Study of D-Methadone in Patients With Chronic Pain

Phase 1

Completed

• Conditions: Pain; CNS Cancer; Eye Cancer; Otorhinolaryngologic Neoplasms; Bladder Cancer; Esophageal Cancer; Pancreatic Cancer; Breast Cancer; Colon Cancer; Prostate Cancer
• Interventions: Drug: D-methadone; Drug: placebo

• Registration Number: NCT00588640
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2008-01-08
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2015-12-17
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Results First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase I, Group	D-methadone	This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours.
Phase II, Group I	D-methadone	patients receiving around the clock opioid therapy-No patients were accrued to this group
Phase II, Group II	placebo	patients not receiving around the clock opioid therapy.No patients were accrued to this group

Primary Outcome Measures

Name	Time	Method
Number Who Reached a Safe Dose	2 years	The number of patients who reached a safe and well tolerated dose of d-methadone

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States