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A Phase I/II Study of D-Methadone in Patients With Chronic Pain

Phase 1/Phase 2
18 Years
Not Enrolling
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

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Trial Information

A Phase I/II Study of D-Methadone in Patients With Chronic Pain

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Phase I: The objective of this study is to determine a safe and well tolerated dose of d-methadone in patients with chronic pain.

Outcome Time Frame:

Once dose escalation is complete

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

July 2008

Related Keywords:

  • 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
  • Pain
  • HEENT cancer
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Eye Neoplasms
  • Head and Neck Neoplasms
  • Otorhinolaryngologic Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Uterine Neoplasms
  • Central Nervous System Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021