Methadone Versus Morphine for Cancer-Related Pain

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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