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

Summary

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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma
• Smoking

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.

Sponsors & Collaborators

• AAI Scientific Cultural Services Ltd (AAISCS)

  collaborator OTHER

• NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA

  collaborator UNKNOWN

• Aristotle University Of Thessaloniki

  lead OTHER

Principal Investigators

• Panos Bamidis, Ass. Prof · Medical School, Aristotle University of Thessaloniki

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• Bulgaria
• Cyprus
• Greece

Study Locations