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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) National Institute of Neurological Disorders and Stroke (NINDS) Johns Hopkins University |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004390 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Herpes Zoster |
Drug: desipramine Drug: methadone Drug: morphine Drug: nortriptyline |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Estimated Enrollment: | 120 |
| Study Start Date: | February 1995 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations More Information
| Study ID Numbers: | 199/12133, JHUSM-93010802 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004390 History of Changes |
| Health Authority: | United States: Federal Government |
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disease-related problem/condition herpes zoster infection herpesvirus infection immunologic disorders and infectious disorders |
pain rare disease viral infection |
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Neuralgia, Postherpetic Neurotransmitter Agents Adrenergic Agents Psychotropic Drugs Pain Desipramine Signs and Symptoms Neuromuscular Diseases Nortriptyline Analgesics Antidepressive Agents Analgesics, Opioid Herpes Zoster |
Morphine Neuralgia Rare Diseases Central Nervous System Depressants Narcotics Herpesviridae Infections Antidepressive Agents, Tricyclic Virus Diseases Methadone Peripheral Nervous System Diseases Neurologic Manifestations DNA Virus Infections Peripheral Nervous System Agents |
|
Neuralgia, Postherpetic Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Pain Desipramine Signs and Symptoms Neuromuscular Diseases Sensory System Agents Therapeutic Uses Nortriptyline |
Analgesics Analgesics, Opioid Antidepressive Agents Herpes Zoster Morphine Neuralgia Nervous System Diseases Central Nervous System Depressants Narcotics Enzyme Inhibitors Pharmacologic Actions Herpesviridae Infections Antidepressive Agents, Tricyclic Virus Diseases Peripheral Nervous System Diseases |
