Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- response to a pain stimulus
研究概览
简要总结
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
response to a pain stimulus
时间窗: given during study day
Exposure to cold water, followed by exposure to warm water
次要结局
- medication impact , opioid adjective checklist(Study day visit (9-10 hours long))
- Pupil size(Study day visit (9-10 hours long))
- functional measure of balance modified berg balance test(Screening visit (3 hours long) and study day visit (9-10 hours long))
- verbal memory performance on list learning task(Study day visit (9-10 hours long))
研究者
Monique Cherrier
Associate Professor, School of Medicine: Psychiatry And Behavioral Sciences
University of Washington