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

NCT ID: NCT00356083

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-03-31

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.

Conditions

Non-malignant Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

switch from morphine to methadon

Group Type: EXPERIMENTAL

Methadone

Intervention Type: DRUG

Interventions

Methadone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• addiction
• kidney disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petter C. Borchgrevink, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Petter C Borchgrevink, MD PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

References

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.

Reference Type: BACKGROUND

PMID: 16877186 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16482756 (View on PubMed)

Other Identifiers

188-03REK

Identifier Type: -

Identifier Source: org_study_id