- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07758231
Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics (TAP)
5. august 2026 opdateret af: University of Wisconsin, Madison
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
5
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Heather Barkholtz, PhD
- Telefonnummer: 608-890-1967
- E-mail: hbarkholtz@wisc.edu
Undersøgelse Kontakt Backup
- Navn: Michael Chen, MD
- E-mail: michael.chen@fammed.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Ethanol Concentration (Cmax)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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
Tidsramme: 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.
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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
Tidsramme: 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.
|
prior to dosing (-25 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 350 minutes
|
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Ethanol Elimination Rate: Urine samples
Tidsramme: prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes
|
Data derived from urine samples.
|
prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Score
Tidsramme: 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.
|
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
Tidsramme: 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.
|
5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
|
|
Divided Attention Task (DAT)
Tidsramme: 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.
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prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
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Digital Symbol Substitution Task (DSST)
Tidsramme: 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.
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prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
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Paced Serial Addition Task (PSAT)
Tidsramme: prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
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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.
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prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Heather Barkholtz, PhD, UW School of Pharmacy
- Ledende efterforsker: Michael Chen, MD, UW School of Medicine and Public Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. marts 2027
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
5. august 2026
Først indsendt, der opfyldte QC-kriterier
5. august 2026
Først opslået (Faktiske)
11. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-1120
- Protocol Version 7/20/26 (Anden identifikator: UW Madison)
- Pharmacy | Pharmacy Practice (Anden identifikator: UW Madison)
- ICTR TBCR Pilot Award (Anden identifikator: UW Madison)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data, including transcriptions of audio-recordings of the driving simulator experiments and biological specimens, will be stored for future use.
The original digital audio recordings will not be banked for future use, only the transcription documents containing only experiment-relevant words spoken by the participant will be kept.
Only members of the study team will have access to the data and specimens.
Prior to banking, identifiers (including linking codes) will be removed from the data and biological specimens.
Since identifiers will be removed from the data and biological specimens, participants will not be able to withdraw their banked data and specimens from future research use.
Data will be released only as anonymized aggregates after careful consideration and approval of one of the study PIs.
No genetic testing will take place on any banked biological specimen.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .