Moist Snuff Effects for Tobacco-Related Cancer

Recruiting at 1 trial location

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Chantix, Wellbutrin

Disqualifiers: Pregnancy, Psychiatric conditions, Cardiac event, others

Compensation: Varies

Number of Visits: 5

Duration: 5 visits

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different types of moist snuff, a form of smokeless tobacco, affect its addictiveness and usage. Researchers focus on how the tobacco cut (long vs. fine) and the level of nicotine in its free-base form (low vs. high) influence user preference and the speed of nicotine delivery. Participants will use different types of moist snuff, and results may help shape regulations to make these products less appealing and addictive. The trial seeks adults who have used moist snuff daily for at least six months and live in Ohio's Appalachian counties or nearby rural areas. As an unphased trial, this study offers participants a chance to contribute to important research that could lead to healthier regulations.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must abstain from all tobacco, nicotine, and marijuana for 12 hours before clinic visits.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using smokeless tobacco, such as moist snuff, harms health. It contains nicotine and other dangerous chemicals, which can cause health problems. No safe amount of smokeless tobacco exists. It can lead to cancers in areas such as the mouth, pancreas, and esophagus.

Some studies suggest that low free-base nicotine (FBN) moist snuff contains fewer harmful chemicals than regular snuff. However, it still contains nicotine, which is addictive, and other cancer-causing substances.

High FBN moist snuff delivers nicotine more quickly and in larger amounts, potentially increasing its addictiveness. The National Institutes of Health has identified smokeless tobacco as a human carcinogen, meaning it can cause cancer in people.

In summary, all types of moist snuff pose safety concerns. They can lead to health issues like cancer and addiction due to nicotine. Despite differences in nicotine levels or tobacco cut, the risks remain significant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are curious about the effects of different types of smokeless tobacco on tobacco-related cancer risk. Unlike typical tobacco cessation treatments, which focus on quitting smoking or using nicotine replacement therapies, this study explores the impact of varying nicotine content and cut sizes in moist snuff. The trial aims to uncover how these variations may influence cancer risk factors, like blood nicotine levels and carbon monoxide exposure. By comparing low and high nicotine content and different cut sizes, researchers hope to better understand the potential harm or safety of these products. This could lead to more informed public health guidelines and tobacco regulation.

What evidence suggests that this trial's treatments could be effective for tobacco-related cancer?

This trial will compare different types of smokeless tobacco use, including low FBN long cut, high FBN fine cut, and participants' usual brand, to assess their effects on health. Studies have shown that smokeless tobacco, such as moist snuff, contains harmful chemicals that can cause serious health problems, including cancer in the mouth and pancreas. Research indicates that tobacco preparation affects how quickly nicotine enters the body. For instance, tobacco cut into smaller pieces with higher levels of a certain type of nicotine can deliver nicotine faster, increasing its addictiveness. Some studies have linked smokeless tobacco use to a higher risk of cancer in the mouth and pancreas. Overall, evidence suggests significant health risks are associated with using smokeless tobacco. ^{1 6 7 8 9}

Who Is on the Research Team?

Brittney L. Keller-Hamilton

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who use moist snuff, a type of smokeless tobacco. It's designed to understand how the cut of the tobacco and levels of nicotine affect its addictive potential. The study aims to inform regulations that could reduce the appeal and addictiveness of such products.

Inclusion Criteria

I have been using moist snuff daily for at least 6 months.

I am 21 years old or older.

Exclusive SLT user reporting every day or some days use per week at time of enrollment

Exclusion Criteria

Pregnant, planning to become pregnant, or breastfeeding (will be verified with a urine pregnancy test at the first session visit)

I have had a heart problem like chest pain or high blood pressure in the last 3 months.

I have severe gum or mouth sores.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 5 study visits in a randomized order to use different types of moist snuff and undergo blood sample collection and carbon monoxide testing

5 visits

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smokeless Tobacco Use

Trial Overview The study investigates two main factors: the length of tobacco cut (long vs fine) and nicotine form (low vs high free-base nicotine). Participants will be observed for their usage patterns, nicotine delivery speed, and product preference.

How Is the Trial Designed?

Group I: Prevention (Smokeless tobacco use: Low FBN Long Cut) Active Control 4 Interventions

Participants use low FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Group II: Prevention (Smokeless tobacco use: High FBN Fine Cut) Active Control 4 Interventions

Participants use high FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Group III: Prevention (Smokeless tobacco use: Low FBN Fine Cut) Active Control 4 Interventions

Participants use low FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Group IV: Prevention (Smokeless tobacco use: High FBN Long Cut) Active Control 4 Interventions

Participants use high FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Group V: Prevention (Smokeless tobacco use: Usual Brand) Placebo Group 4 Interventions

Participants use their usual brand of moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A review of 21 studies on smokeless tobacco use shows that moist snuff and chewing tobacco have minimal cancer risks for oral and upper respiratory cancers, with relative risks between 0.6 and 1.7.

