- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07758231
Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics (TAP)
5. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert 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).
Studietype
Intervensjonell
Registrering (Antatt)
5
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Heather Barkholtz, PhD
- Telefonnummer: 608-890-1967
- E-post: hbarkholtz@wisc.edu
Studer Kontakt Backup
- Navn: Michael Chen, MD
- E-post: michael.chen@fammed.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
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
|
|
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 |
Tiltaksbeskrivelse |
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.
|
prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
|
|
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.
|
prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
|
|
Paced Serial Addition Task (PSAT)
Tidsramme: 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.
|
prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Heather Barkholtz, PhD, UW School of Pharmacy
- Hovedetterforsker: Michael Chen, MD, UW School of Medicine and Public Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mars 2027
Datoer for studieregistrering
Først innsendt
5. august 2026
Først innsendt som oppfylte QC-kriteriene
5. august 2026
Først lagt ut (Faktiske)
11. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026-1120
- Protocol Version 7/20/26 (Annen identifikator: UW Madison)
- Pharmacy | Pharmacy Practice (Annen identifikator: UW Madison)
- ICTR TBCR Pilot Award (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .