Clinical trial NCT00588640 (phase 1/phase 2, status: completed)
Conditions: pain, bladder cancer, breast cancer, cns cancer, colon cancer, esophageal cancer, pancreatic cancer, prostate cancer, uterine cancer, head and neck cancer, eye cancer, otorhinolaryngologic neoplasms
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10, C25.3, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C57.4, D28.2, C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: d-methadone, d-methadone, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

        Phase I and Phase II portions of the study:

          -  18 years of age or older

          -  Chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical
             scale from 0-10 during the 24 hours prior to study entry.

          -  Give informed consent to participate in this study.

          -  Karnofsky Performance Score (KPS) >= to 80

          -  Negative urine pregnancy test, verified by the study nurse, at study entry (for women
             of child-bearing potential). Patients must also use a medically approved contraceptive
             method during the study period.

        Phase I only:

          -  Responsible companion living with patient during study.

        Phase II only:

          -  Group 1 -- Patients must be taking chronic opioid therapy (long acting morphine, long
             acting oxycodone, transdermal fentanyl) at a stable dose for a minimum of four days.
             The dose of as needed short acting opioid does not need to be stable.

          -  Group 2 -- Patients must not be receiving opioids and must have cancer related
             neuropathic pain secondary to post-chemotherapy peripheral neuropathy, post-radiation
             and/or post surgical plexopathy, radiculopathy or neuropathy, or post- herpetic
             neuralgia.

        Exclusion Criteria:

        Phase I and Phase II:

          -  Known hypersensitivity to methadone

          -  Patient taking methadone or with a history of methadone treatment within one month of
             study enrollment.

          -  Patient that requires changes in the dose of one of the following medications within 2
             weeks of study enrollment:

               -  Abacavir,

               -  Benzodiazepines,

               -  Carbamazepine,

               -  Efavirenz,

               -  Fluconazole,

               -  Fluvoxamine,

               -  FOS amprenavir,

               -  Fosphenytoin,

               -  Naltrexone,

               -  Nelfinavir,

               -  Nevirapine,

               -  Phenytoin,

               -  Rifampin,

               -  Rifapentine,

               -  Risperidone,

               -  Ritonavir,

               -  St. John's Wort,

               -  Zidovudine

          -  Hepatic function tests (SGOT, alkaline phosphatase, bilirubin) greater than 2 times
             the upper limit of normal or creatinine greater than 1.4 within 30 days of study
             entry.

          -  Neurologic or psychiatric disease sufficient, in the investigator's opinion, to
             compromise data collection.

          -  Women who are pregnant or nursing.

          -  Women of childbearing potential who do not agree to use a medically recognized method
             of contraception during the study period.