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Clinical Trial Record

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Study of D-Methadone in Patients With Chronic Pain

2004-10

2008-07

2008-07

10

Study Overview

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.

N/A

  • 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
  • DRUG: d-Methadone
  • DRUG: D-methadone
  • DRUG: placebo
  • 01-017

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2007-12-22  

2015-12-17  

2016-06-29  

2007-12-22  

2016-06-29  

2016-08-10  

2008-01-08  

2016-08-10  

2016-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
Double

Arms and Interventions

Participant Group/ArmIntervention/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.

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.
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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number Who Reached a Safe DoseThe number of patients who reached a safe and well tolerated dose of d-methadone2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Natalie Moryl, MD, Memorial Sloan Kettering Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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