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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184496
• Other study ID #: OPI 03/008
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: February 27, 2014
• Start date: August 2004
• Est. completion date: September 2009

Study information

• Verified date: February 2014
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Methadone
To methods for switching morphine to methadon. Stop-and go versus overlap

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Moksnes K, Dale O, Rosland JH, Paulsen O, Klepstad P, Kaasa S. How to switch from morphine or oxycodone to methadone in cancer patients? a randomised clinical phase II trial. Eur J Cancer. 2011 Nov;47(16):2463-70. doi: 10.1016/j.ejca.2011.06.047. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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:		2 weeks	No
Secondary	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.		2 weeks	No
Secondary	Compare the QT-intervals on electrocardiograms obtained before and after start with methadone.		2 weeks	Yes