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Study of D-Methadone in Patients With Chronic Pain

CompletedPhase 1, Phase 2NCT00588640
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Phase I/II Study of D-Methadone in Patients With Chronic Pain
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
Interventions
Sponsor
Memorial Sloan Kettering Cancer Center
Start date
2004-10
Primary completion
2008-07
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00588640