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Classical Conditioning to Treat Allergic Airway Diseases

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ClinicalTrials.gov Identifier: NCT00032526
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : March 26, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:

Most clinicians who care for patients with inflammatory airway diseases such as allergic rhinitis and asthma are aware of the negative effects of certain sights, sounds and smells that can precipitate clinical exacerbations in certain susceptible patients. This is thought to be due to subconscious associations between these observable stimuli paired and actual exposure to allergens that induce clinical symptoms. The severity and duration of these symptoms are typically related to levels of anxiety and/or depression in affected patients. Classical conditioning of the immune response has been described in many animal and some human studies in association with administration of immunosuppressive drugs. In successfully conditioned individuals, subsequent exposure to the conditioning stimulus alone produces immunosuppressive changes similar to those caused by the drugs themselves. Since disease exacerbating conditioning appears to be prevalent in allergic patients, these conditions make an excellent human model for understanding the relationships between classical conditioning, psychological stress (particularly anxiety and depression) and immune regulation. Thus this proposal will seek to examine the hypothesis that antiinflammatory effects of pharmacotherapeutic agents can be classically conditioned and are clinically effective due to changes in immunoregulatory imbalances known to occur in patients with allergic airway diseases. The effectiveness of this therapeutic approach will be significantly affected by levels of psychological stress and individual suggestibility. This will be investigated with the following Specific Aims: (1). Determine the relative effectiveness of classical conditioning by a novel gustatory stimulus paired with immunosuppressive doses of corticosteroid on in vivo and in vitro immune responses (allergen - specific vs. general) of patients before, during and after classical conditioning correlated with level of clinical response; (2) Determine the role of neuroendocrine mechanisms (particularly catecholamines) on the inducibility and duration of the conditioned immune responses; and (3) Investigate the influence of psychological stress levels (including anxiety and depression) and/or suggestibility on baseline immune changes, success and duration of the classical conditioning.

These data will help define parameters for classical conditioning in humans, establish a model to investigate mechanisms and serve as the basis for development of future interventional protocols for severe inflammatory diseases involving classical conditioning.


Condition or disease Intervention/treatment Phase
Allergic Airway Disease Drug: Corticosteroids Behavioral: Classical conditioning to corticosteroid Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Classical Conditioning to Treat Allergic Airway Diseases




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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Current history of allergic airway disease confirmed by positive skin tests. Included will be only those who have never tasted licorice or do not like the taste of licorice.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032526


Locations
United States, Texas
University of Texas Medical School Recruiting
Houston, Texas, United States, 77030
Contact: Gaileen Marshall, MD, PhD    713-500-6540      
Sponsors and Collaborators
National Center for Research Resources (NCRR)

ClinicalTrials.gov Identifier: NCT00032526     History of Changes
Other Study ID Numbers: NCRR-M01RR02558-0180
First Posted: March 26, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003