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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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:

Outcome Time Frame:

2 weeks

Safety Issue:

No

Principal Investigator

Stein Kaasa, MD,PhD Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St Olavs University Hospital, Trondheim

Authority:

Norway: Norwegian Social Science Data Services

Study ID:

OPI 03/008

NCT ID:

NCT00184496

Start Date:

August 2004

Completion Date:

September 2009

Related Keywords:

  • Cancer
  • Analgesics, Opioid/pharmacokinetics
  • Humans
  • Methdaone/theraputic use
  • Neoplasms/complications
  • pain/drugtherapy

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