- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032526
Classical Conditioning to Treat Allergic Airway Diseases
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas Medical School
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Contact:
- Gaileen Marshall, MD, PhD
- Phone Number: 713-500-6540
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Masking: Single
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCRR-M01RR02558-0180
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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