Psoriasis Clinical Trial
Official title:
Role of Conditioning in the Pharmacotherapy of Psoriasis
This study uses the psychological principle known as classical conditioning to try to improve the standard treatment of psoriasis. Classical conditioning is a process of behavioral modification in which a person learns to connect a certain response-in this case, improvement of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream. The goal of this study is to show that people with psoriasis who are maintained on corticosteroid cream part of the time and an inactive (placebo) cream at other times show a lower incidence of relapse and a reduced severity of psoriasis that patients treated with that same (reduced) amount of medication administered all the time.
The lack of scientific attention devoted to the placebo effect as a phenomenon in its own
right probably reflects the paucity of theoretical positions within which to organize the
existing data and design new research. This research addresses the clinical significance of
behavior-immune system interactions.
This study will capitalize on conditioned immunosuppressive responses to reduce the
cumulative amount of corticosteroid medication used in the treatment of psoriasis. We will
continue to treat patients with steroid, but will shift experimental patients from their
current schedule of continuous reinforcement (active drug whenever medication is applied) to
a partial schedule of reinforcement (active drug a percentage of the time and placebo alone
at other times). To equate amount of medication, we will treat another group of patients
with a reduced dose of steroid in a standard treatment regimen (continuous schedule of
reinforcement).
We hypothesize that, holding cumulative dose constant, a partial schedule of reinforcement
will enable patients to be maintained on lower cumulative amounts of corticosteroid than
patients treated under a continuous schedule of active drug. This is the first attempt to
adopt conditioning principles and use schedules of reinforcement to design regimens of drug
therapy. If proven effective, this new approach to pharmacotherapy and placebo effects is
likely to stimulate new interdisciplinary research in neuropharmacology and behavioral
pharmacology for the treatment of autoimmune disorders and a variety of other chronic
diseases.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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