Study of D-Methadone in Patients With Chronic Pain
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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
Intervention: d-Methadone (Drug); d-Methadone (Drug); d-Methadone (Drug); D-methadone (Drug); placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Memorial Sloan Kettering Cancer Center
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.
Clinical Details
Official title: A Phase I/II Study of D-Methadone in Patients With Chronic Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Phase I: The objective of this study is to determine a safe and well tolerated dose of d-methadone in patients with chronic pain.Phase II: The objective of this study is to evaluate the analgesic efficacy of d-methadone in patients taking opioids for cancer related pain and in patients not taking opioids with cancer related neuropathic pain.
Secondary outcome: The scientific aim of the study is to test safety and efficacy of a possible new non-opioid analgesic.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: October 2004
Last updated: July 24, 2008
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