Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Nicotine Mouth Spray for Tobacco Dependence in the Systemically Disadvantaged Population
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Quality of Life
研究概览
简要总结
Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco use rate has substantially gone down in the general population, significant differences exist between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the rest of the Canadian general population. This stark inequity in tobacco use translates into devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart disease and death. Canadians who are homeless or at-risk for homelessness die 25 years earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use related inequity - a novel approach is urgently needed. Despite commonly held dogma that People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led community-based action approach used in their PROMPT project has demonstrated that tobacco dependence strategies can be implemented with great success in this population. The majority of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all other drug use. Importantly, the investigators have demonstrated that it is possible to gain the trust and engagement of marginalized populations and that researchers can create a community space that is low-threshold, safe and non-judgmental. The investigators aim to compare two tobacco dependence management strategies in the homeless (or at-risk for homelessness) multi-drug use population in Ottawa and Toronto. They will use the same peer-led approach in PROMPT with community peer researchers with lived experience; with the hope that the cost-effective community based framework derived from this trial will serve as a template for interventions and treatments in community settings for chronic diseases such as obesity and diabetes.
详细描述
Aim: A 3-yr multi-centre, pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of Cytisine (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner-city population.
Background: Homelessness/at-risk for homelessness populations in Canada carry disproportionate burden of many diseases, mostly due to tobacco. With smoking rates at ~100% in some subpopulations as compared to 9-18% in the general population, tobacco inequity is translated into unequal morbidity and mortality (COPD, cancers, heart diseases). Tobacco use costs the Ontario economy ~$1.6 billion/year in healthcare costs. Smoking attributable hospitalization costs ~$38.2 million/year in Ottawa alone from 2008-10. The inner-city population in Canada dies ~25 years earlier than housed Canadians, largely due to tobacco. With negligible quit rates using conventional strategies, novel approaches to address tobacco inequity are urgently needed.
Cytisine is a naturally occurring alkaloid that has long been used as a tobacco dependence treatment and management aid in Eastern Europe. Health Canada has approved Cytisine as an over-the-counter health product, and the Canadian Agency for Drugs and Technologies in Health (CADTH) has determined Cytisine to be a cost-effective tobacco dependence treatment and management aid. Given its cost-effectiveness and affordability compared to nicotine replacement therapy, Cytisine may be more accessible and effective for marginalized populations. Cytisine will be made available to study participants as a Health Canada licensed natural health product.
Study Population: 200 Toronto and Ottawa inner city homeless/at-risk for homelessness participants using poly-substances.
Primary Patient-Oriented Outcome: To assess the impact of two pragmatic tobacco dependence strategies on changes in QOL and GAINSS score measured with the EQ-5D-5L; Secondary: i) To assess effectiveness of these two strategies with biochemically validated smoking abstinence at 13 and 26 weeks; ii) To assess effectiveness of these two strategies on conventional cigarette and/or e-cigarette consumption reduction and cessation at 13 and 26 weeks; iii) To assess self-reported reduction and cessation of other substance use at 13 and 26 weeks; and; iv) To describe the safety/tolerability of Cytisine or NRT SAEs, AEs, and drop-outs due to side effects, along with therapy adherence over 26 weeks; and, v) To compare lung function using oscillometry and spirometry, as well as self-efficacy at baseline, 13 weeks, and 26 weeks; Tertiary: i) To assess the cost-effectiveness of the pragmatic tobacco dependence strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research staff analyzing the data and members of the data and safety monitoring committee will be blinded to the treatment. allotment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Currently living in Ottawa or Toronto
- •Actively used tobacco and/or nicotine products (i.e., cigarettes, vape) in the past 7 days; 2) and want to use NRT or Cytisine
- •Identify as being low socioeconomic status, experiencing homelessness or at-risk for homelessness, and/or racialized
- •Available for in-person follow-ups for six months
排除标准
- •Consent declined (refusal from participant or decision maker)
- •Any person who is in or planning on accessing addictions treatment (in-patient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up
- •Currently or recently (in the past 30 days) enrolled in any other smoking cessation program or have used/is using any e-cigs (nicotine or non-nicotine) in the past 60 days
- •Terminal illness with a life expectancy of less than 3 months
研究组 & 干预措施
Nicotine Replacement Therapy (NRT)
Nicotine Replacement Therapy (NRT): nicotine mouth spray, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers
干预措施: Nicotine replacement therapy (NRT) (Drug)
Cytisine
Cytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day).
干预措施: Cytisine (Drug)
结局指标
主要结局
Overall Quality of Life
时间窗: 13 weeks
To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores)
次要结局
- Smoking Prevalence(26 weeks)
- Tobacco and e-cigarette (with nicotine) use(26 weeks)
- Substance use(26 weeks)
- Safety and tolerability of Cytisine or NRT(26 weeks)
- Lung function(26 weeks)