Insomnia and Drug Relapse Risk
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Sleep Quality, as Measured by Total Sleep Time
研究概览
简要总结
The purposes of this study are:
- to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
- to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
详细描述
Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent methadone maintenance enrollment
- •Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
- •No medical contraindications to trazodone
排除标准
- •Methadone maintenance enrollment not recent
- •No sleep complaints as measured by the PSQI
- •Medical contraindications to trazodone
研究组 & 干预措施
Trazodone
50-150mg (50mg capsules) at bedtime for 90 days
干预措施: Trazodone (Drug)
Placebo
1-3 capsules at bedtime for 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep Quality, as Measured by Total Sleep Time
时间窗: Baseline to 1-month
Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.
次要结局
未报告次要终点
研究者
Michael Stein, MD
Director, General Medicine Research
Butler Hospital
