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

NCT07755891 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Cigarette Smoking
  • Nicotine Dependence

Interventions

OTHER

SPECTRUM cigarettes

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.

OTHER

SPECTRUM cigarettes

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.

Sponsors & Collaborators

  • Sung-il Cho

    lead OTHER

Principal Investigators

  • Sung-il Cho, MD, ScD · Seoul National University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2027-05-31
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755891 on ClinicalTrials.gov