A Randomized, Single Center, Double-Blind, Multiple-Dose, Placebo-Controlled, Crossover, Double-Dummy Study of The Acute Behavioral and Subjective Effects of Ramelteon in Subjects With a History of Polydrug Abuse.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration.
研究概览
简要总结
The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.
详细描述
Insomnia is characterized by a complaint of either difficulties initiating and maintaining sleep, or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Participation in this study is anticipated to be about 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ramelteon, triazolam, and placebo (56 poss. combinations)
Ramelteon, triazolam, and placebo (56 possible combinations total)
干预措施: Ramelteon, triazolam, and placebo (56 possible combinations total) (Drug)
结局指标
主要结局
Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration.
时间窗: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
次要结局
- Balance task.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Digit Symbol Substitution Task.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Circular lights task.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Neuropsychometric Testing(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Adverse Events(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Laboratory Test Results(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Vital Signs(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Electrocardiograms(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Physical Examination Findings.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Next Day Questionnaire.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Addiction Research Center Inventory.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Drug Effect Questionnaire.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Subjective Effects Questionnaire.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Pharmacologic Class Questionnaire.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Drug Versus Money Multiple Choice Procedure.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Observer Rated Questionnaire.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Word Recall/Recognition Task.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)
- Enter and Recall Task.(Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit)