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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 1, 2008 | ||||
| Last Updated Date | January 23, 2009 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | December 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary objective of this study was to determine whether a non-sedating drug with hypnotic properties (TAK-375) has abuse potential in abusers/misusers of hypnotic or anxiolytic drugs. [ Time Frame: 7 to 8 Days ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00671632 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Subjective, reinforcing, behavioral, and cognitive effects as measured by Subject and Observer Rated Questionnaires. [ Time Frame: 7 to 8 days ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | The purpose of this study is to determine the relative abuse potential of ramelteon compared to triazolam in subjects with a history of drug abuse. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Drug Abuse | ||||
| Intervention ICMJE | Drug: Ramelteon, triazolam, and placebo (56 possible combinations total) | ||||
| Study Arms / Comparison Groups | Experimental: Ramelteon, triazolam, and placebo (56 possible combinations total) | ||||
| Publications * | Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006 Oct;63(10):1149-57. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 14 | ||||
| Completion Date | December 2003 | ||||
| Primary Completion Date | December 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00671632 | ||||
| Responsible Party | Sr. VP, Clinical Science, Takeda Global Research & Development Center | ||||
| Study ID Numbers ICMJE | 01-02-TL-375-015 | ||||
| Study Sponsor ICMJE | Takeda Global Research & Development Center, Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Takeda Global Research & Development Center, Inc. | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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