An interventional study of SPECTRUM cigarettes and SPECTRUM cigarettes in Cigarette Smoking and Nicotine Dependence, sponsored by Sung-il Cho. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Sung-il Cho · Not applicable, Interventional, and Basic science
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:
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:
Up to approximately 350 individuals may be recruited and screened to obtain approximately 300 randomized participants.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 300 is above the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →This is the only study on the registry with Sung-il Cho as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: SPECTRUM cigarettes
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.
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.
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.
Time frame: 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.
Time frame: From randomization at Week 2 through the Week 14 endline visit (12 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and biweekly visits through Week 14
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for May 2027, 4 months later.
Of 184 non-industry interventional studies with no phase under Cigarette Smoking, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's planned 4 months is below that.
Counting every sponsor, half of 191 studies reached it within 20 months; a quarter within 9 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.