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Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain

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ClinicalTrials.gov Identifier: NCT00356083
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.

Condition or disease Intervention/treatment Phase
Non-malignant Chronic Pain Drug: Methadone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2004
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: switch from morphine to methadon Drug: Methadone



Primary Outcome Measures :
  1. pain [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 years of age
  • non-malignant chronic pain
  • morphine use

Exclusion Criteria:

  • addiction
  • kidney disorders

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): NCT00356083


Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Petter C. Borchgrevink, PhD MD Norwegian University of Science and Technology
Study Chair: Petter C Borchgrevink, MD PhD Norwegian University of Science and Technology

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00356083     History of Changes
Other Study ID Numbers: 188-03REK
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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