Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
85 participants
INTERVENTIONAL
2011-11-30
2013-04-30
Brief Summary
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\- 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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varenicline placebo
Placebo
1-2 tablets per day, oral use
varenicline
Varenicline
0.5-2 mg per day, oral use
Nicorette TX
Nicorette TX
10-15 mg per day, transdermal use (patches)
Nicorette TX optional
Nicorette TX
10-15 mg per day, transdermal use (patches)
control group smokers
No interventions assigned to this group
Interventions
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Varenicline
0.5-2 mg per day, oral use
Placebo
1-2 tablets per day, oral use
Nicorette TX
10-15 mg per day, transdermal use (patches)
Eligibility Criteria
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Inclusion Criteria
* Group A-D: Smokers willing to quit smoking and a FTNA-result \>5.
* Group E: Never-smokers.
* Signed consent after information.
Exclusion Criteria
* 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)
25 Years
60 Years
ALL
Yes
Sponsors
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University Medical Center Goettingen
OTHER
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
OTHER
Responsible Party
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Principal Investigators
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Tobias Raupach, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Goettingen
Locations
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University Medical Center
Göttingen, , Germany
Countries
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Other Identifiers
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201102-TR
Identifier Type: -
Identifier Source: org_study_id