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

Sponsor
Sung-il Cho
Study ID
NCT07755891
Status
Not Yet Recruiting

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Conditions

  • Cigarette Smoking
  • Nicotine Dependence

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SPECTRUM cigarettes — OTHER
    NRC102 non-menthol SPECTRUM research cigarettes with very low nicotine content (VLNC), containing approximately 0.4 mg nicotine per gram of tobacco. Final product specifications will follow documentation from the National Institute on Drug Abuse (NIDA) and RTI International for the lot used.
  • SPECTRUM cigarettes — OTHER
    NRC600 SPECTRUM research cigarettes with normal nicotine content (NNC), containing approximately 17.36 mg nicotine per gram of tobacco. Final product specifications will follow documentation from the National Institute on Drug Abuse (NIDA) and RTI International for the lot used.

Study Details

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 Dates

First listed
Aug 10, 2026
Start date
Jan 31, 2027
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Very Low Nicotine Content (VLNC) Cigarettes
  • Active Comparator: Normal Nicotine Content (NNC) Cigarettes

Primary Outcome Measure

Mean number of cigarettes smoked per day during the 7 days preceding the Week 14 endline visit [ Time Frame: 7 days preceding Week 14 endline visit ]

Central Contacts

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