Study of D-Methadone in Patients With Chronic Pain

NCT00588640 | Completed Phase 1 Results

• 1 other identifier: 01-017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pain; HEENT cancer

Outcome Measures

Primary Outcomes (1)

• Number Who Reached a Safe Dose

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

  2 years

Study Arms (3)

Phase I, Group

EXPERIMENTAL

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

Phase II, Group I

EXPERIMENTAL

patients receiving around the clock opioid therapy-No patients were accrued to this group

Drug: D-methadone

Phase II, Group II

EXPERIMENTAL

patients not receiving around the clock opioid therapy.No patients were accrued to this group

Drug: placebo

Interventions

D-methadone DRUG

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

Phase I, Group

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.

Phase II, Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I and Phase II portions of the study:
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Pain; Urinary Bladder Neoplasms; Breast Neoplasms; Central Nervous System Neoplasms; Colonic Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms; Uterine Neoplasms; Head and Neck Neoplasms; Eye Neoplasms; Otorhinolaryngologic Neoplasms

Interventions

D-methadone

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Natalia Moryl
• Organization: Memorial Sloan Kettering Cancer Center

moryln@mskcc.org

646-888-2681

Study Officials

• Natalie Moryl, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 8, 2008
• Study Start: October 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 10, 2016
• Results First Posted: August 10, 2016

Record last verified: 2016-06

Locations

US (1)