drugset / Trial / NCT01474265

Sympathovagal Balance in Smoking Cessation

NCT01474265

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-11
Primary completion
2012-12
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicorette TX Unknown 10 mg Other
Comparator Nicorette TX Unknown 15 mg Other
Comparator Varenicline Small molecule 0.5 mg Oral
Comparator Varenicline Small molecule 2 mg Oral

Indications

No indication recorded.