Sympathovagal Balance in Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01474265
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : October 25, 2017
University Medical Center Goettingen
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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 Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Varenicline

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers [ Time Frame: 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)

  2. Assessment of craving and withdrawal symptoms during smoking cessation [ Time Frame: 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

  3. Assessment of smoking cues on craving and sympathovagal balance [ Time Frame: 33 weeks ]
    smoking cues will be presented on the first follow-up-measurement to members of group A-D.

  4. Assessment of smoking relapse rate [ Time Frame: 33 weeks ]
    All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires)

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01474265

University Medical Center
Goettingen, Germany, 37075
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Principal Investigator: Tobias Raupach, MD University Medical Center Goettingen

Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH Identifier: NCT01474265     History of Changes
Other Study ID Numbers: 201102-TR
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
smoking cessation
sympathovagal balance
quit attempts

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents