Phase 2 Completed N=10 Randomized Double-blind Treatment

Study of D-Methadone in Patients With Chronic Pain

Postoperative Pain · Bladder Cancer · Breast Cancer · CNS Cancer

Source: ClinicalTrials.gov NCT00588640 ↗

Enrolled (actual)

Serious AEs

22.2%

Results posted

Aug 2016

Primary outcomePrimary: Number Who Reached a Safe Dose — 8 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number Who Reached a Safe Dose	8	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00588640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.