NCT00027053已完成2 期
Trazodone for Sleep Disturbance - Early Alcohol Recovery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Percent days abstinent from alcohol (PDA)
研究概览
简要总结
This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed an alcohol detoxification program.
- •Meets criteria for alcohol dependence.
- •Meets criteria for sleep disturbance.
- •If female of childbearing potential must be using adequate contraception.
- •Has a location to which they will return after the initial research interview and a person they regularly contact.
- •Speaks English sufficiently to understand instructions and assessment.
排除标准
- •Meets criteria for substance dependence for sedative/hypnotic drugs, stimulants, cocaine or opiates, or of organic brain disorder, bipolar disorder, schizophrenia, schizoaffective, schizophreniform, or paranoid disorder, or major depression.
- •Current suicidality.
- •Use of psychotropic, antidepressant, anxiolytic or antidipsogenic medication.
- •Inability or refusal to terminate the use of proerectile agents, herbal medications or sleep medication for the study period.
- •The presence of contraindications to the study medications, including pregnancy/lactation, ischemic heart disease, cardiac arrhythmias, priapism or hypotension.
- •Presence of comorbid medical conditions associated with sleep disturbance including obstructive sleep apnea, poorly controlled diabetes mellitus or emphysema.
- •Evidence of neuropsychological dysfunction.
- •Probation/parole requirements that might interfere with participation in study.
- •Inability to identify at least one contact person.
- •Living on the street after detoxification (homeless persons living in a shelter, halfway house or other residence will not be excluded).
研究组 & 干预措施
Trazodone
Experimental
干预措施: Trazodone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent days abstinent from alcohol (PDA)
时间窗: 12 and 24 weeks
次要结局
- sleep quality(12 and 24 weeks)
- Drinks per drinking day(12 and 24 weeks)
研究者
研究点 (1)
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