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

NCT00671632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-02-28

No results posted yet for this study

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

Interventions

DRUG

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

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.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2003-12-31
Completion
2003-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671632 on ClinicalTrials.gov