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Conditioning, the Placebo Effect, and Psoriasis

Role of Conditioning in the Pharmacotherapy of Psoriasis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005922
Enrollment
138
Registered
2000-06-23
Start date
2000-08-31
Completion date
2006-07-31
Last updated
2013-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Conditioning, Corticosteroid, Lesions, Pharmacotherapy, Placebo effect, Psoriasis, Psychoneuroimmunology

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.

Interventions

BEHAVIORALPartial 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.

DRUGDose 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.

OTHERStandard pharmacotherapeutic protocol

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

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Routine and standard quantitative and qualitative assessment of plaque changes and growthWeekly
Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9Weekly

Secondary

MeasureTime frame
Impacts of Events Scale (IES)Once - at the initial start of the study
Psoriasis Life Stress Inventory) (PLSI)Weekly
Hassles ScaleWeekly
Interpersonal Support Evaluation List (ISEL)Once - at the intial start of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026