Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Asthma; Smoking; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Varenicline use for smoking cessation; Other: Passive Control; Other: Biofeedback and Neurofeedback Training; Other: Sham Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02991781

SEP-210254111

Details and patient eligibility

About

This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.

Full description

This study will develop and experimentally test the efficiency of a neurofeedback(NF) training protocol for smoking cessation. As non-pharmacological, non-invasive and painless brainwave technique, NF contributes to teach individuals how they can take the control of their mind through operant conditioning. NF regulates brain function in natural way. Studies have reported an 80% rate of reducing or eliminating the need for traditional medication14. Therefore, other nicotine substitutes (such as varenicline) which may carry their own toxicity risk factor may become redundant. The protocol will include 5 bio- and 25 Neuro-feedback sessions, lasting approximately 36 months.

The electrophysiological evaluation of the efficacy of the intervention will include EEG resting state and a multifeature Mismatch Negativity (MMN) evoked response measurements before and after the participation of human volunteers. These data will be analyzed in terms of cortical activation patterns and cortical connectivity. Questionnaires will be used to collect behavioral and psychometric data regarding smoking related behaviors. Additionally, a clinical evaluation including spirometry, exhaled carbon monoxide, total antioxidant capacity, vitamine E, and cotinine will be conducted. The data will be collected prior, during, after the completion of the study and after a one-year follow up.

The Neurofeedback intervention will be compared to a different group of participants that will follow an intervention based on varenicline use for approximately 3 months. The electrophysiological evaluation of the efficacy of the intervention will include EEG resting state and a sleep polysomnography measurement. Questionnaires and clinical evaluation include the same measurements as the neurofeedback intervention but only in 3 time points: prior, during, after the completion of the study.

Enrollment: 106 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 3 patient groups

COPD Patients

Experimental group

Description:

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

Treatment:

Other: Biofeedback and Neurofeedback Training

Other: Passive Control

Drug: Varenicline use for smoking cessation

Asthma Patients

Experimental group

Description:

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

Treatment:

Other: Biofeedback and Neurofeedback Training

Other: Passive Control

Drug: Varenicline use for smoking cessation

Smokers

Experimental group

Description:

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

Treatment:

Other: Sham Neurofeedback

Other: Biofeedback and Neurofeedback Training

Other: Passive Control

Drug: Varenicline use for smoking cessation