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Completed

NCT Number: NCT01474265

Sympathovagal Balance in Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Varenicline

Drug

0.5-2 mg per day, oral use

Placebo

Drug

1-2 tablets per day, oral use

Nicorette TX

Drug

10-15 mg per day, transdermal use (patches)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Other

Collaborators

  • University Medical Center Goettingen

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 18, 2011
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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