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Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse
This study has been completed.
Study NCT00671632   Information provided by Takeda Global Research & Development Center, Inc.
First Received: May 1, 2008   Last Updated: January 23, 2009   History of Changes

May 1, 2008
January 23, 2009
June 2003
December 2003   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00671632 on ClinicalTrials.gov Archive Site
  • Next Day Questionnaire. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Addiction Research Center Inventory. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Drug Effect Questionnaire. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Subjective Effects Questionnaire. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Pharmacologic Class Questionnaire. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Drug Versus Money Multiple Choice Procedure. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Observer Rated Questionnaire. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Word Recall/Recognition Task. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Enter and Recall Task. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Balance task. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Task. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Circular lights task. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Neuropsychometric Testing [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: Yes ]
  • Laboratory Test Results [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: Yes ]
  • Physical Examination Findings. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit ] [ Designated as safety issue: Yes ]
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 ]
 
Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse
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 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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Drug Abuse
Drug: Ramelteon, triazolam, and placebo (56 possible combinations total)
Experimental: Ramelteon, triazolam, and placebo (56 possible combinations total)
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
14
December 2003
December 2003   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Must be in good health as determined by a physician (ie, via medical history and physical examination).
  • Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
  • Must have a history of substance abuse or dependence, on a commonly abuse recreational psychoactive drug (e.g., benzodiazepines, cocaine, opiates, cannabinoids).
  • Must have a negative urine sample for substances of abuse and a negative breathalyzer test before the first dose of study medication is administered.
  • Must be free of any signs/symptoms of withdrawal from substances after admittance to the research unit and prior to the first dose of study medication.
  • Must report liking for study medication given on Day -2 and liking must be of greater magnitude that than the liking for study medication given on Day -1.

Exclusion Criteria

  • Known hypersensitivity to ramelteon or related compounds including melatonin.
  • Known hypersensitivity to benzodiazepines or related compounds.
  • Current diagnosis of any type of physical drug dependence other than nicotine or caffeine.
  • Positive HBsAg are excluded.
  • Positive human immunodeficiency virus antibody at screening.
  • Diastolic blood pressure greater than 90 mm Hg or a systolic pressure of greater than 140 mm Hg at screening.
  • Previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
  • Body weight is less than 99 or greater than 264 pounds. Subjects that are morbidly obese as defined by greater than 2 times ideal body weight
  • Significant urine concentration of any drug that could interfere with the study.
  • Clinically significant abnormal finding on physical examination or electrocardiogram. Subjects with a clinically significant illness in the past 30 days.
  • Current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised diagnosis of a serious psychiatric condition (e.g. Schizophrenia, Major Depression).
  • Currently is participating in another investigational study or has participated in an investigational study within the past 30 days.
  • Any other serious disease or condition at screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00671632
Sr. VP, Clinical Science, Takeda Global Research & Development Center
01-02-TL-375-015
Takeda Global Research & Development Center, Inc.
 
Study Director: VP Clinical Science Takeda Global Research & Development Center, Inc.
Takeda Global Research & Development Center, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP