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| Name | Class |
|---|---|
| University Medical Center Goettingen | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline placebo | Placebo Comparator |
| |
| varenicline | Active Comparator |
| |
| Nicorette TX | Active Comparator |
| |
| Nicorette TX optional | Active Comparator |
| |
| control group smokers | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 0.5-2 mg per day, oral use |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers | 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) | 33 weeks |
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Inclusion Criteria:
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:
signs that predict a possible non-compliance of the patient
exclusion because of nicorette tx:
exclusion because of varenicline
Exclusion because of methods
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)
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Raupach, MD | University Medical Center Goettingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Göttingen | 37075 | Germany |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
1-2 tablets per day, oral use |
|
| Nicorette TX | Drug | 10-15 mg per day, transdermal use (patches) |
|
| Assessment of craving and withdrawal symptoms during smoking cessation |
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 |
| 33 weeks |
| Assessment of smoking cues on craving and sympathovagal balance | smoking cues will be presented on the first follow-up-measurement to members of group A-D. | 33 weeks |
| Assessment of smoking relapse rate | All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires) | 33 weeks |
| D011810 | Quinoxalines |