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

NCT00671632 | Completed Phase 2

• 2 other identifiers: 01-02-TL-375-015U1111-1114-3109
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Abuse

Keywords

Addiction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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

Study Arms (1)

Ramelteon, triazolam, and placebo (56 poss. combinations)

EXPERIMENTAL

Ramelteon, triazolam, and placebo (56 possible combinations total)

Drug: Ramelteon, triazolam, and placebo (56 possible combinations total)

Interventions

Ramelteon, triazolam, and placebo (56 possible combinations total) DRUG

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.

Also known as: Rozerem™, TAK-375

Ramelteon, triazolam, and placebo (56 poss. combinations)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Baltimore, Maryland, United States

Location

Related Publications (1)

• 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. doi: 10.1001/archpsyc.63.10.1149.

  PMID: 17015817 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Interventions

ramelteon; Triazolam

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• VP Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: June 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (1)