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

NACompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

June 30, 2019

Study Completion Date

June 30, 2019

Conditions
Chronic Obstructive Pulmonary Disease (COPD)AsthmaSmoking
Interventions
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.

Trial Locations (3)

1065

AAI Scientific Cultural Services Ltd (AAISCS), Nicosia

Unknown

National Association of General Practitioners in Bulgaria, Sofia

Laboratory of Medical Physics, AUTH, Thessaloniki

All Listed Sponsors
collaborator

AAI Scientific Cultural Services Ltd (AAISCS)

OTHER

collaborator

NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA

UNKNOWN

lead

Aristotle University Of Thessaloniki

OTHER

NCT02991781 - Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation | Biotech Hunter | Biotech Hunter