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

Non-malignant Chronic Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356083
• Other study ID #: 188-03REK
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2006
• Last updated: July 28, 2016
• Start date: January 2004
• Est. completion date: March 2005

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years of age

• non-malignant chronic pain

• morphine use

Exclusion Criteria:

• addiction

• kidney disorders

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Non-malignant Chronic Pain

Intervention

Drug:
• Methadone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

References & Publications (2)

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. — View Citation

Fredheim OM, Kaasa S, Dale O, Klepstad P, Landrø 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):35-4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain		9 months	Yes