Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain
Primary Purpose
Non-malignant Chronic Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methadone
Sponsored by
About this trial
This is an interventional treatment trial for Non-malignant Chronic Pain
Eligibility Criteria
Inclusion Criteria: 18-70 years of age non-malignant chronic pain morphine use Exclusion Criteria: addiction kidney disorders
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
switch from morphine to methadon
Arm Description
Outcomes
Primary Outcome Measures
pain
Secondary Outcome Measures
Full Information
NCT ID
NCT00356083
First Posted
July 24, 2006
Last Updated
July 28, 2016
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00356083
Brief Title
Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain
Official Title
Opioid Switching From Oral Slow Release Morphine to Oral Methadone May Improve Pain Control in Chronic Non-malignant Pain: a Nine-month Follow-up Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.
Detailed Description
Twelve patients with poor pain control or unacceptable side effects during treatment with morphine were switched to methadone and followed for nine months in this open prospective study. Primary outcomes were patient preference for opioid and pain control while physical, cognitive and role functioning were secondary outcomes. The morphine dose was decreased by 1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period. During switching and a one-week dose titration period, patients were given additional methadone if required. During dose titration one patient experienced sedation requiring naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness or sweating. Seven patients preferred long-term (>nine months) treatment with methadone and reported reduced pain and improved functioning while cognition was not improved. This study brings novel information on the long-term consequences for pain control, health-related quality of life and cognitive functioning with a switch from morphine to methadone in the treatment of chronic non-malignant pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-malignant Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
switch from morphine to methadon
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methadone
Primary Outcome Measure Information:
Title
pain
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years of age
non-malignant chronic pain
morphine use
Exclusion Criteria:
addiction
kidney disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter C. Borchgrevink, PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petter C Borchgrevink, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16877186
Citation
Fredheim OM, Borchgrevink PC, Hegrenaes L, Kaasa S, Dale O, Klepstad P. Opioid switching from morphine to methadone causes a minor but not clinically significant increase in QTc time: A prospective 9-month follow-up study. J Pain Symptom Manage. 2006 Aug;32(2):180-5. doi: 10.1016/j.jpainsymman.2006.02.010.
Results Reference
background
PubMed Identifier
16482756
Citation
Fredheim OM, Kaasa S, Dale O, Klepstad P, Landro NI, Borchgrevink PC. Opioid switching from oral slow release morphine to oral methadone may improve pain control in chronic non-malignant pain: a nine-month follow-up study. Palliat Med. 2006 Jan;20(1):35-41. doi: 10.1191/0269216306pm1099oa.
Results Reference
result
Learn more about this trial
Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain
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