Cigarette SmokingNCT07755891
Effects of Very Low Nicotine Content Cigarettes Among Adults Who Smoke Daily in South Korea
A study testing SPECTRUM cigarettes in people with Cigarette Smoking and Nicotine Dependence, run by Sung-il Cho at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Nicotine Dependence
- What is being tested?
- SPECTRUM cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2027to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Medical Education Building, Seoul National University College of Medicine
Seoul, 03080
Jaeyoung Ha, +82-10-3164-0339, snu.tobaccoendgame@gmail.com
Doyoon Kim, doyoonee1023@snu.ac.kr
About this study
Official title: Effects of Very Low Nicotine Content Cigarettes: A Randomized Controlled Trial Integrating Biological and Behavioral Pathways Among Adults Who Smoke Daily in South Korea
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?
Read more
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
- Being tested
- SPECTRUM cigarettes
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECTRUM cigarettesOther
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 cigarettesOther
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 group | Role | What they receive |
|---|---|---|
| Very Low Nicotine Content (VLNC) Cigarettes | Experimental | Not described Receives: Other: SPECTRUM cigarettes |
| Normal Nicotine Content (NNC) Cigarettes | Active comparator | Not described Receives: Other: SPECTRUM cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of cigarettes smoked per day during the 7 days preceding the 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.
Measured: 7 days preceding Week 14 endline visit
Number of smoke-free days during the 12-week randomized intervention period
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.
Measured: From randomization at Week 2 through the Week 14 endline visit (12 weeks)
Secondary outcomes (3)
Change from Week 2 baseline in urinary cotinine concentration
Urinary cotinine concentration will be assessed as a biomarker of nicotine exposure. Change from the Week 2 baseline value will be evaluated at Weeks 4, 8, 12, and 14. Because urinary cotinine concentrations are expected to be right-skewed, values may be log-transformed for analysis, and treatment effects may be reported as geometric mean ratios and corresponding percent differences between treatment groups.
Measured: Week 2 baseline; Weeks 4, 8, 12, and 14
Change from baseline in Fagerström Test for Nicotine Dependence total score
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). FTND total scores will be collected at baseline and at biweekly research-site visits during the randomized intervention period. Changes in total score over time and differences between the very low nicotine content and normal nicotine content cigarette groups will be evaluated.
Measured: Baseline and biweekly visits through Week 14
Change from baseline in Questionnaire of Smoking Urges-Brief score
Smoking craving will be assessed using the Questionnaire of Smoking Urges-Brief (QSU-Brief). Scores will be collected at baseline and at biweekly research-site visits during the randomized intervention period. Changes in craving over time and differences in mean craving scores between the very low nicotine content and normal nicotine content cigarette groups will be evaluated.
Measured: Baseline and biweekly visits through Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung-il Cho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sung-il Cho, Seoul National University
- Investigators
- Sung-il Cho, MD, ScD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755891
- Sponsor's protocol ID
- K-VLNC-RCT-00126
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share de-identified individual participant data has not yet been finalized. Data sharing will be considered after completion of the study and primary analyses, subject to review of participant consent, institutional policies, applicable ethical and legal requirements, and approval by the principal investigator and the relevant institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low Nicotine Content Cigarettes: A Randomized Controlled Trial Integrating Biological and Behavioral Pathways Among Adults Who Smoke Daily in South Korea
- ClinicalTrials.gov ID
- NCT07755891
- Acronym / sponsor ID
- K-VLNC-RCT-00126
- Conditions
- Cigarette Smoking, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sung-il ChoUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very Low Nicotine Content (VLNC) Cigarettes | Experimental | Other: SPECTRUM cigarettes |
| Normal Nicotine Content (NNC) Cigarettes | Active comparator | Other: SPECTRUM cigarettes |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECTRUM cigarettesNRC102 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 | Very Low Nicotine Content (VLNC) Cigarettes |
| SPECTRUM cigarettesNRC600 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. | Other | Normal Nicotine Content (NNC) Cigarettes |
Primary outcome
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
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
Time frame: 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.
3 secondary outcomes
Change from Week 2 baseline in urinary cotinine concentration
Time frame: Week 2 baseline; Weeks 4, 8, 12, and 14
Change from baseline in Fagerström Test for Nicotine Dependence total score
Time frame: Baseline and biweekly visits through Week 14
Change from baseline in Questionnaire of Smoking Urges-Brief score
Time frame: Baseline and biweekly visits through Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided. The plan to share de-identified individual participant data has not yet been finalized. Data sharing will be considered after completion of the study and primary analyses, subject to review of participant consent, institutional policies, applicable ethical and legal requirements, and approval by the principal investigator and the relevant institutional review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung-il Cho, MD, ScD principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECTRUM cigarettes in people with Cigarette Smoking and Nicotine Dependence, run by Sung-il Cho at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaeyoung Ha (+82-10-3164-0339, snu.tobaccoendgame@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.