About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 21 years of age, no older than 55 years of age
BMI 30-45 kg/m2
Taking stable dose of prescribed, branded tirzepatide for at least 28 days
Self-reported regular alcohol consumption
Disqualifiers
AUDIT score of >8 requires Study Physician review
Use of compounded GLP-1 RA
History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener, Drug Use Disorders Identification Test, Alcohol Use Disorder Identification Test
Pregnancy or lactation (pregnancy test, if needed)
Trial design
Single group
Treatments tested in this trial
Acute Ethanol Dose
DrugTime 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.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Ethanol Concentration (Cmax)
Cmax will be determined from visual inspection of the concentration-time plots.
Time to Maximum Ethanol Concentration (Tmax)
Tmax will be determined from visual inspection of the concentration-time plots.
Ethanol Elimination Rate: Blood samples
Data derived from blood samples.
Ethanol Elimination Rate: Breath tests
Data derived from breath alcohol test.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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