Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004390
|Study Chair:||Srinivasa N. Raja||Johns Hopkins University|