Nicotine Pouches for Preventing Tobacco-Related Cancer

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Chantix, Wellbutrin

Disqualifiers: Pregnancy, Cardiac events, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

71 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.

What data supports the effectiveness of the treatment Nicotine Oral Pouch, Smokeless Tobacco for preventing tobacco-related cancer?

Research shows that tobacco use is a major cause of cancer, and quitting smoking can improve cancer treatment outcomes and survival. Integrating tobacco treatment into cancer care, like using nicotine pouches, has been shown to be feasible and effective in helping patients quit smoking, which may reduce cancer risk. ^{1 2 3 4 5}

Is it safe to use nicotine pouches?

Research suggests that nicotine pouches may expose users to fewer harmful substances compared to smoking cigarettes, indicating a potentially safer profile. However, there is still limited independent data on their overall safety and long-term effects. ^{6 7 8 9 10}

How is the drug Nicotine Oral Pouch different from other treatments for preventing tobacco-related cancer?

Nicotine Oral Pouches are unique because they are tobacco-free and deliver nicotine by being placed between the lip and gum, offering a potentially less harmful alternative to traditional tobacco products. Unlike other treatments, they are available in various flavors and are designed to reduce the harm associated with tobacco use. ^{7 11 12 13 14}

What is the purpose of this trial?

This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.

Research Team

Brittney L. Keller-Hamilton

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 21 who live in Ohio Appalachia or nearby rural areas, use smokeless tobacco daily, and can abstain from all tobacco, nicotine, and marijuana before clinic visits. It's not for those with certain lung diseases, oral cancers, recent heart issues, pregnant/breastfeeding women, people planning to quit tobacco soon or using cessation aids.

Inclusion Criteria

I am 21 years old or older.

Reside in an Ohio Appalachian county or surrounding rural area

Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits

Exclusion Criteria

I have not had heart problems, uncontrolled high blood pressure, significant mouth issues, or severe shortness of breath in the last year.

Use tobacco products other than smokeless tobacco more than 10 days per month

Unstable or significant psychiatric conditions for more than 1 year (past and stable conditions will be allowed)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive different brands of nicotine pouches and their usual smokeless tobacco over three study visits, with blood collection and IV line insertion

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nicotine Oral Pouch
• Smokeless Tobacco

Trial Overview The study looks at the impact of nicotine pouches as a substitute for smokeless tobacco among residents of rural Ohio. Participants will collect biospecimens and answer questionnaires to help researchers understand how these products are adopted and their public health implications.

Participant Groups

Group I: Arm VI (Rogue NP, ZYN NP, usual SLT) Experimental Treatment 4 Interventions

Participants receive Rogue brand nicotine patch at study visit 1, ZYN brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study

Group II: Arm V (Rogue NP, usual SLT, ZYN NP) Experimental Treatment 4 Interventions

Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group III: Arm IV (ZYN NP, Rogue NP, usual SLT) Experimental Treatment 4 Interventions

Participants receive ZYN brand nicotine patch at study visit 1, Rogue brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group IV: Arm III (ZYN NP, usual SLT, Rogue NP) Experimental Treatment 4 Interventions

Participants receive ZYN brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group V: Arm II (usual SLT, Rogue NP, ZYN NP) Experimental Treatment 4 Interventions

Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group VI: Arm I (usual SLT, ZYN NP, Rogue NP) Experimental Treatment 4 Interventions

Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Findings from Research

A study involving 246 clinicians and 2,146 cancer patients showed that electronic health record (EHR) nudges aimed at clinicians significantly increased tobacco use treatment (TUT) referrals and prescriptions, with TUT penetration rising from 13.5% in usual care to 35.6% with clinician nudges.

The results indicate that while clinician nudges were effective, adding patient nudges did not further enhance TUT engagement, suggesting that targeting clinicians may be the most effective strategy for improving tobacco treatment in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke. Jenssen, BP., Schnoll, R., Beidas, RS., et al.[2023]

Tobacco use is a major preventable cause of cancer, linked to 30% of all cancer-related deaths in the U.S., and negatively impacts cancer treatment efficacy, quality of life, and survival outcomes.

The authors recommend that smoking history and status be systematically collected in all oncology clinical trials to better understand its effects on treatment outcomes and to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking, the missing drug interaction in clinical trials: ignoring the obvious. Gritz, ER., Dresler, C., Sarna, L.[2015]

The Cancer Center Cessation Initiative (C3I) has successfully expanded access to tobacco cessation programs at 52 NCI-designated Cancer Centers, ensuring that cancer patients can receive evidence-based support for quitting tobacco.

Despite the increased availability of these services, patient utilization remains low, prompting the formation of the C3I Implementation Science Working Group to develop strategies that enhance the adoption of tobacco treatment interventions in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation Science to Improve Tobacco Cessation Services in Oncology Care. [2022]

Approximately 46.6% of U.S. adult tobacco users are aware of nicotine pouches, but only 3.0% currently use them, indicating a gap between awareness and actual use.

