Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics (TAP)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Heather Barkholtz, PhD
- 전화번호: 608-890-1967
- 이메일: hbarkholtz@wisc.edu
연구 연락처 백업
- 이름: Michael Chen, MD
- 이메일: michael.chen@fammed.wisc.edu
연구 장소
-
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum Ethanol Concentration (Cmax)
기간: 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
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Cmax will be determined from visual inspection of the concentration-time plots.
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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
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Time to Maximum Ethanol Concentration (Tmax)
기간: 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
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Tmax will be determined from visual inspection of the concentration-time plots.
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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
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Ethanol Elimination Rate: Blood samples
기간: 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
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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
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Ethanol Elimination Rate: Breath tests
기간: 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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Data derived from breath alcohol test.
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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
기간: prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes
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Data derived from urine samples.
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prior to dosing (-25 minutes), 60 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Biphasic Alcohol Effects Scale (BAES) Score
기간: 5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
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The BAES has 2 subscales: Stimulant scored from 0-70 and Sedative scored from 0-70.
Higher scores indicate higher stimulant or sedative effects.
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5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
|
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Risk Perception and Safety Appraisal (RPSA) Score
기간: 5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
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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.
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5 minutes, 35 minutes, 65 minutes, 95 minutes, 125 minutes, 185 minutes, 245 minutes, 290 minutes, 340 minutes
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Divided Attention Task (DAT)
기간: prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
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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)
기간: prior to dosing (-20 minutes), 10 minutes, 100 minutes, 220 minutes
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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)
기간: 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
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Heather Barkholtz, PhD, UW School of Pharmacy
- 수석 연구원: Michael Chen, MD, UW School of Medicine and Public Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-1120
- Protocol Version 7/20/26 (기타 식별자: UW Madison)
- Pharmacy | Pharmacy Practice (기타 식별자: UW Madison)
- ICTR TBCR Pilot Award (기타 식별자: UW Madison)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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