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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neural Mechanisms Associated With Risk of Smoking Relapse

NCT02837510

Nicotine Addiction

COMPLETED NA

Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence

NCT03276780

Smoking Cessation

COMPLETED PHASE4

Smoking Cessation Intervention in Respiratory Inpatients

NCT02922387

Pulmonary Disease, Chronic Obstructive Asthma Community Acquired Pneumonia

COMPLETED PHASE4

Pain and Smoking Study

NCT02971137

Smoking Pain Smoking Cessation

COMPLETED NA

Smoking Study With Behavioral Therapy for Hypertensive Patients

NCT00879177

Cigarette Smoking Hypertension

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD) Asthma Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD Patients

C.O.P.D. patients: Presence of a post-bronchodilator forced expiratory volume at one second (FEV1) / forced vital capacity (FVC) \< 0.70 with symptoms as dyspnea, chronic cough, chronic sputum production

Biofeedback and Neurofeedback Training

Varenicline use for smoking cessation

Passive Control

Group Type EXPERIMENTAL

Biofeedback and Neurofeedback Training

Intervention Type OTHER

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.

Varenicline use for smoking cessation

Intervention Type DRUG

The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.

Passive Control

Intervention Type OTHER

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.

Asthma Patients

Asthma patients: Presence of 2 or more of symptoms of airflow obstruction (cough, wheezing, dyspnea). Airflow obstruction at least partially reversible demonstrated by spirometry with FEV1 increased by \>12% following b2 agonist inhalation) or evidence of bronchial hyperresponsiveness by metacholine provocation test (demonstrated by provocative concentration causing a 20% fall (PC20) \<8 mg or mannitol provocation test (with FEV1 decrease of 15%)

Biofeedback and Neurofeedback Training

Varenicline use for smoking cessation

Passive Control

Group Type EXPERIMENTAL

Biofeedback and Neurofeedback Training

Intervention Type OTHER

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.

Varenicline use for smoking cessation

Intervention Type DRUG

The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.

Passive Control

Intervention Type OTHER

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.

Smokers

Smokers will consist of a group of patients that are under the age of 35, unemployed and healthy according to a standard clinical evaluation.

Biofeedback and Neurofeedback Training

Varenicline use for smoking cessation

Sham Neurofeedback

Passive Control

Group Type EXPERIMENTAL

Biofeedback and Neurofeedback Training

Intervention Type OTHER

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.

Varenicline use for smoking cessation

Intervention Type DRUG

The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.

Sham Neurofeedback

Intervention Type OTHER

Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.

Passive Control

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Varenicline use for smoking cessation

The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neurofeedback Varenicline Active Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 C.O.P.D.
* Age \< 35, for the group of Young Unemployed
* Age \>35 years, for the groups of Asthma and C.O.P.D. patients