Methadone Versus Morphine for Cancer-Related Pain

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Methadone; Morphine

Criteria

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