Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2000-08-31
2006-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
Standard pharmacotherapeutic protocol
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
B
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
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.
C
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.
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.
Interventions
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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.
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.
Standard pharmacotherapeutic protocol
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be in good health (as determined by prescreening examination).
* Patients must not be using systemic treatment (for example, oral medications) or intralesional, UV, or topical therapies except bland emollients for at least 2 weeks before the start date of the study.
* Patients must have chronic, stable plaque psoriasis with a score of greater than or equal to 7 on a routine 9-point Severity Index.
Exclusion Criteria
* Pregnant or sexually active women who do not use contraceptives.
* Patients who cannot be monitored regularly.
* History of allergy to corticosteroid or other study ointment components.
* Patients who have more than 10 percent of body surface area covered by psoriatic lesions.
18 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Rochester
OTHER
Responsible Party
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University of Rochester School of Medicine and Dentistry
Principal Investigators
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Robert Ader, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Stanford University
Palo Alto, California, United States
Adult Dermatology Clinic, Strong Memorial Hospital
Rochester, New York, United States
Countries
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References
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Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
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.
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.
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.
Other Identifiers
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