Sympathovagal Balance in Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474265
• Other study ID #: 201102-TR
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2011
• Last updated: October 24, 2017
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2017
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Germany	University Medical Center	Goettingen

Sponsors (2)

Lead Sponsor	Collaborator
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH	University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	33 weeks
Secondary	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)	33 weeks
Secondary	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	33 weeks
Secondary	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.	33 weeks
Secondary	Assessment of smoking relapse rate	All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires)	33 weeks