Randomized, Two Arm Parallel, Clinical Trial to Compare Effectiveness of Different Tobacco Harm Reduction Products in General Adult Population in Low Middle Income Countries
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Point-prevalence abstinence
研究概览
简要总结
The study is a two-arm, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258 smokers from general adult population. Participants who meet the eligibility criteria and give their informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counselling (2) Nicotine patches (21mg) with individual counselling. Eligible participants must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence. All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study.
详细描述
This is a two-arm, parallel randomized controlled trial with a 12 weeks treatment duration and long-term 52 weeks follow-up. Outpatient, and walk-in clinics, and advertising will be used to recruit participants from the general population. Individual counselling regarding smoking cessation will be provided to the participants using EC as well as nicotine patches. Participants included must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence (exhaled carbon monoxide levels above ten ppm regarded as indicator of current smoking). All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study. Information about self-reported smoking, usage of EC and nicotine patches, use of other smoking cessation therapy and side effects will be gathered at all follow-up calls and visits.
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
- None
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
- •Both genders of legal age allowed for smoking as per country law
- •Smoked at least 10 cigarettes a day for the past one year
- •Exhaled breath CO (eCO) level > 10 ppm
- •Wish to quit smoking
- •Able to conform with all study procedures
- •Have a mobile phone
- •Expected to be available for follow up will be enrolled as study participants
排除标准
- •Pregnant and breastfeeding women
- •Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline)
- •Having any contraindications to products such as cardiovascular history
- •Suffering from a major illness with prognosis of less than 1 year
研究组 & 干预措施
Study Arm A: Electronic Cigarettes (18mg/ml)
Participants randomized to study arm A will be provided a free e-cigarette and sufficient nicotine cartridges (18 mg/ml) supply to last till next in person visit. Participants will be instructed to use the device ad libitum one week before their quit day to familiarize themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the e-cigarette exclusively for the next 12 weeks. Smokers often take 10 to 15 puffs over the course of 5 to 8 minutes, repeating this pattern with each cigarette. On the other hand, users of EC may periodically use it throughout the day, and they may or may not take their puffs like those of traditional cigarettes
干预措施: E-Cigarette (Device)
Study Arm B: 21 mg nicotine patches
Participants randomized to study arm B will be provided 21 mg nicotine patches supply to last till next in person visit. Participants will use the nicotine patch daily for one week before their quit day to familiarize themselves with its use. On their designated quit day they will stop smoking and use nicotine patches daily for the next 12 weeks. Usually a full-strength patch (15-22 mg of nicotine) daily for four weeks is suggested for use in majority of the smokers, followed by a lower strength patch (5-14 mg of nicotine) for an additional four weeks, depending on their body size and smoking habits
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Point-prevalence abstinence
时间窗: 12 weeks
Number of participants self-reported abstinence in the past week, with biochemical validation using exhaled CO measurements of ≤ 10 ppm.
次要结局
- Seven-day point prevalence(7 days for 12 weeks)
- Use of tobacco combustible cigarettes(12 weeks)
- Perception of the product(12 weeks)
- Adverse events(12 weeks)
- Physical signs and symptoms associated with withdrawal(52 weeks)
研究者
Dr. Madeeha Malik
Principal Investigator
Foundation for a Smoke Free World INC