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临床试验/NCT00253890
NCT00253890已完成3 期

Insomnia and Drug Relapse Risk

Butler Hospital1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

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:

  1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
  2. 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

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

Active Comparator

50-150mg (50mg capsules) at bedtime for 90 days

干预措施: Trazodone (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Stein, MD

Director, General Medicine Research

Butler Hospital

研究点 (1)

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