Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number of Participants With Smoking Cessation
研究概览
简要总结
This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.
详细描述
Before the baseline visit, a face to face screening (V0) for pre-eligibility checks will be conducted. Subjects will be asked to practice with the step test for 10-15 minand will be instructed how to collect and store their morning urine before bringing it to the hospital on their Baseline visit (V1). This study will consist of a baseline visit (V1) and 6 follow-up study visits (V2-V7). At baseline (V1), participants will be randomized in two separate study groups. The randomization sequence will be computer generated by using blocks size of 5, with an allocation ratio of 1:1 for each of the study products (IQOS, JustFog-EC). Subjects will use and familiarize with their allocated product, as per randomization. They will be trained and counseled on the use of their allocated study product; oral explanation and practical demonstration will be followed by product trial during which participants will also have the option to try and choose their preferred flavour (either from a selection of 3 e-liquids or 3 tobacco sticks, depending on the allocated arm). Participants randomized in the IQOS arm will receive one iQOS kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those randomized in the JustFog-EC arm of the study will receive one JustFog Starter Kit and a full 1 week supply of e-liquids of their choice (they will receive 4, 10 mls refill containers).Free products will be supplied at each subsequent visit throughout the study. No supply of tobacco stick or e-liquid will be given at week-12, but users will be offered to keep using their products to minimize the risk of relapsing back to cigarette smoking. A prospective evaluation of cigarette consumption, adoption rates, acceptability and tolerability will be recorded throughout the study.
Visit 2 (V2):This will be scheduled 1 week after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured and product use recorded. Full 1 week supply of the chosen product will be provided.
Visit 3 (V3):This will be scheduled 2 weeks after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured and product use recorded. Participants will be instructed on how to collect and store their second urine sample before bringing it to the hospital at V4. Full 2 weeks supply of the chosen product will be provided.
Visit 4 (V4):This will be scheduled 4 weeks after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured, questionnaires completed and product use recorded. Step test will be carried out. Second urine sample will be collected, aliquotted and stored. Full 4 weeks supply of the chosen product will be provided.
Visit 5 (V5):This will be scheduled 8 weeks after V1 (with a tolerance of +/- 7 days). Cigarette/day, eCO, AEs, BP, HR will be measured, questionnaires completed and product use recorded. Full 4 weeks supply of the chosen product will be provided.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- •Able to comply with the study procedures
- •Male or female healthy smokers aged ≥19
- •Smoking at least 10 cigarettes a day
- •Smoking for at least one year
- •Not currently attempting to quit smoking or wishing to do so in the next 30 days (this will be verified at screening by the answer ''NO'' to both questions ''Do you intend to quit in the next 30 days?'' and ''Are you interested in taking part in one of our smoking cessation programs?'')
- •Female smokers not planning to become pregnant are using an acceptable form of contraception.
排除标准
- •The presence of any of the following will exclude a subject from study enrolment:
- •Use of smokeless tobacco, or any other tobacco products (including e-cigarettes, cigars, chewing tobacco, snus, etc.) within the last 3 months, at baseline and during the whole study.
- •Use of nicotine replacement therapy or other smoking cessation therapies within the last 3 months and at baseline.
- •Self-reported pregnancy, planned pregnancy or breastfeeding.
- •Tobacco industry employees and 1st degree relatives will be excluded in order to safeguard independence of the study
结局指标
主要结局
Number of Participants With Smoking Cessation
时间窗: 12 WEEK
to compare the efficacy of HTP and EC, in terms of quit rates at week 12, by self-reporting abstinence from classic cigarette \[validated by an Exhaled breath Carbon monoxide (eCO) measurement ≤10ppm)\]
次要结局
- Acceptability(Week 12)
- Changes in Biomarkers of Biological Effects (BoBE)(Week 12)
- Adoption Rate(Week 12)
- Number of Participants With Product-related Adverse Events(Week 12)
- Number of Participants Smoking Reduction(Week 12)
- Reliability(Baseline visit, Week 12)
研究者
Enrico Gian Maria Mondati
Researcher of Internal Medicine
University of Catania