Sympathovagal Balance in Smoking Cessation

NCT01474265 | Completed Phase 4

• 1 other identifier: 201102-TR
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

smoking cessation; varenicline; sympathovagal balance; quit attempts; MSNA

Outcome Measures

Primary Outcomes (1)

• Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.

  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.

  33 weeks

Secondary Outcomes (4)

• Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers

  33 weeks

• Assessment of craving and withdrawal symptoms during smoking cessation

  33 weeks

• Assessment of smoking cues on craving and sympathovagal balance

  33 weeks

• Assessment of smoking relapse rate

  33 weeks

Study Arms (5)

varenicline placebo

PLACEBO COMPARATOR

Drug: Placebo

varenicline

ACTIVE COMPARATOR

Drug: Varenicline

Nicorette TX

ACTIVE COMPARATOR

Drug: Nicorette TX

Nicorette TX optional

ACTIVE COMPARATOR

Drug: Nicorette TX

control group smokers

NO INTERVENTION

Interventions

Varenicline DRUG

0.5-2 mg per day, oral use

varenicline

Placebo DRUG

1-2 tablets per day, oral use

varenicline placebo

Nicorette TX DRUG

10-15 mg per day, transdermal use (patches)

Nicorette TX; Nicorette TX optional

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• psoriasis, dermatitis, urticaria
• creatinine-clearance \< 30ml/min
• epilepsy
• psychiatric diseases (schizophrenia, bipolar disorders, depression).
• Diseases that increase the sympathetic level (Heart insufficiency, high blood pressure (arteria /pulmonary), obstructive sleeping apnoea, COPD)

Sponsors & Collaborators

• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: lead
• University Medical Center Goettingen: collaborator

Study Sites (1)

University Medical Center

Göttingen, 37075, Germany

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Tobias Raupach, MD

  University Medical Center Goettingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

DE (1)