Nortriptyline and Morphine for Postherpetic Neuralgia Management
This phase 3 study aims to evaluate the effectiveness of Nortriptyline and Morphine in managing postherpetic neuralgia, a pain condition that occurs after shingles.
desipramine
+ methadone
+ morphine
Varicella Zoster Virus Infection+13
+ DNA Virus Infections
+ Infections
Treatment Study
Summary
Study start date: February 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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