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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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