Sympathovagal Balance in Smoking Cessation - Full Text View

Purpose

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	Intervention	Phase
Smoking Cessation	Drug: Varenicline Drug: Placebo Drug: Nicorette TX	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

Primary Outcome Measures:

Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
smoking cues will be presented on the first follow-up-measurement to members of group A-D.
Assessment of smoking relapse rate [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires)

Estimated Enrollment:	85
Study Start Date:	November 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474265

Locations

Germany
University Medical Center
Goettingen, Germany, 37075

Sponsors and Collaborators

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

University Medical Center Goettingen

Investigators

Principal Investigator:

Tobias Raupach, MD

University Medical Center Goettingen

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:	NCT01474265 History of Changes
Other Study ID Numbers:	201102-TR
Study First Received:	November 3, 2011
Last Updated:	September 12, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

smoking cessation
varenicline
sympathovagal balance
quit attempts
MSNA

Additional relevant MeSH terms:

Smoking
Habits
Nicotine
Nicotine polacrilex
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013