Clinical trial · Interventional
Study of D-Methadone in Patients With Chronic Pain
A Phase I/II Study of D-Methadone in Patients With Chronic Pain
NCT00588640CI-TRIAL-00023417completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| CNS Cancer | Malignant Central Nervous System Neoplasm | ALIAS | 0.90 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Eye Cancer | Malignant Eye Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Otorhinolaryngologic Neoplasms | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| d-Methadone | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I, Group
- description
- This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours.
- interventionNames
- Drug: d-Methadone
- type
- EXPERIMENTAL
- label
- Phase II, Group I
- description
- patients receiving around the clock opioid therapy-No patients were accrued to this group
- interventionNames
- Drug: D-methadone
- type
- EXPERIMENTAL
- label
- Phase II, Group II
- description
- patients not receiving around the clock opioid therapy.No patients were accrued to this group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.