Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00761085
First received: September 24, 2008
Last updated: July 14, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: January 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Comparison to standard of care for pain management
Drug: Methadone
Methadone given to compare to standard of care for pain management
Drug: Methadone
Patients are randomized to either receive standard of care or methadone for pain management of acute episode of pain.
Active Comparator: 2
Standard of Care pain management
Drug: Morphine
Standard of care for pain management of acute episode of pain

  Eligibility

Ages Eligible for Study:   7 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00761085     History of Changes
Other Study ID Numbers: 07-0938
Study First Received: September 24, 2008
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014