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

Asthma Clinical Trial

Official title:

Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991781
• Other study ID #: SEP-210254111
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: February 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smoking

Intervention

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.

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:
• 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.
• 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.

Locations

Country	Name	City	State
Bulgaria	National Association of General Practitioners in Bulgaria	Sofia
Cyprus	AAI Scientific Cultural Services Ltd (AAISCS)	Nicosia
Greece	Laboratory of Medical Physics, AUTH	Thessaloniki

Sponsors (3)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	AAI Scientific Cultural Services Ltd (AAISCS), NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA

Countries where clinical trial is conducted

Bulgaria,  Cyprus,  Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effectiveness in changing quality of life as measured by EuroQL-5D	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 years
Secondary	General health	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.	2 years
Secondary	Depression	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.	2 years
Secondary	Anxiety	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.	2 years
Secondary	Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity	The outcome measure is the change from baseline in the activation of the resting state cortical network after the completion of the intervention.	2 years
Secondary	Neuroplastic effects of combined bio- and neuro- feedback training in the mismatch negativity response	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.	2 years
Secondary	Sleep quality during varenicline use	The outcome measure is the change from baseline in the scoring in psychometric tests evaluating sleep quality.	2 years

External Links

•   SmokeFreeBrain Project web-site