie Hill-Kapturczak, PhD
[email protected]
210-567-2725

Find similar trials in Denton, TX

By research site
University of North Texas· Denton, TXUniversity of Texas Health Science Center San Antonio· San Antonio, TX

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