Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505583
Recruitment Status : Withdrawn
First Posted : July 23, 2007
Last Update Posted : July 25, 2011
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Condition or disease Intervention/treatment Phase
Methadone-maintenance Subjects Drug: MOA-728 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance
Study Start Date : July 2007
Estimated Primary Completion Date : December 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone
U.S. FDA Resources

Primary Outcome Measures :
  1. To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  1. Healthy men or women, aged 18 to 65 years.
  2. History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.


  1. History or active presence of clinically important medical disease.
  2. Allergy to opioids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505583

United States, Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.

Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00505583     History of Changes
Other Study ID Numbers: 3200A3-1110
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents