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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR046825 | U.S. NIH Grant/Contract | View source | |
| NIAMS-051 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial schedule of pharmacotherapeutic reinforcement | Behavioral | 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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| Measure | Description | Time Frame |
|---|---|---|
| Routine and standard quantitative and qualitative assessment of plaque changes and growth | Weekly | |
| Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9 | Weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Impacts of Events Scale (IES) | Once - at the initial start of the study | |
| Psoriasis Life Stress Inventory) (PLSI) | Weekly | |
| Hassles Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Ader, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| Adult Dermatology Clinic, Strong Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1162023 | Background | Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007. | |
| 7815892 | Background | Ader R, Cohen N, Felten D. Psychoneuroimmunology: interactions between the nervous system and the immune system. Lancet. 1995 Jan 14;345(8942):99-103. doi: 10.1016/s0140-6736(95)90066-7. No abstract available. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dose control for Arm B | Drug | 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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| Standard pharmacotherapeutic protocol | Other | Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks. |
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| Weekly |
| Interpersonal Support Evaluation List (ISEL) | Once - at the intial start of the study |
| Rochester |
| New York |
| 14642 |
| United States |
| 9081556 | Background | Giang DW, Goodman AD, Schiffer RB, Mattson DH, Petrie M, Cohen N, Ader R. Conditioning of cyclophosphamide-induced leukopenia in humans. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):194-201. doi: 10.1176/jnp.8.2.194. |
| Background | Ader R. "The role of conditioning in pharmacotherapy." In The placebo effect: An interdisciplinary exploration, edited by A. Harrington, 138-165. Cambridge: Harvard University Press, 1997. |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |