Conditioning, the Placebo Effect, and Psoriasis

Role of Conditioning in the Pharmacotherapy of Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Standard pharmacotherapeutic protocol; Behavioral: Partial schedule of pharmacotherapeutic reinforcement; Drug: Dose control for Arm B

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Aristocort A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Impacts of Events Scale (IES)	Once - at the initial start of the study
Psoriasis Life Stress Inventory) (PLSI)	Weekly
Hassles Scale	Weekly
Interpersonal Support Evaluation List (ISEL)	Once - at the intial start of the study

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Robert Ader, PhD, University of Rochester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: June 22, 2000
• First Submitted That Met QC Criteria: June 22, 2000
• First Posted (Estimate): June 23, 2000

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 20, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Psoriasis; Corticosteroid; Pharmacotherapy; Placebo effect; Lesions; Psychoneuroimmunology; Conditioning
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: R01AR046825 (U.S. NIH Grant/Contract); NIAMS-051