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Completed

NCT Number: NCT02991781

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Association of General Practitioners in Bulgaria, Sofia, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback and Neurofeedback Training

Other

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 names: Neurofeedback

Varenicline use for smoking cessation

Drug

The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.

Other names: Varenicline

Sham Neurofeedback

Other

Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.

Other names: Active Control

Passive Control

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • AAI Scientific Cultural Services Ltd (AAISCS)
  • NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2016
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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