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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Randomized sequence over eight consecutive days to include the following: Ramelteon 16 mg, tablets, orally, one day only; Ramelteon 80 mg, tablets, orally, one day only; Ramelteon 160 mg, tablets, orally, one day only; Triazolam 0.25 mg, capsules, orally, one day only; Triazolam 0.50 mg, capsules, orally, one day only; Triazolam 0.75 mg, capsules, orally, one day only; Ramelteon placebo-matching tablets, orally, one day only, OR Triazolam placebo-matching capsules, orally, one day only; Additional dose of study medication or placebo, tablets or capsules, orally, one day only.
Unnamed facility
Baltimore, Maryland, United States
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
Next Day Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Addiction Research Center Inventory.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Drug Effect Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Subjective Effects Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Pharmacologic Class Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Drug Versus Money Multiple Choice Procedure.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Observer Rated Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Word Recall/Recognition Task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Enter and Recall Task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Balance task.
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Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Digit Symbol Substitution Task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Circular lights task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Neuropsychometric Testing
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Adverse Events
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Laboratory Test Results
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Vital Signs
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Electrocardiograms
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Physical Examination Findings.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit