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

This study has been completed.

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)

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 Treatment or Intervention Phase
Pain
Herpes Zoster
 Drug: desipramine
 Drug: methadone
 Drug: morphine
 Drug: nortriptyline
Phase III

MedlinePlus related topics:  Pain;   Shingles

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  120

Study start: 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   -   90 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--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

Location Information

Study chairs or principal investigators

Srinivasa N. Raja,  Study Chair,  Johns Hopkins University   

More Information

Study ID Numbers:  199/12133; JHUSM-93010802
Record last reviewed:  February 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004390
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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