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Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004390
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
National Institute of Neurological Disorders and Stroke (NINDS)
Johns Hopkins University
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

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 or disease Intervention/treatment Phase
Pain Herpes Zoster Drug: desipramine Drug: methadone Drug: morphine Drug: nortriptyline Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Diagnostically confirmed postherpetic neuralgia for at least 3 months following a segmental herpes zoster eruption

--Prior/Concurrent Therapy--

  • Other: No concurrent monoamine oxidase inhibitors

--Patient Characteristics--

  • Life expectancy: At least 6 months
  • Cardiovascular: No second degree or complete heart blockage No myocardial infarction in the last 3 months
  • Pulmonary: No severe pulmonary disease
  • Other: No history of substance abuse No history of dementia No history of encephalopathy No severe depression that precludes withdrawal from antidepressants Not pregnant No angle-closure glaucoma No AIDS related disease complex No terminal disease with life expectancy of less that 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004390

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Neurological Disorders and Stroke (NINDS)
Johns Hopkins University
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Study Chair: Srinivasa N. Raja Johns Hopkins University

Layout table for additonal information Identifier: NCT00004390    
Other Study ID Numbers: 199/12133
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2000
Keywords provided by Office of Rare Diseases (ORD):
disease-related problem/condition
herpes zoster infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Enzyme Inhibitors