ACTRN12618001792213已完成4 期
Evaluating the efficacy and safety of varenicline as a sole pharmacotherapy vs. in combination with nicotine replacement therapy (NRT) lozenges in assisting smoking cessation among hospitalised smokers: study protocol for a randomised controlled trial
Monash University, Faculty of Pharmacy and Pharmaceutical Sciences, Centre for Medicine Use and Safety0 个研究点目标入组 320 人开始时间: 2018年11月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults aged 18 years or over, admitted to participating hospitals with a history of smoking 10 or more cigarettes per day on average in the four weeks prior to their hospital admission, interested in quitting smoking, willing to use pharmacotherapy and available for 12 months follow-up post-discharge and willing/capable to provide signed informed consent will be eligible for the study. This study will not recruit any outpatient smokers.
排除标准
- •Patients who do not meet all of the above inclusion criteria, those who have a terminal illness with an anticipated survival of of less than 6 months, those who have an unstable cardiovascular status or a current major psychiatric illness as well as those admitted to outpatient clinics will be excluded from the study. Patients unable to communicate in English and provide written consent will also be excluded due to the potential need to regularly communicate with the investigators during the entire trial period and the lack of funding available for interpreters. Further exclusion criteria for this study are women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months, patients who are current (on the day of hospital admission) users of smoking cessation medications or approaches (i.e. NRT, varenicline, bupropion [Zyban™], clonidine, nortriptyline, electronic nicotine cigarettes), those currently participating in other smoking cessation programs or study, patients who have completed a 12 weeks or longer course of varenicline in the 12 months prior to their hospitalisation, those who have had intolerable adverse reactions from the use of varenicline or NRTs in the past as well as people who have contraindications for their use (including those using medications known to have major interactions with either varenicline or NRT).
研究者
相似试验
已完成
3 期
Evaluation of Varenicline on cognitive impairement in patient with schizophreniaIRCT20101108005138N4Sari University of Medical Sciences96
进行中（未招募）
1 期
We try to assess the effectiveness and safety of Varenicline for smoking cessation in hospitalized patients with psychiatric disorders.Smoking cessation in hospitalized patients with psychiatric disorders.EUCTR2017-004715-40-ESFundació Hospital Universitari Vall d’Hebron-Institut de Recerca (VHIR)124
已完成
2 期
The effect of varenicline on depression in smokersmajor depressive disorder.Major depressive disorder, single episodeIRCT20190308042972N1Yazd University of Medical Sciences60
尚未招募
2 期
Clinical evaluation of VAYU KEELAGA ILAKAM (Internal) with ERUKKATHY THYLAM (External)in the treatment of MUDAKKU VATHAM .CTRI/2018/04/013541Ayothidoss Pandithar Hospital
招募中
1 期
Trial of varenicline (Champix) for the treatment of spinocerebellar degeneratioJPRN-UMIN000011560iigata University40