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

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH1 site in 1 country85 target enrollmentNovember 2011

ConditionsSmoking Cessation

InterventionsVarenicline Nicorette TX Placebo

DrugsVarenicline Placebo Nicorette TX

Overview

Phase: Phase 4
Intervention: Varenicline
Conditions: Smoking Cessation
Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Enrollment: 85
Locations: 1
Primary Endpoint: Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

April 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Responsible Party

Sponsor

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 \>
•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

Arms & Interventions

varenicline

Intervention: Varenicline

Nicorette TX

Intervention: Nicorette TX

varenicline placebo

Intervention: Placebo

Nicorette TX optional

Intervention: Nicorette TX

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers(33 weeks)
Assessment of craving and withdrawal symptoms during smoking cessation(33 weeks)
Assessment of smoking cues on craving and sympathovagal balance(33 weeks)
Assessment of smoking relapse rate(33 weeks)