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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
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-malignant Chronic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 24, 2006
    Last Updated
    July 28, 2016
    Sponsor
    Norwegian University of Science and Technology
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    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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