Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Herpes Zoster
Intervention: desipramine (Drug); methadone (Drug); morphine (Drug); nortriptyline (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Srinivasa N. Raja, Study Chair, Affiliation: Johns Hopkins University
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): 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
Locations and Contacts
Additional Information
Starting date: February 1995
Last updated: June 23, 2005
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