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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00005922 |
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.
Condition | Intervention |
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Psoriasis |
Behavioral: Partial schedule of pharmacotherapeutic reinforcement Drug: Dose control for Arm B Other: Standard pharmacotherapeutic protocol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Role of Conditioning in the Pharmacotherapy of Psoriasis |
Enrollment: | 138 |
Study Start Date: | August 2000 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
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Other: Standard pharmacotherapeutic protocol
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
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B: Experimental
Participants will receive 100% of the dose of the medication on a partial reinforcement schedule (25% or 50%) as received during the baseline (maintenance) period
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Behavioral: Partial schedule of pharmacotherapeutic reinforcement
Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.
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C: Experimental
Participants will receive 25% or 50% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
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Drug: Dose control for Arm B
Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94305 | |
United States, New York | |
Adult Dermatology Clinic, Strong Memorial Hospital | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Robert Ader, PhD | University of Rochester School of Medicine and Dentistry |
Responsible Party: | University of Rochester School of Medicine and Dentistry ( Robert Ader, Ph.D. ) |
Study ID Numbers: | R01 AR46825, NIAMS-051 |
Study First Received: | June 22, 2000 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00005922 History of Changes |
Health Authority: | United States: Federal Government |
Conditioning Corticosteroid Lesions Pharmacotherapy |
Placebo effect Psoriasis Psychoneuroimmunology |
Anti-Inflammatory Agents Immunologic Factors Skin Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Triamcinolone diacetate Glucocorticoids |
Hormones Immunosuppressive Agents Triamcinolone hexacetonide Triamcinolone Acetonide Psoriasis Triamcinolone Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Skin Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Triamcinolone diacetate Immunosuppressive Agents |
Glucocorticoids Hormones Pharmacologic Actions Triamcinolone hexacetonide Triamcinolone Acetonide Psoriasis Therapeutic Uses Triamcinolone Skin Diseases, Papulosquamous |