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NCT07758231
Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics
Conditions: GLP-1, Alcohol
Sex: All
Ages: 21 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 5
Sponsor: University of Wisconsin, Madison
Location: University of Wisconsin Madison Wisconsin
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07758231). StuddyBuddy aggregates publicly available trial information.