NCT02991781.

Trial name or title	Combined bio‐ and neuro‐ feedback vs. varenicline use for smoking cessation
Methods	Randomised, parallel‐group, open‐label trial
Participants	140 participants: 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 COPD Age < 35, for the group of young unemployed Age > 35 years, for the groups of asthma and COPD patients Exclusion criteria: Diagnosed neurological, mental, or psychiatric illness Drug‐resistant epilepsy
Interventions	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 control of their mind through operant conditioning. NF regulates brain function in a natural way. 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 cross‐over 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. Participants will therefore will learn how to increase their Theta/Alpha ratio. The neurofeedback intervention will be compared with a different group of participants receiving 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 at 3 time points: prior, during, after the completion of the study.
Outcomes	Standardised percentage of participants that give up smoking (Time Frame 2 years)
Starting date	January 2017
Contact information	Professor Panos Bamidis bamidis@auth.gr
Notes	Not sure if it will be possible to isolate the effect of biofeedback