NCT01474265已完成4 期
Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women at the age of 25 to 60 years.
- •Group A-D: Smokers willing to quit smoking and a FTNA-result >
- •Group E: Never-smokers.
- •Signed consent after information.
排除标准
- •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
- •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)
研究组 & 干预措施
varenicline
Active Comparator
干预措施: Varenicline (Drug)
Nicorette TX
Active Comparator
干预措施: Nicorette TX (Drug)
varenicline placebo
Placebo Comparator
干预措施: Placebo (Drug)
Nicorette TX optional
Active Comparator
干预措施: Nicorette TX (Drug)
结局指标
主要结局
Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
时间窗: 33 weeks
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.
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus PropofolGeneral AnestheticsNCT05635201Daegu Catholic University Medical Center78
已完成
不适用
Role of the Autonomic Nervous System in HIV-LipodystrophyLipodystrophy-SyndromeHIV InfectionsNCT00149097Hannover Medical School54
招募中
不适用
Definition of Autonomic Nervous System Involvement in Patients With Multiple SclerosisMultiple SclerosisNCT05748015Istituti Clinici Scientifici Maugeri SpA60
已完成
不适用
Autonomic Nervous System Modulation During Laparoscopic ProstatectomyIntervention Affecting Autonomic Nervous SystemNCT01927380ASST Fatebenefratelli Sacco37
已完成
不适用
Autonomic Nervous System Function Following Bariatric SurgeryBariatric SurgeryNCT00948545Christiana Care Health Services37