Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation
Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking
1 other identifier
interventional
106
3 countries
3
Brief Summary
This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFebruary 17, 2020
February 1, 2020
2.4 years
May 5, 2015
February 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Neurofeedback vs. Varenicline efficacy for smoking cessation
The outcome measure is the effect size of each intervention measured in standardized percentage of participants that give up smoking.
2 years
Secondary Outcomes (7)
Effectiveness in changing quality of life as measured by EuroQL-5D
2 years
General health
2 years
Depression
2 years
Anxiety
2 years
Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity
2 years
- +2 more secondary outcomes
Study Arms (3)
COPD Patients
EXPERIMENTALC.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
EXPERIMENTALAsthma 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
EXPERIMENTALSmokers 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
Interventions
The protocol will consist of 5 sessions of skin temperature biofeedback and 20 sessions of a neurofeedback training protocol that will consist of Alpha-Theta ratio up-training. The aim of the training is to reach a crossover state, were initially Alpha activity will increase and then in a deeper state, the Theta activity will take over. This state is associated with a reverie and disidentification with problems, stress or traumatic experiences. Therefore, the subjects will learn how to increase their Theta/Alpha ratio.
The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.
Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.
Subjects will not receive any intervention, but they will be measured via a clinical and psychometric evaluation with a time-difference of 3 months. This is equal to the intervention time. Hence, the subjects in this intervention type will serve as a control group for the analysis and design of the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosed neurological, mental or psychiatric illness
- Drug-resistance epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
National Association of General Practitioners in Bulgaria
Sofia, Bulgaria
AAI Scientific Cultural Services Ltd (AAISCS)
Nicosia, 1065, Cyprus
Laboratory of Medical Physics, AUTH
Thessaloniki, Greece
Related Publications (2)
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.
PMID: 29295041BACKGROUNDPandria N, Athanasiou A, Styliadis C, Terzopoulos N, Mitsopoulos K, Paraskevopoulos E, Karagianni M, Pataka A, Kourtidou-Papadeli C, Makedou K, Iliadis S, Lymperaki E, Nimatoudis I, Argyropoulou-Pataka P, Bamidis PD. Does combined training of biofeedback and neurofeedback affect smoking status, behavior, and longitudinal brain plasticity? Front Behav Neurosci. 2023 Jan 27;17:1096122. doi: 10.3389/fnbeh.2023.1096122. eCollection 2023.
PMID: 36778131DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Panos Bamidis, Ass. Prof
Medical School, Aristotle University of Thessaloniki
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Panagiotis Bamidis
Study Record Dates
First Submitted
May 5, 2015
First Posted
December 14, 2016
Study Start
January 1, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Upon completion of the study
- Access Criteria
- Following communication with the Principal Investigator
Individual Patient Data (IPD) will be shared after obtaining the consent of the participants. The consent form will inform the participants for this attribute of the data. The repository will be based on popular open source software (CKAN) and it'll be accessible through a portal (endpoint) at the following address: ckan.smokefreebrain.eu CKAN is a powerful data management system that makes data accessible - by providing tools to streamline publishing, sharing, finding and using data. CKAN is aimed at data publishers (national and regional governments, companies and organizations) wanting to make their data open and available.