Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse

Phase 2

Completed

• Conditions: Drug Abuse
• Interventions: Drug: Ramelteon, triazolam, and placebo (56 possible combinations total)

• Registration Number: NCT00671632
• Lead Sponsor: Takeda

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ramelteon, triazolam, and placebo (56 poss. combinations)	Ramelteon, triazolam, and placebo (56 possible combinations total)	Ramelteon, triazolam, and placebo (56 possible combinations total)

Primary Outcome Measures

Name	Time	Method
Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration.	Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit

Secondary Outcome Measures

Name	Time	Method
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