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The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study arm | Experimental | low dose methadone (1-10mg daily) |
|
| control arm | Active Comparator | low dose morphine (1-10 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral methadone | Drug | Oral methadone is the study drug |
| |
| oral morphine |
| Measure | Description | Time Frame |
|---|---|---|
| pain relief | 1) Pain item of the Edmonton Symptom Assessment Scale | 2 months |
| pain relief | Questions 3 to 6 of the Brief Pain Inventory | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". | prevalence and severity of opioid induced side effects | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| pain interference | Brief Pain Inventory: Composite questions 9-A to 9-G | 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alan Edwards Pain Management Unit. Mcgill University Health Centre | Recruiting | Montreal | Quebec | H3G1A4 | Canada |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
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| Drug |
Oral morphine is the active comparator. It is not a placebo intervention |
|
| D053610 |
| Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |