Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics (TAP)
2026年8月5日 更新者: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.
研究概览
详细说明
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).
研究类型
介入性
注册 (估计的)
5
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Heather Barkholtz, PhD
- 电话号码:608-890-1967
- 邮箱:hbarkholtz@wisc.edu
研究联系人备份
- 姓名:Michael Chen, MD
- 邮箱:michael.chen@fammed.wisc.edu
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- University of Wisconsin
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Ethanol Concentration (Cmax)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Score
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Heather Barkholtz, PhD、UW School of Pharmacy
- 首席研究员:Michael Chen, MD、UW School of Medicine and Public Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年8月5日
首先提交符合 QC 标准的
2026年8月5日
首次发布 (实际的)
2026年8月11日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月5日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026-1120
- Protocol Version 7/20/26 (其他标识符:UW Madison)
- Pharmacy | Pharmacy Practice (其他标识符:UW Madison)
- ICTR TBCR Pilot Award (其他标识符:UW Madison)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
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 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.