Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study - Full Text View

Sponsor:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00184496

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer

Drug Information available for: Methadone Methadone hydrochloride

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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
methadon: Active Comparator Morphine metahadone stop and go switch	Drug: Methadone To methods for switching morphien to methadon. Stop-and go versus overlap
Methadone: Active Comparator 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	Recruiting
Trondheim, Norway, 7006
Contact: Stein Kaasa, MD, PhD +47 73867251 stein.kaasa@ntnu.no
Contact: Ola Dale, MD, PhD +47 73598849 ola.dale@ntnu.no

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:	Norwegian University of Science and Technology ( Paal Klepstad, Assosiate professor )
Study ID Numbers:	OPI 03/008
Study First Received:	September 15, 2005
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00184496 History of Changes
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:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010