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Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184496
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 28, 2014
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Methadone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study
Study Start Date : August 2004
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: methadon
Morphine methadone stop and go switch
Drug: Methadone
To methods for switching morphine to methadon. Stop-and go versus overlap

Active Comparator: Methadone
Methadon morphine overlap switch
Drug: Methadone
To methods for switching morphine to methadon. Stop-and go versus overlap

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. Compare the QT-intervals on electrocardiograms obtained before and after start with methadone. [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00184496

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St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
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Principal Investigator: Stein Kaasa, MD,PhD Prof. St Olavs University Hospital, Trondheim
Publications of Results:
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT00184496    
Other Study ID Numbers: OPI 03/008
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Keywords provided by Norwegian University of Science and Technology:
Analgesics, Opioid/pharmacokinetics
Methadone/therapeutic use
pain/drug therapy
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents