This study is to learn how the weight loss drug tirzepatide (Zepbound) changes the way a body handles alcohol. 5 participants aged 21-55 who take Zepbound will be enrolled and can expect to be on study for up to 4 weeks.
Participants will: * Arrive to study visit in a fasted state * Provide blood, breath, and urine samples prior to intervention * Complete baseline cognitive assessments * Self-administer the intervention (time 0), followed by breakfast (time 30 minutes) * Complete subjective and cognitive assessments throughout treatment visit * Provide blood, breath, and urine samples throughout treatment visit * Consume lunch 260 minutes after dosing * Complete study visit at 360 minutes * Complete a final study survey Primary Objective: Characterize the pharmacokinetics of ethanol in participants receiving maintenance Glucagon-like peptide-1 (GLP-1) receptor agonist (RA) therapy (tirzepatide). Secondary Objectives: \- Determine the effects of GLP-1 RA therapy on alcohol-induced impairment, as measured by * objective performance * subjective impairment assessments * risk perception Correlative Objectives * Define the exposure-response relationship between biological alcohol concentrations (breath and blood) and functional impairment to determine if Primary Objective * Characterize the pharmacokinetics of ethanol in participants receiving maintenance GLP-1 RA therapy (tirzepatide).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
5
Time 0, participants will self-administer an oral ethanol beverage (vodka and sugar-free cherry Kool aid) calculated to reach a peak Breath Alcohol Concentration (BrAC) of 0.08 g/dL using the Widmark formula. A total time of 30 minutes will be given for completion of beverage consumption. This will be followed by a breakfast.
University of Wisconsin
Madison, Wisconsin, United States
Maximum Ethanol Concentration (Cmax)
Cmax will be determined from visual inspection of the concentration-time plots.
Time frame: prior to dosing (-25 minutes), start of dosing (0 minutes), 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes
Time to Maximum Ethanol Concentration (Tmax)
Tmax will be determined from visual inspection of the concentration-time plots.
Time frame: prior to dosing (-25 minutes), start of dosing (0 minutes), 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes
Ethanol Elimination Rate: Blood samples
Data derived from blood samples.
Time frame: prior to dosing (-25 minutes), start of dosing (0 minutes), 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes
Ethanol Elimination Rate: Breath tests
Data derived from breath alcohol test.
Time frame: prior to dosing (-25 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes
Ethanol Elimination Rate: Urine samples
Data derived from urine samples.
Time frame: prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes
Biphasic Alcohol Effects Scale (BAES) Score
The BAES has 2 subscales: Stimulant scored from 0-70 and Sedative scored from 0-70. Higher scores indicate higher stimulant or sedative effects.
Time frame: 5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
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Risk Perception and Safety Appraisal (RPSA) Score
To quantify cognitive and affective dimensions of risk perception, participants will complete the RPSA questionnaire assessing cognitive and affective risk perception, behavioral risk willingness, metacognitive calibration, and consequence awareness. This RPSA has been designed by the study team to provide a low burden (12-item), repeatable measure of cognitive, affective, and behavioral dimensions of risk perception, and direct quantification of willingness to engage in safety sensitive behavior. Scores range from 0-100 where higher scores indicate increased risk perception.
Time frame: 5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
Divided Attention Task (DAT)
Participants will be asked to complete a computer-based DAT on a laptop in their room. The DAT requires participants to track a moving stimulus on a computer screen while simultaneously monitoring numbers located in the corners of the screen. Participants must respond to target numbers as they appear, and the task quantifies the mean distance of the mouse cursor from the center of the target stimulus.
Time frame: prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
Digital Symbol Substitution Task (DSST)
Participants will be asked to complete a computer-based DSST on a laptop in their room. The DSST asks participants to recreate patterns of various shapes presented on a computer screen using the keyboard. The total number of correct patterns are recorded within 90 seconds.
Time frame: prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
Paced Serial Addition Task (PSAT)
Participants will be asked to complete a computer-based PSAT on a laptop in their room. The PSAT has participants view a string of single-digit numbers and calculate the sum of the two most recently presented numbers. The total number of correct trials out of 90 will be recorded.
Time frame: prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes