Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Maximum Ethanol Concentration (Cmax)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Healthy adults on Tirzepatide
Participants will complete a screening and enrollment visit, one study visit, and a follow-up correspondence over the course of approximately 4 weeks.
Intervention: Acute Ethanol Dose (Drug)
Outcomes
Primary Outcomes
Maximum Ethanol Concentration (Cmax)
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
Cmax will be determined from visual inspection of the concentration-time plots.
Time to Maximum Ethanol Concentration (Tmax)
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
Tmax will be determined from visual inspection of the concentration-time plots.
Ethanol Elimination Rate: 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
Data derived from blood samples.
Ethanol Elimination Rate: Breath tests
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
Data derived from breath alcohol test.
Ethanol Elimination Rate: Urine samples
Time Frame: prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes
Data derived from urine samples.
Secondary Outcomes
- Biphasic Alcohol Effects Scale (BAES) Score(5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes)
- 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)
- Divided Attention Task (DAT)(prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes)
- Digital Symbol Substitution Task (DSST)(prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes)
- Paced Serial Addition Task (PSAT)(prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes)