Sympathovagal Balance in Smoking Cessation

Institut für anwendungsorientierte Forschung und klinische Studien

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Varenicline; Drug: Placebo; Drug: Nicorette TX

Study type: Interventional

Funder types: Other

Identifiers

NCT01474265

201102-TR

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 5 patient groups, including a placebo group

varenicline placebo

Placebo Comparator group

Treatment:

Drug: Placebo

varenicline

Active Comparator group

Treatment:

Drug: Varenicline

Nicorette TX

Active Comparator group

Treatment:

Drug: Nicorette TX

Nicorette TX optional

Active Comparator group

Treatment:

Drug: Nicorette TX

control group smokers

No Intervention group