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

Trial Summary

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 moist snuff safe for human use?

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 substances like tobacco-specific nitrosamines, which are known carcinogens (cancer-causing agents). ^{1 2 3 4 5}

How does the treatment of smokeless tobacco use differ from other treatments for tobacco-related cancer?

This treatment is unique because it involves the use of moist snuff, a form of smokeless tobacco, which is typically associated with causing cancer rather than treating it. Unlike other treatments that aim to reduce or eliminate tobacco use, this approach may focus on understanding the effects of moist snuff on cancer development, which is not a standard treatment method for tobacco-related cancer. ^{3 4 5 6 7}

What is the purpose of this trial?

This clinical trial tests the effects of tobacco cut and nicotine form on the abuse liability in participants who use moist snuff (smokeless tobacco \[SLT\]). Two features of moist snuff that are key targets of manipulation from the tobacco industry and drivers of its addiction potential are length of tobacco cut (long versus fine) and nicotine form (low versus high levels of nicotine in the free-base form). Finer tobacco cuts and higher levels of free-base nicotine (FBN) result in faster, greater nicotine delivery. Researchers want to gain information on how certain characteristics of moist snuff affect how long people use it, how it delivers nicotine, or how much people like it. This clinical trial may provide justifications for local, state, or federal regulations aimed at reducing the appeal and addictiveness of moist snuff.

Research Team

Brittney L. Keller-Hamilton

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Surveillance of moist snuff: total nicotine, moisture, pH, un-ionized nicotine, and tobacco-specific nitrosamines. [2019]

3. United States 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]

4. England pubmed.ncbi.nlm.nih.gov

Levels of nicotine in dust from homes of smokeless tobacco users. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Smokeless tobacco use and cancer of the upper respiratory tract. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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