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Completed

NCT Number: NCT00005922

Conditioning, the Placebo Effect, and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partial schedule of pharmacotherapeutic reinforcement

Behavioral

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

Dose control for Arm B

Drug

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

Standard pharmacotherapeutic protocol

Other

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

Other names: Aristicort A

Primary outcomes

  1. Routine and standard quantitative and qualitative assessment of plaque changes and growth

    Time frame: Weekly

  2. Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9

    Time frame: Weekly

Secondary outcomes

  1. Impacts of Events Scale (IES)

    Time frame: Once - at the initial start of the study

  2. Psoriasis Life Stress Inventory) (PLSI)

    Time frame: Weekly

  3. Hassles Scale

    Time frame: Weekly

  4. Interpersonal Support Evaluation List (ISEL)

    Time frame: Once - at the intial start of the study

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

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

Registry information

Official study title

Role of Conditioning in the Pharmacotherapy of Psoriasis

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Jun 23, 2000
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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