Clinical trial NCT00588640: Study of D-Methadone in Patients With Chronic Pain
Official title: A Phase I/II Study of D-Methadone in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Keywords: Pain
HEENT cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number Who Reached a Safe Dose
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Natalie Moryl, MD
role: PRINCIPAL_INVESTIGATOR
References: