Pain Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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