Effects of Very Low Nicotine Content Cigarettes: A Randomized Controlled Trial Integrating Biological and Behavioral Pathways Among Adults Who Smoke Daily in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean number of cigarettes smoked per day during the 7 days preceding the Week 14 endline visit
研究概览
简要总结
The goal of this clinical trial is to learn how switching to very low nicotine content (VLNC) cigarettes affects smoking behavior and nicotine exposure among adults in South Korea who smoke conventional cigarettes daily. The main questions it aims to answer are:
- Do participants assigned to VLNC cigarettes smoke fewer cigarettes per day during the 7 days before the Week 14 endline visit than those assigned to normal nicotine content (NNC) cigarettes?
- Do participants assigned to VLNC cigarettes have more smoke-free days during the 12-week randomized intervention period than those assigned to NNC cigarettes?
Researchers will compare participants assigned to VLNC cigarettes with those assigned to NNC cigarettes to evaluate differences in smoking behavior, nicotine exposure, dependence, craving, withdrawal symptoms, abstinence-related outcomes, use of other tobacco or nicotine products, product perceptions, policy support, and behavioral patterns assessed using ecological momentary assessment.
Participants will:
- Complete a 1-week baseline period while continuing to smoke their usual-brand cigarettes.
- Be randomly assigned to receive either VLNC or NNC SPECTRUM research cigarettes for 12 weeks.
- Attend scheduled study visits and complete questionnaires, daily surveys, and ecological momentary assessments.
- Provide urine samples for assessment of nicotine exposure and complete other study assessments related to smoking behavior and symptoms.
Up to approximately 350 individuals may be recruited and screened to obtain approximately 300 randomized participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 years or older.
- •Current daily smoker of at least 10 conventional cigarettes per day for the past 12 months. Concurrent heated tobacco product use is permitted only when the participant meets the conventional-cigarette criterion and is a conventional-cigarette-dominant user.
- •No intention to quit smoking within the next month.
- •Willingness to switch entirely to the assigned study cigarettes during the trial period.
- •Ability to understand written Korean and complete study procedures independently.
- •Ability to use a smartphone for EMA data collection.
- •Ability to provide written informed consent.
排除标准
- •Current regular use of electronic cigarettes (e-cigarettes).
- •Self-reported pregnancy, planning pregnancy during the study period, or breastfeeding; or positive pregnancy test at screening for participants who can become pregnant.
- •Current use of pharmacological smoking cessation aids, including varenicline, bupropion, or nicotine replacement therapy.
- •Serious psychiatric disorder that would interfere with study participation, such as psychosis or severe depression.
- •Any medical condition that contraindicates continued smoking, including prespecified safety thresholds such as systolic blood pressure of 160 mmHg or higher, heart rate of 105 beats/min or higher, or heart rate below 45 beats/min with symptoms.
- •Any other factor that may affect adherence or pose a health risk to the participant.
- •Inability to read and write sufficiently to complete study activities.
- •No reliable way for the research team to communicate with the participant by telephone or email.
- •Current participation in another tobacco- or nicotine-related research study.
- •Prior participation in a similar tobacco or nicotine intervention trial involving SPECTRUM research cigarettes or manipulation of cigarette nicotine content, if determined to affect eligibility.
研究组 & 干预措施
Very Low Nicotine Content (VLNC) Cigarettes
干预措施: SPECTRUM cigarettes (Other)
Normal Nicotine Content (NNC) Cigarettes
干预措施: SPECTRUM cigarettes (Other)
结局指标
主要结局
Mean number of cigarettes smoked per day during the 7 days preceding the Week 14 endline visit
时间窗: 7 days preceding Week 14 endline visit
Cigarette consumption will be assessed using brief online daily surveys, a 7-day Timeline Follow-Back questionnaire completed at the Week 14 endline visit, and returned cigarette butt counts. Daily cigarette consumption estimates from available measures will be summarized for each participant and averaged across the 7 days preceding the Week 14 endline visit. The outcome includes both study and non-study conventional cigarettes. Lower values indicate fewer cigarettes smoked per day.
Number of smoke-free days during the 12-week randomized intervention period
时间窗: From randomization at Week 2 through the Week 14 endline visit (12 weeks)
A smoke-free day is defined as a day on which the participant reports smoking no study or non-study conventional cigarettes. The outcome will be calculated by summing the number of days with zero cigarettes smoked per day during the 12-week randomized intervention period. The possible range is 0 to 84 days, with higher values indicating a greater number of smoke-free days.
次要结局
- Change from Week 2 baseline in urinary cotinine concentration(Week 2 baseline; Weeks 4, 8, 12, and 14)
- Change from baseline in Fagerström Test for Nicotine Dependence total score(Baseline and biweekly visits through Week 14)
- Change from baseline in Questionnaire of Smoking Urges-Brief score(Baseline and biweekly visits through Week 14)
研究者
Sung-il Cho
Professor, Principal Investigator
Seoul National University