This study has the following primary aim: \- the main objective of this study is to investigate the effects of smoking cessation during quit attempts on sympathovagal balance. These effects will be observed in smokers quitting smoking with pharmacological support or without. Secondary aims of this study are also: * the definition of MSNA in smokers and non-smokers * the investigation of other parameters concerning the autonomic nervous system, like baroreflex-sensitivity, heart rate-variability before and during the quit attempt. * the definition of withdrawal symptoms and craving before, during and after the quit attempt. * the investigation of effects of smoking cues on craving and sympathovagal balance * the investigation of relapse rates after smoking cessation in correlation with the parameters mentioned above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
0.5-2 mg per day, oral use
1-2 tablets per day, oral use
10-15 mg per day, transdermal use (patches)
University Medical Center
Göttingen, Germany
Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
Patients present 7 weeks before their personal smoking-stop-day and participate in the study until week 26 after their personal smoking-stop-day. During that time, MSNA is recorded.
Time frame: 33 weeks
Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers
first MSNA is carried out 4 weeks before smoking-stop-day (respectively 6 weeks for group D). second and last MSNA is carried out two days after smoking-stop-day (respectively 2 weeks before smoking-stop-day for group D)
Time frame: 33 weeks
Assessment of craving and withdrawal symptoms during smoking cessation
withdrawal symptoms data is collected by phone calls 3,2,1 days before smoking-stop-day, the day itself and 1 day and 11 (12 for group C and D) weeks after smoking-stop-day. Also the withdrawal symptoms date is collected during each personal examination (means - Pre-Examination, Baseline, Follow I to III). The data will be collected by reliable questionnaires
Time frame: 33 weeks
Assessment of smoking cues on craving and sympathovagal balance
smoking cues will be presented on the first follow-up-measurement to members of group A-D.
Time frame: 33 weeks
Assessment of smoking relapse rate
All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires)
Time frame: 33 weeks
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