Conditioning, the Placebo Effect, and Psoriasis
|Psoriasis||Behavioral: Partial schedule of pharmacotherapeutic reinforcement Drug: Dose control for Arm B Other: Standard pharmacotherapeutic protocol|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||Role of Conditioning in the Pharmacotherapy of Psoriasis|
- Routine and standard quantitative and qualitative assessment of plaque changes and growth [ Time Frame: Weekly ]
- Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9 [ Time Frame: Weekly ]
- Impacts of Events Scale (IES) [ Time Frame: Once - at the initial start of the study ]
- Psoriasis Life Stress Inventory) (PLSI) [ Time Frame: Weekly ]
- Hassles Scale [ Time Frame: Weekly ]
- Interpersonal Support Evaluation List (ISEL) [ Time Frame: Once - at the intial start of the study ]
|Study Start Date:||August 2000|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
Other: Standard pharmacotherapeutic protocol
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
Other Name: Aristicort A
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
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.
Other Name: Aristocort A
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.
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.
Other Name: Aristocort A
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005922
|United States, California|
|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|