Study of D-Methadone in Patients With Chronic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Breast Cancer; Head and Neck Cancer; Otorhinolaryngologic Neoplasms; Pancreatic Cancer; Esophageal Cancer; Prostate Cancer; Bladder Cancer; Colon Cancer; Uterine Cancer; CNS Cancer; Eye Cancer
• Intervention / Treatment: Drug: d-Methadone; Drug: D-methadone; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phase I, Group; This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours.	Drug: d-Methadone; 8 subjects to receive 40 mg d-Methadone twice a day
EXPERIMENTAL: Phase II, Group I; patients receiving around the clock opioid therapy-No patients were accrued to this group	Drug: 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.
EXPERIMENTAL: Phase II, Group II; patients not receiving around the clock opioid therapy.No patients were accrued to this group	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Who Reached a Safe Dose	The number of patients who reached a safe and well tolerated dose of d-methadone	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: December 22, 2007
• First Submitted That Met QC Criteria: December 22, 2007
• First Posted (ESTIMATE): January 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 10, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Pain; HEENT cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Eye Diseases; Pain; Neurologic Manifestations; Genital Neoplasms, Female; Uterine Diseases; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Chronic Pain; Uterine Neoplasms; Eye Neoplasms; Otorhinolaryngologic Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone; D-methadone
• Other Study ID Numbers: 01-017