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Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphine
Methadone
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

7 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnes Jewish Hospital/St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Methadone-Children

Morphine-Children

Methadone-Adults

Morphine-Adults

Arm Description

Methadone comparison to standard of care for pain management

Morphine standard of Care pain management

Methadone comparison to standard of care for pain management

Morphine standard of Care pain management

Outcomes

Primary Outcome Measures

To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
R-Methadone AUC

Secondary Outcome Measures

Pain Relief
Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced

Full Information

First Posted
September 24, 2008
Last Updated
January 8, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00761085
Brief Title
Methadone in Pediatric and Adult Sickle Cell Patients
Acronym
MSCD
Official Title
Methadone in Pediatric and Adult Sickle Cell Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2008 (Actual)
Primary Completion Date
November 7, 2010 (Actual)
Study Completion Date
November 7, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methadone-Children
Arm Type
Active Comparator
Arm Description
Methadone comparison to standard of care for pain management
Arm Title
Morphine-Children
Arm Type
Active Comparator
Arm Description
Morphine standard of Care pain management
Arm Title
Methadone-Adults
Arm Type
Active Comparator
Arm Description
Methadone comparison to standard of care for pain management
Arm Title
Morphine-Adults
Arm Type
Active Comparator
Arm Description
Morphine standard of Care pain management
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Standard of care for pain management of acute episode of pain
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Compare to standard of care for pain management of acute episode of pain
Primary Outcome Measure Information:
Title
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
Description
R-Methadone AUC
Time Frame
96 hr
Secondary Outcome Measure Information:
Title
Pain Relief
Description
Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced
Time Frame
72 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan D Kharasch, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Jewish Hospital/St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27572136
Citation
Horst J, Frei-Jones M, Deych E, Shannon W, Kharasch ED. Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2123-2130. doi: 10.1002/pbc.26207. Epub 2016 Aug 30.
Results Reference
derived

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Methadone in Pediatric and Adult Sickle Cell Patients

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