NCT00588640CompletedPhase 1
A Phase I/II Study of D-Methadone in Patients With Chronic Pain
Memorial Sloan Kettering Cancer Center1 site in 1 country10 target enrollmentStarted: October 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number Who Reached a Safe Dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: D-methadone (Drug)
Phase II, Group I
Experimental
patients receiving around the clock opioid therapy-No patients were accrued to this group
Intervention: D-methadone (Drug)
Phase II, Group II
Experimental
patients not receiving around the clock opioid therapy.No patients were accrued to this group
Intervention: placebo (Drug)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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