Study reveals hidden cancer risk in smokeless tobacco
NCT ID NCT03998735
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 Hide 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);
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Smokeless tobacco are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.