Status:
COMPLETED
Sympathovagal Balance in Smoking Cessation
Lead Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborating Sponsors:
University Medical Center Goettingen
Conditions:
Smoking Cessation
Eligibility:
All Genders
25-60 years
Phase:
PHASE4
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- Men and Women at the age of 25 to 60 years.
- Group A-D: Smokers willing to quit smoking and a FTNA-result \>5.
- Group E: Never-smokers.
- Signed consent after information.
Exclusion
- formerly known hypersensitivity against one of the used pharmacological interventions or structurally similar drugs or against one of the ingredients.
- participation in another study during this study or within 4 weeks prior to this study.
- Addiction or other circumstances that prevent the patient from estimating the study and the consequences.
- Pregnancy and breast-feeding
- women with childbearing potential, except women that fulfill the following criteria:
- post menopause
- postoperative (6 weeks after both-sides ovariectomy with or without hysterectomy)
- regular and correct use of prevention methods (error-rate \<1% a year), e.g. implants, depot injections, oral contraceptives, IUP)
- sexual abstinence
- signs that predict a possible non-compliance of the patient
- exclusion because of nicorette tx:
- psoriasis, dermatitis, urticaria
- exclusion because of varenicline
- creatinine-clearance \< 30ml/min
- epilepsy
- psychiatric diseases (schizophrenia, bipolar disorders, depression).
- Exclusion because of methods
- Diseases that increase the sympathetic level (Heart insufficiency, high blood pressure (arteria /pulmonary), obstructive sleeping apnoea, COPD)
- cardiac rhythm disturbances
- myocardial infarction within the last 8 weeks
- polyneuropathy
- diseases that come along with damages of peripheral nerves
- severe or life-threatening diseases (e.g. cancer with life-expectancy \< 5 years, terminal kidney-insufficiency)
- treatment with antihypertensive drugs or sympathomimetic substances (e.g.theophyllin) or smoking cessation medication (NRT, Varenicline)
- Other reasons, that make a patient not suitable for the study (estimation of primary investigator)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01474265
Start Date
November 1 2011
End Date
April 1 2013
Last Update
October 25 2017
Active Locations (1)
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1
University Medical Center
Göttingen, Germany, 37075