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

This study has been completed.
Sponsor:
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184496
First received: September 15, 2005
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

Cancerpatients 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 eqvivalent dosage.


Condition Intervention Phase
Cancer
 Drug: Methadone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Compare the QT-intervals on electrocardiograms obtained before and after start with methadone. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: methadon
Morphine metahadone stop and go switch
 Drug: Methadone
To methods for switching morphien to methadon. Stop-and go versus overlap
Active Comparator: Methadone
Methadon morphine overlap switch
 Drug: Methadone
To methods for switching morphien to methadon. Stop-and go versus overlap

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184496

Locations
Norway
St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Stein Kaasa, MD,PhD Prof. St Olavs University Hospital, Trondheim
  More Information

No publications provided

Responsible Party: Paal Klepstad, Assosiate professor, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184496     History of Changes
Other Study ID Numbers: OPI 03/008
Study First Received: September 15, 2005
Last Updated: July 22, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Analgesics, Opioid/pharmacokinetics
Humans
Methdaone/theraputic use
Neoplasms/complications
pain/drugtherapy

Additional relevant MeSH terms:
Methadone
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013