Clinical trial · Interventional
Methadone Versus Morphine for Cancer-Related Pain
Methadone Versus Morphine for Moderate to Severe Cancer-Related Pain: A Double-Blind Randomized Parallel Group Study
NCT00573937CI-TRIAL-00021005terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methadone | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Methadone
- description
- Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
- interventionNames
- Drug: Methadone
- type
- ACTIVE_COMPARATOR
- label
- Morphine
- description
- Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
- interventionNames
- Drug: Morphine
Primary outcomes (1)
- measure
- Change in Numeric Pain Scale Score
- timeFrame
- Baseline, Week 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Must have a telephone * Age: patient must be 18 years or older and less than 70 years of age * Life expectancy of 3 months or greater * No prior use of step-3 opioids (step 2 opioids are allowed) * Provision of informed consent * Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status) * Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain * Moderate to severe cancer related pain that requires the use of step-3 opioids * Normal renal function * There will be no exclusionary criteria based on Karnofsky score * Must live no more than 1 hour away from clinic * Patient must have pain severity of 5-7/10 on a 0-10 pain scale Exclusion Criteria: * Nursing home patients * Obvious cognitive dysfunction * Intractable nausea or vomiting * A true allergy or intolerance to opioids * Unstable renal function * Undergoing therapeutic procedures likely to influence pain during the study period * Gastrointestinal pathology or surgery that influences absorption of morphine or methadone * Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days * History of drug seeking behavior * Respiratory compromise * Treatment with bisphosphonates within the last month * Use of MAO inhibitors * Drugs that interfere with CYP34A or CYP2D6 * Drugs that interfere with morphine metabolism * Retroviral therapies * Active radiation or antineoplastic therapies * Hepatic dysfunction * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study * Study will exclude women who are pregnant and/or nursing * Women who are of child bearing potential must have a negative urine pregnancy test * Patients with a recent substance abuse history will be excluded * Patients with major depression will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.