Study of D-Methadone in Patients With Chronic Pain

NCT ID: NCT00588640

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

d-Methadone

Intervention Type: DRUG

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

Phase II, Group I

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

Group Type: EXPERIMENTAL

D-methadone

Intervention Type: 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

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

Group Type: EXPERIMENTAL

placebo

Intervention Type: 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.

Interventions

d-Methadone

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Moryl, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

01-017

Identifier Type: -

Identifier Source: org_study_id