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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02991781 |
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Date of registration:
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05/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation
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Scientific title:
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Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02991781 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bulgaria
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Cyprus
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Greece
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Contacts
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Name:
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Panos Bamidis, Ass. Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical School, Aristotle University of Thessaloniki |
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Key inclusion & exclusion criteria
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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
Exclusion Criteria:
- Diagnosed neurological, mental or psychiatric illness
- Drug-resistance epilepsy
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Smoking
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Chronic Obstructive Pulmonary Disease (COPD)
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Intervention(s)
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Other: Passive Control
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Other: Biofeedback and Neurofeedback Training
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Other: Sham Neurofeedback
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Drug: Varenicline use for smoking cessation
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Primary Outcome(s)
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Neurofeedback vs. Varenicline efficacy for smoking cessation
[Time Frame: 2 years]
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Secondary Outcome(s)
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General health
[Time Frame: 2 years]
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Depression
[Time Frame: 2 years]
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Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity
[Time Frame: 2 years]
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Effectiveness in changing quality of life as measured by EuroQL-5D
[Time Frame: 2 years]
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Neuroplastic effects of combined bio- and neuro- feedback training in the mismatch negativity response
[Time Frame: 2 years]
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Anxiety
[Time Frame: 2 years]
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Sleep quality during varenicline use
[Time Frame: 2 years]
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Secondary ID(s)
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SEP-210254111
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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