Phosphatidylethanol and Other Ethanol Consumption Markers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorThe University of Texas Health Science Center at San Antonio
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
Alcohol (Ethanol)
Other interventionAlcohol 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: In Lab alcohol consumption followed by 10 days of abstinence and then 28-days naturalistic drinkingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phosphatidylethanol (PEth) concentrations on alcohol administration day in Males/Females
Measure of PEth level in ng/ml over 360 minutes
Time frame
Baseline to 360 minutes2
Breath alcohol concentrations on alcohol administration day in Males/Females
Measure of breath alcohol concentrations in g/dL over 360 minutes
Time frame
Baseline to 360 minutes3
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
Time frame
End of Day 0 to 10 days4
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
Time frame
Baseline to 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov