Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users (CAAP)
2021年5月10日 更新者:Monique Cherrier、University of Washington
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
研究概览
详细说明
Potential participants complete a phone screen.
If still found eligible, the participant comes in for 1 screening visit (3 hours long).
Cognitive/problem solving tests, computerized tasks, CPT, questionnaires and functional measures are administered along with a screening blood lab.
If a participant is eligible, he/she comes back for 1 full study day visit (9-10 hours long).
A testing battery (similar to the one done during the screening visit) is completed at baseline and again at three timepoints following medication administration.
Blood draws, vital signs, and pupil measurements are taken throughout the day.
A follow-up phone call is completed within a few days of the full study day visit, during which a questionnaire is given.
研究类型
观察性的
注册 (实际的)
128
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。
学习地点
-
-
Washington
-
Seattle、Washington、美国、98195
- Univ. of Washington Medical Center
-
-
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
35年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
community dwelling participants in the greater Puget Sound region (Seattle and Tacoma) who consume alcohol on a frequent basis
描述
Inclusion Criteria:
- Age of 35 years old or above
- Mild to moderate pain
- alcohol consumption
- willingness to refrain from taking any sort of pain medication 24 hours prior to study visit as well as refraining from taking sedative-hypnotics, antihistamines, benzodiazepines, sleep aids, NSAIDs/opioid pain medications, alcohol, marijuana
- Cigarette smokers must be willing to refrain from smoking during the all day study visit
Exclusion Criteria:
- current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine)
- abstains from alcohol
- unstable angina or CHF; cerebral vascular accident or recurrent TIAs in the prior 6 months, active cancer requiring current treatment, possible or probable dementia or mild cognitive impairment
- Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication
- History of recreational drug use in the past 1 year, excluding marijuana
- New or increased dose (within last 6 months) of CNS-active medications that may alter neurocognitive and/or psychomotor function: MAO inhibitors, neuroleptics, antidepressants, anticonvulsants, benzodiazepines, sleep aids
- Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin
- Known hypersensitivity to oxycodone and other opioids;
- Pregnancy
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
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Study Procedures
Study procedures include a screening visit, a study day visit, and a follow-up phone call.
Oxycodone is administered on the study day.
|
This study is interventional.
Participants are given a single, one time administration of medication 10mg of oxycodone and observed
|
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 |
|---|---|---|
|
response to a pain stimulus
大体时间:given during study day
|
Exposure to cold water, followed by exposure to warm water
|
given during study day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
medication impact , opioid adjective checklist
大体时间:Study day visit (9-10 hours long)
|
adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale
|
Study day visit (9-10 hours long)
|
|
functional measure of balance modified berg balance test
大体时间:Screening visit (3 hours long) and study day visit (9-10 hours long)
|
score on a functional questionnaire (0 - 30)
|
Screening visit (3 hours long) and study day visit (9-10 hours long)
|
|
Pupil size
大体时间:Study day visit (9-10 hours long)
|
measure of pupil diameter in millimeters
|
Study day visit (9-10 hours long)
|
|
verbal memory performance on list learning task
大体时间:Study day visit (9-10 hours long)
|
immediate and delayed recall of a list of words (score of 0 - 45)
|
Study day visit (9-10 hours long)
|
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。
合作者
调查人员
- 首席研究员:Monique M. Cherrier, Ph.D.、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2015年11月1日
初级完成 (实际的)
2019年10月1日
研究完成 (预期的)
2021年9月1日
研究注册日期
首次提交
2016年10月18日
首先提交符合 QC 标准的
2016年10月24日
首次发布 (估计)
2016年10月26日
研究记录更新
最后更新发布 (实际的)
2021年5月13日
上次提交的符合 QC 标准的更新
2021年5月10日
最后验证
2021年5月1日
更多信息
与本研究相关的术语
其他研究编号
- STUDY00001018
- 5R01AG047979 (美国 NIH 拨款/合同)
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
For data obtained at UofW- a de-identified version can be made available upon request for data obtained at VAPSHCS IRB ISO, and PO do not allow the sharing of data, even de-identified data with other investigators- if VA regulations allow data sharing, then the investigators will be allowed to share data
IPD 共享时间框架
upon completion of the study a copy of information will be made available on the open science framework site
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
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.