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Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

This study is currently recruiting participants.
Verified July 2016 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761085
First Posted: September 26, 2008
Last Update Posted: July 20, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.

Condition Intervention
Sickle Cell Disease Drug: Morphine Drug: Methadone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methadone in Pediatric and Adult Sickle Cell Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine the pharmacokinetics of methadone in children and adults with Sickle Cell disease experiencing a VOE. [ Time Frame: November 2009 ]

Secondary Outcome Measures:
  • Pain [ Time Frame: November 2009 ]

Estimated Enrollment: 54
Study Start Date: January 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone
Methadone comparison to standard of care for pain management
Drug: Methadone
Methadone given to compare to standard of care for pain management
Active Comparator: Morphine
Mophine standard of Care pain management
Drug: Morphine
Standard of care for pain management of acute episode of pain

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than or equal to 7 years and less than or equal to 40 years
  • Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
  • Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
  • Admitted to the inpatient unit for further treatment
  • Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

  • Diagnosis of acute chest syndrome
  • New focal neurologic findings or clinical concern of stroke
  • Aplastic crisis with hemoglobin 2 g/dl below steady-state value
  • Allergy to morphine or methadone
  • Any other medical condition that the attending physician deems to be a contraindication to therapy
  • Liver or renal insufficiency or failure, and congestive heart failure
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00761085


Locations
United States, Missouri
Barnes Jewish Hospital/St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Evan D Kharasch, MD, PhD    314-362-7551    kharasch@wustl.edu   
Contact: Jane Blood, RN    314-747-5531    bloodj@wust.edu   
Principal Investigator: Evan D Kharasch, MD, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Evan D Kharasch, MD, PhD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00761085     History of Changes
Other Study ID Numbers: 201107091
First Submitted: September 24, 2008
First Posted: September 26, 2008
Last Update Posted: July 20, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Morphine
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents