Methadone Versus Morphine for Cancer-Related Pain

Stopped early · Phase 2

Conditions studied: Neoplasms, Pain

In brief

The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.

Key facts

Study ID

NCT00573937

Run by

Mayo Clinic

People needed

1

Starts

2007-08-01

Expected to finish

2009-04-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a telephone
• Age: patient must be 18 years or older and less than 70 years of age
• Life expectancy of 3 months or greater
• No prior use of step-3 opioids (step 2 opioids are allowed)
• Provision of informed consent
• Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
• Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
• Moderate to severe cancer related pain that requires the use of step-3 opioids
• Normal renal function
• There will be no exclusionary criteria based on Karnofsky score
• Must live no more than 1 hour away from clinic
• Patient must have pain severity of 5-7/10 on a 0-10 pain scale

You may not qualify if…

• Nursing home patients
• Obvious cognitive dysfunction
• Intractable nausea or vomiting
• A true allergy or intolerance to opioids
• Unstable renal function
• Undergoing therapeutic procedures likely to influence pain during the study period
• Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
• Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
• History of drug seeking behavior
• Respiratory compromise
• Treatment with bisphosphonates within the last month
• Use of MAO inhibitors
• Drugs that interfere with CYP34A or CYP2D6
• Drugs that interfere with morphine metabolism
• Retroviral therapies
• Active radiation or antineoplastic therapies
• Hepatic dysfunction
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
• Study will exclude women who are pregnant and/or nursing
• Women who are of child bearing potential must have a negative urine pregnancy test
• Patients with a recent substance abuse history will be excluded
• Patients with major depression will be excluded

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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