Conditioning, the Placebo Effect, and Psoriasis - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00005922

Purpose

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.

Condition	Intervention
Psoriasis	Behavioral: Partial schedule of pharmacotherapeutic reinforcement Drug: Dose control for Arm B Other: Standard pharmacotherapeutic protocol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Role of Conditioning in the Pharmacotherapy of Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Routine and standard quantitative and qualitative assessment of plaque changes and growth [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9 [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Impacts of Events Scale (IES) [ Time Frame: Once - at the initial start of the study ] [ Designated as safety issue: No ]
Psoriasis Life Stress Inventory) (PLSI) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Hassles Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Interpersonal Support Evaluation List (ISEL) [ Time Frame: Once - at the intial start of the study ] [ Designated as safety issue: No ]

Enrollment:	138
Study Start Date:	August 2000
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 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
Experimental: 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	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
Experimental: 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.	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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005922

Locations

United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, New York
Adult Dermatology Clinic, Strong Memorial Hospital
Rochester, New York, United States, 14642

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:

Robert Ader, PhD

University of Rochester School of Medicine and Dentistry

More Information

Publications:

Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40.

Ader R, Cohen N, Felten D. Psychoneuroimmunology: interactions between the nervous system and the immune system. Lancet. 1995 Jan 14;345(8942):99-103. Review. 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.

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.

Responsible Party:	Robert Ader, Ph.D., University of Rochester School of Medicine and Dentistry
ClinicalTrials.gov Identifier:	NCT00005922 History of Changes
Other Study ID Numbers:	R01 AR46825, NIAMS-051
Study First Received:	June 22, 2000
Last Updated:	April 11, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Conditioning
Corticosteroid
Lesions
Pharmacotherapy

Placebo effect
Psoriasis
Psychoneuroimmunology

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012