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Could a Nicotine-Free cigarette break the habit?

NCT ID NCT07755891

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether switching to cigarettes with very low nicotine content can reduce how much people smoke and their nicotine exposure. Adult daily smokers in South Korea will be randomly assigned to either very low nicotine or normal nicotine cigarettes for 12 weeks. Researchers will track smoking behavior, nicotine levels, cravings, and withdrawal symptoms to see if the low-nicotine option helps people smoke less.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Very low nicotine content (VLNC) cigarettes
What this could lead to
If effective, very low nicotine cigarettes could help smokers cut down or quit, reducing nicotine dependence and related health risks.
What could go wrong
The trial is early and may not show lasting changes in smoking behavior. Participants might compensate by smoking more or using other nicotine products.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Cigarette Smoking nicotine dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical Education Building, Seoul National University College of Medicine

    Seoul, 03080, South Korea

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