Pilot in Greece
The Pilot study scope
The primary scope of SmokeFreeBrain’s pharmacological pilot is to investigate the efficacy of varenicline vs. Neurofeedback (NF) in smoking cessation. In particular, the success in smoking cessation through measurement of the cotinine levels after 12 weeks of varenicline treatment will be assessed. A secondary scope is to assess the possible effects of varenicline during sleep. Finally, an exploratory scope is to investigate the possible changes in quality of life. An integrated pharmacological protocol will be developed, as a smoking cessation aid, which will incorporate varenicline administration. The proposed protocol is expected to induce improvements on sleep quality and quality of life providing a valuable aid for smoking cessation.
Where it is going to take place
The pharmacological treatment consists of 12 weeks of varenicline administration. Two polysomnographic (PSG) measurements will take place: one before the initiation of the treatment, and one after 2-3 weeks. The PSG measurements will take place at the participant’s own residence at the city of Thessaloniki.
Eligibility criteria. Clinical, psychometric and neurophysiological evaluations. Varenicline administration.
Young unemployed smokers aged 18-35 are welcome to participate in the pilot study. Additionally C.O.P.D. and Asthma patients aged 35+ are also eligible. Prior to the initiation of the treatment, all participants will undergo a clinical evaluation at the Smoking Cessation Clinic of the Respiratory Failure Unit, of G.H. “G. Papanikolaou” in Thessaloniki (Dr. Athanasia Pataka, MD), or at the private practice unit of Dr. Chrysoula Kourtidou Papadeli, MD. The initial evaluation will also check the eligibility of the participants. The clinical evaluation will be performed two more times at specific time-points for each participant.
In addition, the participants will undergo a psychometric evaluation at three time-points (before, during, and at a follow-up after the treatment) and a neuropsychological (PSG) evaluation consisting of Sleep-electroencephalography (EEG), Electrooculography (EOG), Electrocardiography (ECG), Electromyography (EMG), as well as snoring and airflow and respiratory effort) at 2 time-points (before, and during the treatment).
The protocol will consist of varenicline administration for 12 weeks. The recommended dose is 1 mg varenicline twice daily following a 1-week titration.
The goal of the varenicline administration is to reduce both craving for nicotine and nicotine withdrawal symptoms, as well as prevent nicotine binding to the receptors, thus blocking the ability of nicotine to stimulate the mesolimbic dopamine system, the neuronal mechanism underlying reinforcement and reward. Thus, the aim of the pharmacological intervention is to induce a brain state that is related to relaxation and serves as a protector against cravings related to addiction. This state is associated with a reverie and disidentification with problems, stress or traumatic experiences.
Benefits for the participants
The participants will have the chance to acquire increased medical care in relation to their attempt to quit smoking, leading to a detailed clinical, psychological, and neuroscientific evaluation. Additionally, by taking part to the intervention, participants will receive both behavioral, and pharmacological assistance and experience protection against stress and all stress-related health problems in their everyday life. There are studies that report adverse drug reaction of “abnormal sleep related events” such as abnormal dreams, nightmares, or somnambulism associated with varenicline. So patients who experience somnambulism or violent dreams while taking varenicline should be advised to consult their health providers.
Study duration
The duration of the intervention is 3 months. The initial clinical, psychometric and PSG measurements will take place one week prior to the initiation of the intervention and the follow-up will take place after 3 months of the initiation of the intervention.
The pilot recording phase will be performed beginning from May 2016 to June 2017.
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Pilot in Bulgaria
The Pilot study scope
It will investigate the effect of motivation for smoking cessation in smoking habits.
Where it is going to take place?
It will take place in Bulgaria, organized by the National association of GPs at some GPs’ ambulatories.
What participants are going to do during the pilot? For how long?
Smokers (at least 10 cigarettes/day with no period of abstinence and more than 3 months passed from that time) with C.O.P.D. (at least 10 pack-years), or asthma, and young unemployed adults.
We’ll use a special tool-kit of questionnaires to assess your motivation. We’ll suggest you a medical examination, a test detecting the CO in the breath exhaled and a spirometry to assess your lungs’ need to get rid of tobacco smoke. Then we’ll repeat this two more times in several months in order to detect improvement as a result of your changed smoking habits.
Pilot study duration
The pilot recording phase will be performed beginning from May 2016 to June 2017.
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Pilot in Serbia
The Pilot study scope
After signed consent the patient will be clinically evaluated. Following to the clinical evaluation, an experienced psychologist will complete the behavioral assessment using a battery of psychometric tests. Within a week of the above mentioned procedure the second appointment will be held at the IPBV and the first polysomnographic recording will be done. The pharmacological treatment with bupropion will start after this recording and the minimum treatment duration is 14 days. At the third visit another polysomnographic recording together with clinical and psychometric evaluation will be completed. Las 2Follow up” visit will be held 10 weeks after the completion of second polysomnographic recording. Maximum treatment period with bupropion is 9 weeks. The expected duration of a subject’s participation from consent to follow up visit is a minimum of 86 days which includes 4 visits.
Where it is going to take place
At the Institute for pulmonary diseses of Vojvodine in Sremska Kamenica
What participants are going to do during the pilot? For how long?
Smokers (at least 10 cigarettes/day and 10 packyears) with diagnosed COPD or asthma, or young unemployed adult
Participants will after clinical and psychometric evaluation participants undergo polysomnographic recordings followed with pharmacological treatment. The clinical evaluation will be done two more times in time period of 3 months.
Benefits for the participants
Pharmacological help in smoking cessation with medical evaluation and increased quality of sleep and daily activities.
Pilot study duration
1 week screening period, pharmacological treatment period (2-9 weeks), follow up. Maximum participation duration is 84 days
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