Clinical trial NCT02991781: Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation
Official title: Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Smoking
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: AAI Scientific Cultural Services Ltd (AAISCS)
name: NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA
First posted: 2016-12-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

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

Primary outcomes:
measure: Neurofeedback vs. Varenicline efficacy for smoking cessation
timeFrame: 2 years
Secondary outcomes:
measure: Effectiveness in changing quality of life as measured by EuroQL-5D
timeFrame: 2 years
measure: General health
timeFrame: 2 years
measure: Depression
timeFrame: 2 years
measure: Anxiety
timeFrame: 2 years
measure: Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity
timeFrame: 2 years
measure: Neuroplastic effects of combined bio- and neuro- feedback training in the mismatch negativity response
timeFrame: 2 years
measure: Sleep quality during varenicline use
timeFrame: 2 years
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: National Association of General Practitioners in Bulgaria
city: Nicosia
country: Cyprus
facility: AAI Scientific Cultural Services Ltd (AAISCS)
city: Thessaloniki
country: Greece
facility: Laboratory of Medical Physics, AUTH
Study officials:
affiliation: Medical School, Aristotle University of Thessaloniki
name: Panos Bamidis, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bamidis PD, Paraskevopoulos E, Konstantinidis E, Spachos D, Billis A. Multimodal e-Health Services for Smoking Cessation and Public Health: The SmokeFreeBrain Project Approach. Stud Health Technol Inform. 2017;245:5-9.