Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study
February 27, 2014 updated by: Norwegian University of Science and Technology
Cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain relief, will be rotated to Methadone.
We will try to find out what is the best methode to rotate, and the equivalent dosage.
Study Overview
Detailed Description
This study is based on the clinical observation that patients who are not well controlled on morphine or oxycodone may benefit from switching to another opioid, in this case methadone.
Although the mechanism for such switch is not completely understood, evidence indicates that opioids with different chemical structures have different characteristics, not least in relation to new knowledge about genetic variation in opioid receptors.
Another challenge is that there is much uncertainty regarding equianalgesic dose ratios for morphine and methadone.
It seems that the higher the morphine doses, the relatively lower methadone doses are needed to substitute morphine.
Furthermore, there is uncertainty to which switching procedures one should use, the most common ones are "stop and go" and a three days switch.
Finally, it is reported that methadone may increase the QT interval of the ECG, and thus increase the risk for the ventricular arrhythmia Torsade de pointe.
The aim of this randomized, open label, multicenter study is primarily to compare the switching procedures, but it will also provide more knowledge about equianalgesic dose ratios, the effect of methadone on the QT interval, genetical factors that may characterize patients needing opioid switch as well as their response to it, and finally if pharmacokinetic factors plays a role.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Trondheim, Norway, 7006
- St Olavs Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Malignant disease.
- On morphine and in need of opioid rotation. (A patient in need of opioid rotation is defined as having insufficient pain control with or without unacceptable side effects from opioids).
- Able to complete the planned assessment schedules.
- Above 18 years of age.
- If out-patient, the patient lives with someone who can observe him/her.
- Given informed consent according to the ethical guidelines.
Exclusion Criteria:
- Not able to read or write in Norwegian
- The patient has participated in a clinical study 4 weeks prior to inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: methadon
Morphine methadone stop and go switch
|
To methods for switching morphine to methadon.
Stop-and go versus overlap
|
|
Active Comparator: Methadone
Methadon morphine overlap switch
|
To methods for switching morphine to methadon.
Stop-and go versus overlap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The overall aim of the present study is to validate the switching procedure from morphine to methadone for patients with advanced cancer and a short life expectancy. More specifically, we will:
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collect blood samples for present and future genetic analyses in order to explore inter individual variations in methadone and morphine doses based upon possible polymorphisms.
Time Frame: 2 weeks
|
2 weeks
|
|
Compare the QT-intervals on electrocardiograms obtained before and after start with methadone.
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stein Kaasa, MD,PhD Prof., St Olavs University Hospital, Trondheim
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
February 28, 2014
Last Update Submitted That Met QC Criteria
February 27, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPI 03/008
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