Study of D-Methadone in Patients With C… | Clinical Trial

Key information

Conditions

Pain Bladder Cancer Breast Cancer Breast Diseases Breast Neoplasms CNS Cancer Central Nervous System Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Eye Cancer Eye Diseases Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

d-Methadone

Drug

8 subjects to receive 40 mg d-Methadone twice a day

Placebo

Drug

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 outcomes

Number Who Reached a Safe Dose

Time frame: 2 years

The number of patients who reached a safe and well tolerated dose of d-methadone

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Jan 8, 2008
Registry last updated: Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed