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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184496
First received: September 15, 2005
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 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:


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 ]

Enrollment: 42
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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: 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: February 27, 2014
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Analgesics, Opioid/pharmacokinetics
Humans
Methadone/therapeutic use
Neoplasms/complications
pain/drug therapy

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

ClinicalTrials.gov processed this record on September 18, 2014