Sympathovagal Balance in Smoking Cessation

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH (Other)

Overall Status

Completed

CT.gov ID

NCT01474265

Collaborator

University Medical Center Goettingen (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: Varenicline Drug: Placebo Drug: Nicorette TX	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: varenicline placebo	Drug: Placebo 1-2 tablets per day, oral use
Active Comparator: varenicline	Drug: Varenicline 0.5-2 mg per day, oral use
Active Comparator: Nicorette TX	Drug: Nicorette TX 10-15 mg per day, transdermal use (patches)
Active Comparator: Nicorette TX optional	Drug: Nicorette TX 10-15 mg per day, transdermal use (patches)
No Intervention: control group smokers

Outcome Measures

Primary Outcome Measures

Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation. [33 weeks]
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.

Secondary Outcome Measures

Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers [33 weeks]
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)
Assessment of craving and withdrawal symptoms during smoking cessation [33 weeks]
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
Assessment of smoking cues on craving and sympathovagal balance [33 weeks]
smoking cues will be presented on the first follow-up-measurement to members of group A-D.
Assessment of smoking relapse rate [33 weeks]
All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)