In contrast, dry snuff is associated with significantly higher cancer risks, ranging from 4 to 13, indicating that the type of smokeless tobacco product used greatly influences cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokeless tobacco use and cancer of the upper respiratory tract. Rodu, B., Cole, P.[2022]

In a study of 279,897 male Swedish construction workers, snus use was found to significantly increase the risk of pancreatic cancer among never-smokers, with a relative risk of 2.0 compared to non-tobacco users.

However, the study did not find any significant association between snus use and the incidence of oral or lung cancers, suggesting that while snus may pose a risk for pancreatic cancer, it may not have the same impact on other cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral use of Swedish moist snuff (snus) and risk for cancer of the mouth, lung, and pancreas in male construction workers: a retrospective cohort study. Luo, J., Ye, W., Zendehdel, K., et al.[2022]

Moist snuff is classified as a human carcinogen and toxin, indicating significant health risks despite being perceived as a safer alternative to cigarette smoking.

The promotion of moist snuff has not led to a consistent reduction in smoking rates, and its role in smoking cessation is minimal, suggesting that its use as a harm-reduction strategy is not well-supported by evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiologic perspectives on smokeless tobacco marketing and population harm. Tomar, SL.[2022]

Smokeless tobacco products, such as moist snuff and chewing tobacco, are linked to serious health risks including oral cancer, precancerous lesions, cardiovascular diseases, and nicotine addiction, particularly among young male high school students in the U.S.

Analysis of six moist snuff products revealed significant variations in pH, nicotine content, and moisture levels, which can influence the nicotine dose delivered to users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of nicotine, pH, and moisture content of six U.S. commercial moist snuff products--Florida, January-February 1999. [2015]

A study of 40 top-selling moist snuff brands revealed significant variability in the levels of un-ionized nicotine (up to 500-fold) and carcinogenic tobacco-specific nitrosamines (TSNAs, up to 18-fold), indicating that some products may pose greater health risks than others.

The findings suggest that product characteristics, such as packaging and moisture content, influence nicotine absorption and carcinogen levels, raising concerns about the marketing of smokeless tobacco as a safer alternative to smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance of moist snuff: total nicotine, moisture, pH, un-ionized nicotine, and tobacco-specific nitrosamines. Richter, P., Hodge, K., Stanfill, S., et al.[2019]

Children living in homes with smokeless tobacco users are exposed to significantly higher levels of nicotine, with concentrations 21 times greater than in tobacco-free homes, indicating a serious risk of indirect exposure.

The study suggests that nicotine in these homes likely comes from tobacco being spilled or expectorated, highlighting the need for awareness about the risks of smokeless tobacco use around children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levels of nicotine in dust from homes of smokeless tobacco users. Whitehead, TP., Metayer, C., Park, JS., et al.[2021]

The use of moist snuff and other smokeless tobacco products in the U.S. nearly tripled from 1972 to 1991, indicating a significant increase in consumption during that period.

Long-term use of smokeless tobacco is linked to nicotine addiction and a heightened risk of oral cancer, raising concerns about the potential for increased incidence among young users who continue to use these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of smokeless tobacco among adults--United States, 1991. [2008]

Citations

1. withpower.com withpower.com/trial/phase-tobacco-related-carcinoma-2-2024-2a662

Moist Snuff Effects for Tobacco-Related Cancer Moist snuff, a type of smokeless tobacco, is not considered safe as it can cause oral cancer, precancerous lesions, and nicotine addiction. It contains harmful ...

2. reporter.nih.gov reporter.nih.gov/search/55gLqWYLakq1awbEP_C4vQ/project-details/11005762

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Tobacco-Related%20Carcinoma%22

San Mateo Clinical Trials Finer tobacco cuts and higher levels of free-base nicotine (FBN) result in faster, greater nicotine delivery. Researchers want to gain information on how ...

4. tobaccofreekids.org tobaccofreekids.org/us-resources/fact-sheet/health-harms-from-smokeless-tobacco-use

HEALTH HARMS FROM SMOKELESS TOBACCO USE Smokeless tobacco contains at least 28 cancer-causing chemicals and causes oral, pancreatic and esophageal cancer. Use of smokeless tobacco is also associated ...

5. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-021-00557-6

The health impact of smokeless tobacco products US studies showed mixed results for mortality (raised overall, CHD, cancer and smoking-related cancer mortality; no excess risk of respiratory ...

6. reporter.nih.gov reporter.nih.gov/project-details/11005762

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12291100/

Examining the role of freebase nicotine in the harm ... Because ONPs contain fewer toxicants than moist snuff and may serve as a reduced harm alternative for smokeless tobacco, we compared how the FBN ...

8. researchgate.net researchgate.net/publication/23455289_Surveillance_of_moist_snuff_Total_nicotine_moisture_pH_un-ionized_nicotine_and_tobacco-specific_nitrosamines

Surveillance of moist snuff: Total nicotine, moisture, pH, un- ... The National Toxicology Program of the National Institutes of Health has classified smokeless tobacco as a human carcinogen. Tobacco-specific ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0273230010001558

Free-base nicotine in tobacco products. Part II. ... The data we obtained on the STP samples are shown in Table 1. The samples are grouped by product type with the long-cut and fine-cut moist snuff products ...