Clinical trial NCT00005922: Conditioning, the Placebo Effect, and Psoriasis
Official title: Role of Conditioning in the Pharmacotherapy of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Conditioning
Corticosteroid
Lesions
Pharmacotherapy
Placebo effect
Psoriasis
Psychoneuroimmunology
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2000-06-23
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Psoriasis patients with mild to moderate lesions who are able to attend weekly clinic visits at either the University of Rochester School of Medicine and Dentistry in Rochester, NY, or Stanford University in Palo Alto, CA.
* 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:

* Use of immunosuppressive medication within the past 2 months.
* 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.

Primary outcomes:
measure: Routine and standard quantitative and qualitative assessment of plaque changes and growth
timeFrame: Weekly
measure: Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9
timeFrame: Weekly
Secondary outcomes:
measure: Impacts of Events Scale (IES)
timeFrame: Once - at the initial start of the study
measure: Psoriasis Life Stress Inventory) (PLSI)
timeFrame: Weekly
measure: Hassles Scale
timeFrame: Weekly
measure: Interpersonal Support Evaluation List (ISEL)
timeFrame: Once - at the intial start of the study
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Rochester
country: United States
facility: Adult Dermatology Clinic, Strong Memorial Hospital
state: New York
Study officials:
affiliation: University of Rochester
name: Robert Ader, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
citation: 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.
citation: 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.
citation: 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.