Younger individuals and those who use smokeless tobacco are more likely to have used nicotine pouches, and having positive beliefs about NPs correlates with increased likelihood of use, highlighting the need for ongoing monitoring of public perceptions and usage trends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine Pouch: Awareness, Beliefs, Use, and Susceptibility among Current Tobacco Users in the United States, 2021. Sparrock, LS., Phan, L., Chen-Sankey, J., et al.[2023]

Nicotine pouches, a new product category, are being marketed with minimal research and regulatory oversight, highlighting significant gaps in understanding their potential harms and benefits.

The commentary suggests a comprehensive assessment approach to inform regulatory policies, aiming to enhance public health outcomes while reducing unintended negative effects associated with nicotine pouch use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool? Patwardhan, S., Fagerström, K.[2023]

In a study involving 30 adult smokers, 6-mg oral nicotine pouches (ONPs) delivered more nicotine to the bloodstream at 30 minutes compared to both 3-mg ONPs and cigarettes, suggesting they can be effective for nicotine delivery.

However, neither concentration of ONPs provided as much relief from cravings at 5 minutes as cigarettes did, indicating that while ONPs may be less harmful, they might not satisfy cravings as effectively, which could influence their potential for misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study. Keller-Hamilton, B., Alalwan, MA., Curran, H., et al.[2023]

Participants in focus groups perceived oral nicotine pouches (ONPs) as having similar or lower risks compared to traditional cigarettes and smokeless tobacco, although they acknowledged potential gastrointestinal and cardiovascular risks.

ONPs were viewed as situational substitutes rather than complete replacements for cigarettes and smokeless tobacco, which could lead to increased overall nicotine use in certain populations, particularly in Appalachia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of oral nicotine pouches & their marketing among Ohio Appalachia smokers and smokeless tobacco users. Long, L., Alalwan, MA., Keller-Hamilton, B., et al.[2023]

Exclusive users of Velo nicotine pouches showed significantly lower levels of harmful biomarkers compared to smokers, including a 91% reduction in total NNAL and a 46% reduction in carbon monoxide levels, indicating a lower risk of smoking-related diseases.

Velo users had higher total nicotine equivalents than smokers, but overall exposure to tobacco toxicants was much lower, suggesting that Velo pouches may be a safer alternative for nicotine delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. Azzopardi, D., Haswell, LE., Frosina, J., et al.[2023]

A study analyzing 653 Reddit posts about oral nicotine pouches revealed that users predominantly shared positive experiences and product information, indicating a favorable public perception of these tobacco-free products.

The discussions also highlighted a significant interest in quitting traditional nicotine products, with 12.7% of posts focused on using oral nicotine pouches as a cessation tool, suggesting potential for these pouches in harm reduction strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Oral Nicotine Pouches on Reddit: Observational Study. Shao, Y., Zou, J., Xie, Z., et al.[2022]

Nicotine pouches are gaining popularity in the UK as tobacco-free products that deliver nicotine when placed between the lip and gum.

The article discusses the composition, legality, and usage patterns of nicotine pouches, as well as potential oral and general health effects associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine pouches: a review for the dental team. M Jackson, J., Weke, A., Holliday, R.[2023]

The study analyzed nicotine pouch regulations across 67 countries, revealing significant differences in how these products are classified and regulated, particularly regarding synthetic nicotine.

Only 34 countries have regulations for nicotine pouches, with 23 of those including synthetic nicotine in their policies, highlighting a need for more consistent regulatory frameworks to ensure safety and control over these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine pouches: a summary of regulatory approaches across 67 countries. Duren, M., Atella, L., Welding, K., et al.[2023]

Nicotine pouch use in Great Britain is currently rare, with a prevalence of only 0.26% among adults, but it has doubled from November 2020 to October 2021, indicating a growing interest in these products.

The use of nicotine pouches is significantly more common among men, current smokers, and users of other nicotine products like e-cigarettes and nicotine replacement therapies, suggesting that these pouches may appeal more to those already familiar with nicotine consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco-free Nicotine Pouch Use in Great Britain: A Representative Population Survey 2020-2021. Tattan-Birch, H., Jackson, SE., Dockrell, M., et al.[2022]

References

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

Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke. [2023]

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

Integrating tobacco treatment into thoracic oncology settings: Lessons learned. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Hospital-based tobacco treatment for inpatients with a history of cancer. [2023]

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

Smoking, the missing drug interaction in clinical trials: ignoring the obvious. [2015]

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

Implementation Science to Improve Tobacco Cessation Services in Oncology Care. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotine Pouch: Awareness, Beliefs, Use, and Susceptibility among Current Tobacco Users in the United States, 2021. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool? [2023]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study. [2023]

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

Perceptions of oral nicotine pouches & their marketing among Ohio Appalachia smokers and smokeless tobacco users. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Perceptions of Oral Nicotine Pouches on Reddit: Observational Study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Nicotine pouches: a review for the dental team. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Nicotine pouches: a summary of regulatory approaches across 67 countries. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Tobacco-free Nicotine Pouch Use in Great Britain: A Representative Population Survey 2020-2021. [2022]