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| ID | Type | Description | Link |
|---|---|---|---|
| JHUSM-93010802 |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Johns Hopkins University | OTHER |
OBJECTIVES: I. Determine whether opioid (morphine) treatment results in better management of pain than treatment with tricyclic antidepressant (nortriptyline).
II. Assess the effects the two treatments have on affective and cognitive functions.
III. Determine whether the presence of psychiatric comorbidity, particularly depression, can predict the outcome of the two treatments.
PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are stratified by the duration of pain (greater than 1 year or no greater than 1 year) and the presence or absence of major depression.
Patients are randomized into 6 treatment order groups. Patients start with nortriptyline, morphine, or placebo, taken orally every day. If patients are unable to tolerate nortriptyline or morphine, they will receive desipramine or methadone instead.
A drug titration period lasting 3 weeks is ensued for administration of the first drug treatment. The goal of this titration period is to gradually increase the dose of the drug to obtain maximal analgesic efficacy. Drug dosage is maintained for a period of 3 weeks. The drug dosage is tapered off and followed by a drug free period of 1 week.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desipramine | Drug | |||
| methadone | Drug | |||
| morphine | Drug | |||
| nortriptyline | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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| Name | Affiliation | Role |
|---|---|---|
| Srinivasa N. Raja | Johns Hopkins University | Study Chair |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| D006566 | Herpesviridae Infections |
| D007154 | Immune System Diseases |
| D003141 | Communicable Diseases |
| D035583 | Rare Diseases |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073618 | Varicella Zoster Virus Infection |
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| ID | Term |
|---|---|
| D003891 | Desipramine |
| D008691 | Methadone |
| D009020 | Morphine |
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D004266 | DNA Virus Infections |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |