MedTrace Logo

Sympathovagal Balance in Smoking Cessation

NCT01474265 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-10-25

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

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)

Sponsors & Collaborators

  • University Medical Center Goettingen

    collaborator OTHER

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    lead OTHER

Principal Investigators

  • Tobias Raupach, MD · University Medical Center Goettingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474265 on ClinicalTrials.gov