Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation
Condition: Chronic Obstructive Pulmonary Disease (COPD); Asthma; Smoking
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

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.
    

Intervention name(s): Biofeedback and Neurofeedback Training; Varenicline use for smoking cessation; Sham Neurofeedback; Passive Control
Intervention type(s): Other; Drug; Other; Other
Intervention description(s): 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.
Other intervention name(s): Neurofeedback; Varenicline; Active Control
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research