Effects of Very Low Nicotine Content Cigarettes Among Adults Who Smoke Daily in South Korea

Starting soon · Not applicable

Conditions studied: Cigarette Smoking, Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT07755891

Run by

Sung-il Cho

People needed

300

Starts

2027-01-01

Expected to finish

2027-06-01

Last updated by the study team

2026-08-10

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Education Building, Seoul National University College of Medicine — Seoul, South Korea

Full record on ClinicalTrials.gov

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