Sympathovagal Balance in Smoking Cessation

This study is ongoing, but not recruiting participants.
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: September 12, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 July 29, 2014