Clinical trial NCT01474265: Sympathovagal Balance in Smoking Cessation
Official title: Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation
varenicline
sympathovagal balance
quit attempts
MSNA
Lead sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor class: OTHER
Collaborators: name: University Medical Center Goettingen
First posted: 2011-11-18
Enrollment: 85
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
timeFrame: 33 weeks
Secondary outcomes:
measure: Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers
timeFrame: 33 weeks
measure: Assessment of craving and withdrawal symptoms during smoking cessation
timeFrame: 33 weeks
measure: Assessment of smoking cues on craving and sympathovagal balance
timeFrame: 33 weeks
measure: Assessment of smoking relapse rate
timeFrame: 33 weeks
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: University Medical Center
Study officials:
affiliation: University Medical Center Goettingen
name: Tobias Raupach, MD
role: PRINCIPAL_INVESTIGATOR
References: