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

Last updated: June 23, 2005
Sponsor: National Center for Research Resources (NCRR)
Overall Status: Completed

Phase

3

Condition

Pain

Shingles

Chickenpox (Varicella Zoster Infection)

Treatment

N/A

Clinical Study ID

NCT00004390
199/12133
JHUSM-93010802
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 120
Study Start date:
February 01, 1995
Estimated Completion Date:

Study 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.