Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Participant's Smoking Status
研究概览
简要总结
The purpose of this vanguard trial is to test whether clients of Sun Life are willing to join in a quit smoking program that offers counselling and tobacco cessation products to all participants over a 12-month period. The study team will track the safety and usage of 3 types of cessation products as well as the effectiveness of a virtual pharmacy (i.e. cessation products delivered to participants directly from a pharmacy). The goal is to recruit a minimum of 150 participants for this Vanguard phase.
The purpose of this study is to look at 3 approved smoking cessation products used in combination with counselling and virtual delivery of the smoking cessation products. The goal is to track product usage, safety, and adherence (how much of the products people use and how many counselling sessions they complete).
Within the study there will also be an observational group who will not receive study medication but who will receive free virtual coaching and follow-up for smoking cessation and complete study questionnaires.
详细描述
This vanguard study will engage people who smoke through an insurance-based outreach program (Sun Life Assurance Company of Canada) to evaluate the efficacy and safety of three pharmacotherapy arms (combination NRT, cytisine, or varenicline) within the OMSC framework, which includes the provision of cost-free virtual counselling, follow-up, and direct-to-consumer delivery of medications.
To our knowledge, there are no prior studies evaluating an entirely virtual smoking cessation intervention which includes virtual counselling/follow-up and direct-to-consumer delivery of pharmacotherapy. This study will also engage the broader community setting, such as clients or employees of industry partners, represents a valuable opportunity to reach a wider population of people who smoke with tailored support. Beyond cost savings associated with smoking cessation, this study may also reduce insurance premiums for patients, thus leading to additional source of cost savings.
The goal is to recruit a minimum of 150 participants for this Vanguard phase. If successful, recruitment will continue until the budget is finished, or, until additional funding is received to support a full-scale trial (N=1650 participants).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Current cigarette smokers (more than 5 cigarettes per day) who are interested in reducing or quitting in the next 6 months.
- •Able to provide informed consent.
- •Living in Ontario, Canada
排除标准
- •Contraindications to any of the study medications (NRT, cytisine, varenicline).
- •Actively using one of the study medications in the past 7 days.
- •Actively enrolled in another formal smoking cessation program.
- •Pregnant or breastfeeding individuals.
- •Unable to engage in follow-up for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French).
- •Other conditions deemed by the study team to interfere with participation or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).
研究组 & 干预措施
Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
Nicotine replacement therapy patch (titrated based on cigarettes consumed at baseline) plus short term gum or lozenge (as needed)
干预措施: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) (Drug)
Cytisine
Cytisine pills, standard dose
干预措施: Cytisine (Drug)
Varenicline (Champix)
Varenicline - standard dose
干预措施: Varenicline (Champix) (Drug)
结局指标
主要结局
Participant's Smoking Status
时间窗: 6 months
7-Day Point Prevalence of Smoking Cessation will be measured at 6 months. For those who report they have quit smoking, this will be biochemically verified through a salivary cotinine test.
次要结局
- Participant's Smoking Status at follow-up(1, 3, and 12 months)
- Number of quit attempts made by participant(6, and 12 months)
- Participant's level of nicotine dependance(6, and 12 months)
- Participant's heaviness of smoking score(6, and 12 months)
- Participant's adherence to the counselling program(12 months)
- Participant's adherence to study medication(6 months)
- Participant's response to smoking cessation quality of life questionnaire(Baseline, 6 and 12 months)
- Participant's response to the Patient Health Questionnaire (PHQ-9)(Baseline, 6 and 12 months)
- Participant's response to the General Anxiety Disorder Questionnaire (GAD-7)(Baseline, 6 and 12 months)