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| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2000 | ||||
| Last Updated Date | April 11, 2008 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00005922 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Conditioning, the Placebo Effect, and Psoriasis | ||||
| Official Title ICMJE | Role of Conditioning in the Pharmacotherapy of Psoriasis | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Psoriasis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 138 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005922 | ||||
| Responsible Party | Robert Ader, Ph.D., University of Rochester School of Medicine and Dentistry | ||||
| Study ID Numbers ICMJE | R01 AR46825, NIAMS-051 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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