Sympathovagal Balance in Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
University Medical Center Goettingen
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT01474265
First received: November 3, 2011
Last updated: August 7, 2014
Last verified: August 2014

November 3, 2011
August 7, 2014
November 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01474265 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Sympathovagal Balance in Smoking Cessation
Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: Varenicline
    0.5-2 mg per day, oral use
  • Drug: Placebo
    1-2 tablets per day, oral use
  • Drug: Nicorette TX
    10-15 mg per day, transdermal use (patches)
  • Placebo Comparator: varenicline placebo
    Intervention: Drug: Placebo
  • Active Comparator: varenicline
    Intervention: Drug: Varenicline
  • Active Comparator: Nicorette TX
    Intervention: Drug: Nicorette TX
  • Active Comparator: Nicorette TX optional
    Intervention: Drug: Nicorette TX
  • No Intervention: control group smokers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
April 2013
December 2012   (final data collection date for primary outcome measure)

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)
Both
25 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01474265
201102-TR
No
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Principal Investigator: Tobias Raupach, MD University Medical Center Goettingen
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP