Alcohol, GLP-1
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGAcute Ethanol Dose
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Prospective, single-site, open-label, single-arm pilot study evaluating the pharmacokinetics and pharmacodynamics of ethanol in participants receiving maintenance GLP-1 RA therapy
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Good mental health as determined by self-reported responses to the Psychopathology Screener and review by Study Physician as necessary * Absence of any major medical, cardiovascular, endocrine, and neurological condition as determined by self-reported responses to the Medical History Screener * In possession of a valid drivers' license with at least two years of driving experience * English-speaking (able to provide consent and complete questionnaires) * Written Informed Consent
Exclusion criteria
* 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) * Use of medications that may impact cognitive ability or potentiate alcohol (e.g., mood stabilizers, sedatives) * Use of medications that are known to significantly delay gastric emptying as determined by Study Physician * History of pancreatitis, severe gastroparesis, or personal or family history of medullary thyroid or multiple endocrine neoplasia syndrome type 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Ethanol Concentration (Cmax) | 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 | Cmax will be determined from visual inspection of the concentration-time plots. |
| Time to Maximum Ethanol Concentration (Tmax) | 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 | Tmax will be determined from visual inspection of the concentration-time plots. |
| Ethanol Elimination Rate: Blood samples | 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 | Data derived from blood samples. |
| Ethanol Elimination Rate: Breath tests | prior to dosing (-25 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes | Data derived from breath alcohol test. |
| Ethanol Elimination Rate: Urine samples | prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes | Data derived from urine samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biphasic Alcohol Effects Scale (BAES) Score | 5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes | 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 | 5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes | 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) | prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes | 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) | prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes | 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. |
| Paced Serial Addition Task (PSAT) | prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes | 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. |
Countries
United States
Contacts
CONTACTHeather Barkholtz, PhD
CONTACTMichael Chen, MD
PRINCIPAL_INVESTIGATORHeather Barkholtz, PhD
UW School of Pharmacy
PRINCIPAL_INVESTIGATORMichael Chen, MD
UW School of Medicine and Public Health
Outcome results
None listed