ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Conditioning, the Placebo Effect, and Psoriasis

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Psoriasis   

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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:   Role of Conditioning in the Pharmacotherapy of Psoriasis

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
A: Experimental
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.
B: Experimental
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.
C: Experimental
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.

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

Investigators
Principal Investigator:     Robert Ader, PhD     University of Rochester School of Medicine and Dentistry    
  More Information


Publications:

Responsible Party:   University of Rochester School of Medicine and Dentistry ( Robert Ader, Ph.D. )
Study ID Numbers:   R01 AR46825, NIAMS-051
First Received:   June 22, 2000
Last Updated:   April 11, 2008
ClinicalTrials.gov Identifier:   NCT00005922
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

Study placed in the following topic categories:
Triamcinolone Acetonide
Skin Diseases
Psoriasis
Triamcinolone
Triamcinolone diacetate
Skin Diseases, Papulosquamous
Triamcinolone hexacetonide

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers