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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991781
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
AAI Scientific Cultural Services Ltd (AAISCS)
NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA
Information provided by (Responsible Party):
Panos Bamidis, Aristotle University Of Thessaloniki

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Asthma Smoking Other: Biofeedback and Neurofeedback Training Drug: Varenicline use for smoking cessation Other: Sham Neurofeedback Other: Passive Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking
Study Start Date : January 2017
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPD Patients

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

Other: Biofeedback and Neurofeedback Training
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.
Other Name: Neurofeedback

Drug: Varenicline use for smoking cessation
The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.
Other Name: Varenicline

Other: Passive Control
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.

Experimental: Asthma Patients

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

Other: Biofeedback and Neurofeedback Training
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.
Other Name: Neurofeedback

Drug: Varenicline use for smoking cessation
The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.
Other Name: Varenicline

Other: Passive Control
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.

Experimental: Smokers

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

Other: Biofeedback and Neurofeedback Training
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.
Other Name: Neurofeedback

Drug: Varenicline use for smoking cessation
The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.
Other Name: Varenicline

Other: Sham Neurofeedback
Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.
Other Name: Active Control

Other: Passive Control
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.




Primary Outcome Measures :
  1. Neurofeedback vs. Varenicline efficacy for smoking cessation [ Time Frame: 2 years ]
    The outcome measure is the effect size of each intervention measured in standardized percentage of participants that give up smoking.


Secondary Outcome Measures :
  1. Effectiveness in changing quality of life as measured by EuroQL-5D [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the scoring of the a questionnaire evaluating quality of life (EuroQL-5D), after the completion of the intervention.

  2. General health [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the scoring of the General Health Questionnaire which is evaluating general health, after the completion of the intervention.

  3. Depression [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the scoring of the Beck's Depression Inventory, which is evaluating depression, after the completion of the intervention.

  4. Anxiety [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the scoring of the Spielberger's State -Trait Anxiety Inventory , which is evaluating anxiety, after the completion of the intervention.

  5. Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the activation of the resting state cortical network after the completion of the intervention.

  6. Neuroplastic effects of combined bio- and neuro- feedback training in the mismatch negativity response [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the activation of the Mismatch Negativity response of the auditory cortex after the completion of the intervention.

  7. Sleep quality during varenicline use [ Time Frame: 2 years ]
    The outcome measure is the change from baseline in the scoring in psychometric tests evaluating sleep quality.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991781


Locations
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Bulgaria
National Association of General Practitioners in Bulgaria
Sofia, Bulgaria
Cyprus
AAI Scientific Cultural Services Ltd (AAISCS)
Nicosia, Cyprus, 1065
Greece
Laboratory of Medical Physics, AUTH
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
AAI Scientific Cultural Services Ltd (AAISCS)
NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA
Investigators
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Principal Investigator: Panos Bamidis, Ass. Prof Medical School, Aristotle University of Thessaloniki
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: neurofeedback-auth

Publications:
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Responsible Party: Panos Bamidis, Dr. Panagiotis Bamidis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02991781    
Other Study ID Numbers: SEP-210254111
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Time Frame: Upon completion of the study
Access Criteria: Following communication with the Principal Investigator
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs