Study reveals hidden cancer risk in smokeless tobacco

NCT ID NCT03998735

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study investigates how nornicotine, a chemical found in smokeless tobacco, can be converted inside the body into NNN, a known cancer-causing substance. Researchers will give 55 adult smokeless tobacco users herbal snuff with different levels of nornicotine and measure the NNN produced. The goal is to understand this process and inform future regulations to reduce cancer risk.

What this could mean

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

Active substance
Herbal snuff with added nornicotine
What this could lead to
If successful, this study could help regulators set limits on nornicotine in smokeless tobacco to reduce cancer risk for users.
What could go wrong
This is a small, early-phase study focused on measuring chemical changes, not on health outcomes. It may not directly lead to any new rules or 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 55 people

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

Started

Oct 2021

Expected to finish

Aug 2026

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

18 to 65 years

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: * Male or female adult smokeless tobacco users 18-65 years of age, using at least 3 tins of product per week for 6 months; * Used the same brand for \>80% of their smokeless tobacco use over the course of at least 6 months, and used this brand exclusively for at least two weeks prior to the eligibility screening; * Not smoking or using any other nicotine or tobacco product in the past 2 weeks (expired CO \< 6 ppm); * Participants are in good physical health (no unstable medical condition) and good general oral health as determined by the licensed medical professional; * Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse) as determined by the licensed medical professional; * Participants who are not taking any medications that affect relevant metabolic enzymes; * Women who are not pregnant or nursing or planning to become pregnant; * Participants have provided written informed consent to participate in the study. Exclusion Criteria: * Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional; * Vital signs out of range as determined by the licensed medical professional (participants failing for vital signs will be allowed to re-screen once): * Evident poor oral health (significant gum recession, dental caries, tooth loss) as determined by the general oral health status check; * Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional; * Regular smoking or tobacco use (e.g., greater than once a week) other than oral smokeless tobacco products; * Currently (within the past 2 weeks) using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);

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Conditions

The condition(s) this trial relates to.

Tobacco Use

As listed by the trial registrant

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

Contacts and locations

Locations

  • Masonic Cancer Center

    Minneapolis, Minnesota, 55411, United States

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