Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation
Chronic Obstructive Pulmonary Disease (COPD), Asthma, Smoking
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- Being continuous tobacco smokers (>10 cigarettes per day) for at least 6 months
- Being unemployed for at least 3 months
- Being diagnosed with Asthma
- Being diagnosed with C.O.P.D.
- Age < 35, for the group of Young Unemployed
- Age >35 years, for the groups of Asthma and C.O.P.D. patients
Exclusion Criteria:
- Diagnosed neurological, mental or psychiatric illness
- Drug-resistance epilepsy
Sites / Locations
- National Association of General Practitioners in Bulgaria
- AAI Scientific Cultural Services Ltd (AAISCS)
- Laboratory of Medical Physics, AUTH
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
COPD Patients
Asthma Patients
Smokers
C.O.P.D. patients: Presence of a post-bronchodilator forced expiratory volume at one second (FEV1) / forced vital capacity (FVC) < 0.70 with symptoms as dyspnea, chronic cough, chronic sputum production Biofeedback and Neurofeedback Training Varenicline use for smoking cessation Passive Control
Asthma patients: Presence of 2 or more of symptoms of airflow obstruction (cough, wheezing, dyspnea). Airflow obstruction at least partially reversible demonstrated by spirometry with FEV1 increased by >12% following b2 agonist inhalation) or evidence of bronchial hyperresponsiveness by metacholine provocation test (demonstrated by provocative concentration causing a 20% fall (PC20) <8 mg or mannitol provocation test (with FEV1 decrease of 15%) Biofeedback and Neurofeedback Training Varenicline use for smoking cessation Passive Control
Smokers will consist of a group of patients that are under the age of 35, unemployed and healthy according to a standard clinical evaluation. Biofeedback and Neurofeedback Training Varenicline use for smoking cessation Sham Neurofeedback Passive Control