NCT02991781

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma
• Smoking

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-12-14
• Last updated: 2020-02-17

Locations

3 sites across 3 countries: Bulgaria, Cyprus, Greece