Conditioning, the Placebo Effect, and Psoriasis

Psoriasis Clinical Trial

Official title:

Role of Conditioning in the Pharmacotherapy of Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005922
• Other study ID #: R01AR046825
• Secondary ID: R01AR046825NIAMS
• Status: Completed
• Phase: N/A
• First received: June 22, 2000
• Last updated: September 20, 2013
• Start date: August 2000
• Est. completion date: July 2006

Study information

• Verified date: September 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

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:
• Standard pharmacotherapeutic protocol
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California
United States	Adult Dermatology Clinic, Strong Memorial Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Routine and standard quantitative and qualitative assessment of plaque changes and growth		Weekly	No
Primary	Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9		Weekly	No
Secondary	Impacts of Events Scale (IES)		Once - at the initial start of the study	No
Secondary	Psoriasis Life Stress Inventory) (PLSI)		Weekly	No
Secondary	Hassles Scale		Weekly	No
Secondary	Interpersonal Support Evaluation List (ISEL)		Once - at the intial start of the study	No