NCT00580411已完成不适用
A Timeline Study of Alcohol Use and Its Relationship to Insomnia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To characterize the temporal relationship between insomnia and alcohol dependence, alcohol abuse or heavy drinking and determine if this relationship affects the severity of alcohol use.
研究概览
简要总结
This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between the ages of 18-70, may be male or female, and from any ethnic background.
- •Individuals must have the capacity to give IRB-approved study consent.
- •Subjects must at least have a lifetime history of being heavy alcohol drinkers (i.e., drinks approximately 21 alcoholic drinks or more per week). Alternatively, subjects are eligible if they meet criteria for a lifetime history of either alcohol dependence or alcohol abuse. Overall, a subject must meet at least one of these alcohol criteria: a lifetime history of heavy drinking, alcohol abuse or alcohol dependence.
- •Subjects must have a complaint of chronic insomnia, reporting either six or less hours TST, on average at least three times per week.
- •Exclusion Criteria
- •Potential subjects with a lifetime diagnosis of Bipolar Affective Disorder, Schizophrenia, Borderline Personality Disorder, dementia of any type, or epilepsy will not be admitted to the study.
- •Subjects will be excluded with a diagnosis of any other substance dependence syndrome other than alcohol dependence, nicotine dependence, and/or caffeine dependence. However, individuals may have a history of episodic abuse of cannabis, cocaine, sedatives/hypnotics and opiates, amphetamines, and hallucinogens. Also, subjects may be on prescription benzodiazepine or related sedative/hypnotic therapy.
- •Any condition or treatment of a condition that is likely to confound the experimental design or the results will be prohibited by the PI.
排除标准
- 未提供
结局指标
主要结局
To characterize the temporal relationship between insomnia and alcohol dependence, alcohol abuse or heavy drinking and determine if this relationship affects the severity of alcohol use.
时间窗: Visit 1
次要结局
- To assess the utility of 3 sleep disorder instruments: the ISI, the SDQ-8 & the ESS in an inpatient or outpatient population of subjects reporting insomnia with a lifetime history of alcohol dependence, alcohol abuse or heavy drinking.(Visit 1)
研究者
Principal Investigator
National Institute on Drug Abuse (NIDA)
研究点 (1)
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