Drug Abuse Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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