Opioid Rotation From Morphine to Methadone in Treatment of Non-Malignant Pain - Full Text View

Sponsor:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00356083

Purpose

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

Condition	Intervention	Phase
Non-Malignant Chronic Pain	Drug: Methadone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

-

Estimated Enrollment:	12
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

addiction
kidney disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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 Brochgrevink, MD PhD	Norwegian University of Science and Technology

More Information

No publications provided

Study ID Numbers:	188-03REK
Study First Received:	July 24, 2006
Last Updated:	July 24, 2006
ClinicalTrials.gov Identifier:	NCT00356083 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010