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New York, New York 10065


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.


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.



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New York, New York 10065
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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