Effects of Very Low Nicotine Content Cigarettes Among Adults Who Smoke Daily in South Korea (NCT07755891) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Very Low Nicotine Content Cigarettes Among Adults Who Smoke Daily in South Korea
South Korea300 participantsStarted 2027-01
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean number of cigarettes smoked per day during the 7 days preceding the Week 14 endline visit
Timeframe: 7 days preceding Week 14 endline visit
2
Number of smoke-free days during the 12-week randomized intervention period
Timeframe: From randomization at Week 2 through the Week 14 endline visit (12 weeks)