Methadone Versus Morphine for Cancer-Related Pain
Condition: Neoplasms; Pain
MeSH terms: Cancer Pain
Intervention: Methadone; Morphine
Intervention description: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.; Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Neoplasms; Pain; Methadone; Morphine

Summary:

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

Eligibility 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