Risks for Transition From Therapeutic Hypnotic Use to Abuse
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
研究概览
简要总结
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.
详细描述
Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •DSM-5 diagnosis of insomnia
排除标准
- •acute or unstable medical disease,
- •current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
研究组 & 干预措施
Placebo
Intervention: Six months of nightly placebo
干预措施: placebo (Drug)
Zolpidem CR
Intervention: Six months of zolpidem cr 12.5 mg nightly use
干预措施: Zolpidem CR (Drug)
Eszopiclone
Intervention: Six months of eszopiclone 3 mg nightly use
干预措施: Eszopiclone (Drug)
结局指标
主要结局
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
时间窗: total number of capsules chosen in week 1 and week 2 of the discontinuation period
instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary
次要结局
- Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period(mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period)
研究者
Timothy Roehrs, PhD
Senior Bioscientist
Henry Ford Health System