Alcohol Sensitivity Among Older Adults Who Consume Alcohol
2026年6月3日 更新者:University of Florida
Individual Differences in Alcohol Sensitivity
This is a proof-of-concept study exploring individual differences in sensitivity to alcohol among older healthy current drinkers aged 65 to 80. Participants will complete two sessions during which they will complete questionnaires and laboratory measures of mental abilities and brain activity and receive a beverage that may or may not contain a moderate dose of alcohol.
研究概览
详细说明
As a preliminary, proof-of-concept study, the project is designed to provide information regarding variability in response to a moderate dose of alcohol among healthy men and women who are current drinkers and aged 65 to 80.
It is expected that approximately 75 individuals will complete the study.
Participants complete two laboratory sessions.
Each session will include consuming a beverage that may or may not include alcohol.
If the beverage does include alcohol, the volume will not exceed the amount that a drinker might consume in 1 to 2 drinks.
The outcomes will provide information regarding the how older adults vary in their response to alcohol and explore whether alcohol sensitivity is related to selected measures of cognition.
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
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:Sara Jo Nixon, PhD
- 电话号码:352-294-4920
- 邮箱:sjnixon@ufl.edu
研究联系人备份
- 姓名:Ben Lewis, PhD
- 电话号码:352-294-4920
- 邮箱:benlewis@ufl.edu
学习地点
-
-
Florida
-
Gainesville、Florida、美国、32610
- University of Florida
-
接触:
- Sara Jo Nixon, PhD
- 电话号码:352-294-4920
- 邮箱:sjnixon@ufl.edu
-
接触:
- Ben Lewis, PhD
- 电话号码:35222944920
- 邮箱:benlewis@ufl.edu
-
首席研究员:
- Sara Jo Nixon, PhD
-
-
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
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria
- Alcohol Drinkers who consume alcohol on a regular basis
- No history of significant substance misuse
- at least 12 years of education or GED equivalence Exclusion Criteria
- current Cigarette smoker
- Type 1 Diabetes or uncontrolled Type 2 Diabetes
- Epilepsy
- Neurodegenerative disorder
- Significant psychiatric disorder such as a psychotic disorder, bipolar disorder, current major depression or PTSD
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:非随机化
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Alcohol Condition
Beverage contains an alcohol volume consistent with achieving a sub-intoxicating breath alcohol concentration
|
Described elsewhere
|
|
安慰剂比较:Non-Alcohol Session
Placebo beverage is administered
|
on each of two visits, participants receive either the placebo drink or the drinking containing alcohol
|
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 |
|---|---|---|
|
Alcohol Effects on Psychomotor Skills as reflected in the Trail Making Test (TMT)
大体时间:The placebo and alcohol sessions occur ~ 10-14 days apart.
|
Difference between the number of seconds required to complete the TMT under placebo vs the alcohol condition for each individual
|
The placebo and alcohol sessions occur ~ 10-14 days apart.
|
|
Alcohol Effects on a Working Memory Task requiring Continuous Recognition
大体时间:The placebo and alcohol sessions occur ~ 10-14 days apart.
|
Differences in accuracy in identifying previously seen vs. new items a working memory task under alcohol vs placebo conditions for each individual
|
The placebo and alcohol sessions occur ~ 10-14 days apart.
|
|
Alcohol Effects on Neural Activity Measured from Scalp Electroencephalography
大体时间:The alcohol and placebo sessions occur ~ 10-14 days apart.
|
Differences in neural activity as reflected obtained through non-invasive electroencephalography under alcohol vs placebo conditions for each individual
|
The alcohol and placebo sessions occur ~ 10-14 days apart.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between alcohol sensitivity and standard cognitive assessment
大体时间:The general measure of cognitive abilities is obtained in the first session, prior to the experimental condition. The difference scores are derived by comparing outcomes between alcohol vs placebo sessions which are ~ 10-14 days apart.
|
Correlations between differences under alcohol vs placebo conditions for the psychomotor task, the working memory task, the measure of neural activity and performance on a general measure of cognitive abilities
|
The general measure of cognitive abilities is obtained in the first session, prior to the experimental condition. The difference scores are derived by comparing outcomes between alcohol vs placebo sessions which are ~ 10-14 days apart.
|
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:Ben Lewis, PhD、University of Florida
- 首席研究员:Sara Jo Nixon, PhD、University of Florida
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7月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年6月1日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月9日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Data will be made available through an NIH repository.
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
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.