Study of D-Methadone in Patients With Chronic Pain

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: D-methadone; Methadone

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.