Study of D-Methadone in Patients With Chronic Pain

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588640
• Other study ID #: 01-017
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 22, 2007
• Last updated: July 24, 2008
• Start date: October 2004
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Chronic Pain
• CNS Cancer
• Colon Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Eye Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Otorhinolaryngologic Neoplasms
• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

Drug:
• d-Methadone
8 subjects to receive 40 mg d-Methadone twice a day
• d-Methadone
8 subjects to receive 80 mg d-Methadone twice a day
• d-Methadone
160 mg d-Methadone twice a day
• D-methadone
After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
• placebo
After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: The objective of this study is to determine a safe and well tolerated dose of d-methadone in patients with chronic pain.		Once dose escalation is complete	Yes
Primary	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.		conclusion of study	Yes
Secondary	The scientific aim of the study is to test safety and efficacy of a possible new non-opioid analgesic.		conclusion of study	Yes

External Links

•   Memorial Sloan-Kettering Cancer Center