Study of D-Methadone in Patients With Chronic Pain

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00588640

Run by

Memorial Sloan Kettering Cancer Center

People needed

10

Starts

2004-10-01

Expected to finish

2008-07-01

Last updated by the study team

2016-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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