ANSOS for Smokeless Tobacco Cessation

Overseen By Christine M Daley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lehigh University

Disqualifiers: Unstable phone number, Unable to attend Zoom

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

Compensation: Varies

Number of Visits: 4

384 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment ANSOS for smokeless tobacco cessation?

The ANSOS program, which is culturally tailored for American Indians, showed promise in a pilot test where 34% of participants who completed the program reported quitting smokeless tobacco, and 29.2% reduced their use. This suggests it could be an effective treatment for smokeless tobacco cessation. ^{1 2 3 4 5}

Is the ANSOS program safe for humans?

The available research does not provide specific safety data for the ANSOS program itself, but smokeless tobacco products are known to contain harmful chemicals and are associated with health risks like cancer and cardiovascular diseases. ^{1 6 7 8 9}

What makes the ANSOS treatment unique for smokeless tobacco cessation?

The ANSOS treatment is unique because it specifically targets smokeless tobacco users, a group for which there are no standard cessation treatments, and it may incorporate culturally tailored approaches to address the high prevalence of use among certain populations. ^{10 11 12 13 14}

What is the purpose of this trial?

This is a wait-list control trial to test for efficacy of the All Nations Snuff Out Smokeless (ANSOS) recreational tobacco cessation program in multi-tribal American Indian (AI) communities. Participants randomized to the control arm are provided with a Healthy Living educational intervention while they wait for the program to encourage them to remain engaged with the study team during the six-month waiting period. Participants from the ANSOS arm are offered the Healthy Living educational intervention after they complete the 6-month outcome measures.

Research Team

Christine M Daley, PhD

Principal Investigator

Lehigh University

Eligibility Criteria

This trial is for members of multi-tribal American Indian communities who want to quit using smokeless tobacco. There are no specific inclusion or exclusion criteria provided, but typically participants would need to be users of smokeless tobacco and willing to follow the study procedures.

Inclusion Criteria

I have a reliable phone number for study communications.

Willing to be followed for 12 months and participate in study activities

I can participate in Zoom sessions.

Exclusion Criteria

Cannot provide a stable phone number for 12 months for the purpose of the study

I cannot attend Zoom sessions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Wait-list Control

Participants in the control arm receive the Healthy Living educational intervention while waiting for 6 months

6 months

Group sessions and individual discussions

ANSOS Treatment

Participants receive the ANSOS program, including group support sessions, individual telephone counseling, and educational materials

6 months

4 group sessions (virtual), weekly individual calls

Follow-up

Participants are monitored for abstinence from smokeless tobacco use

6 months

Treatment Details

Interventions

• All Nations Snuff Out Smokeless

Trial Overview The trial is testing the 'All Nations Snuff Out Smokeless' (ANSOS) program against a 'Healthy Living' educational intervention. Participants are randomly placed in either the ANSOS program or put on a waitlist and given Healthy Living education first.

Participant Groups

Group I: Wait List Control - Healthy Living Experimental Treatment 2 Interventions

Participants randomized to this arm are provided with information about healthy living while they wait for their turn at the intervention arm. Participants learn about diet, exercise, and stress reduction. They receive the All Nations Snuff Out Smokeless intervention after a six-month waiting period.

Group II: All Nation Snuff Out Smokeless Experimental Treatment 2 Interventions

This is a culturally targeted smokeless tobacco cessation program developed for American Indian communities. It includes group sessions via Zoom, individual telephone counseling, and educational materials.

Who Is Running the Clinical Trial?

Lehigh University

Lead Sponsor

Trials

24

Recruited

6,800+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

The All Nations Snuff Out Smokeless (ANSOS) program was developed specifically for American Indians, who have the highest rates of smokeless tobacco use in the U.S., and showed a 68.8% retention rate with 33 out of 48 participants completing the program.

Among those who completed the program, 34% reported being abstinent from smokeless tobacco, and when accounting for those lost to follow-up, the overall cessation rate was 22.9%, indicating that the program may be effective and culturally appropriate for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing All Nations Snuff Out Smokeless (ANSOS): A Culturally Tailored Smokeless Tobacco Cessation Program for American Indians. Daley, CM., Lewis, C., Nazir, N., et al.[2022]

A preliminary study with 106 smokeless tobacco users showed that using tobacco-free snuff for 8 weeks led to significant reductions in tobacco use and harmful biomarkers, such as urinary cotinine and total NNAL, a carcinogen.

Participants using tobacco-free snuff had a higher success rate in achieving at least a 50% reduction in cotinine levels and total NNAL, as well as more quit attempts and longer abstinence durations compared to those who did not use snuff, suggesting it may help reduce health risks associated with smokeless tobacco.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokeless tobacco reduction: preliminary study of tobacco-free snuff versus no snuff. Hatsukami, DK., Ebbert, JO., Edmonds, A., et al.[2020]

In a large-scale trial with 1236 participants, providing free samples of low nitrosamine smokeless tobacco (snus) did not lead to increased smoking cessation, as participants in the snus group were less likely to make quit attempts compared to the control group.

The study found that only 16% of participants in the snus group used it regularly by the end of the sampling period, indicating minimal uptake, and overall, the use of snus did not improve smoking abstinence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. Carpenter, MJ., Wahlquist, AE., Burris, JL., et al.[2022]

In a study involving 649 smokers, both snus and nicotine lozenges showed similar smoking cessation rates, indicating that snus could be a viable alternative to traditional nicotine replacement therapies, although overall success rates were low.

Providing information about the reduced risks of snus compared to smoking did not influence its usage or improve cessation outcomes, suggesting that simply informing users may not be enough to enhance the effectiveness of smokeless tobacco as a cessation aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial to Compare Smoking Cessation Rates of Snus, With and Without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge. Nelson, PR., Chen, P., Battista, DR., et al.[2020]

Noncombusted oral tobacco products, like moist snuff, are being marketed as potentially safer alternatives to cigarette smoking due to lower levels of toxicants and moisture, but their actual health effects and safety are still uncertain.

There is a significant need for research on the health impacts of these products, as well as for manufacturing standards and regulations to ensure lower toxicant levels, to prevent potential harm from increased tobacco use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing smokeless tobacco products new tobacco-delivery systems. Hatsukami, DK., Ebbert, JO., Feuer, RM., et al.[2022]

A study of 43 U.S. smokeless tobacco products from 2006 and 2007 revealed varying levels of toxicants, with snus brands generally having lower concentrations of harmful substances like benzo[a]pyrene and tobacco-specific nitrosamines compared to other moist snuffs.

The toxicant profiles of commercial smokeless tobacco products have improved over the past 20-30 years, showing lower levels of harmful chemicals, which may be due to changes in manufacturing practices and product formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The chemical composition of smokeless tobacco: a survey of products sold in the United States in 2006 and 2007. Borgerding, MF., Bodnar, JA., Curtin, GM., et al.[2023]

Smokeless tobacco use is becoming increasingly popular among children and adolescents in Canada and other countries, raising concerns about addiction starting at a young age.

Chemical analysis shows that certain smokeless tobacco products, particularly moist snuff from the Northwest Territories, contain extremely high levels of cancer-causing tobacco-specific nitrosamines (TSNA), far exceeding safety limits set for other consumer products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokeless tobacco: a product for the new generation of tobacco users. Dipping and chewing in the Northwest Territories, Canada, and its global relevance. Peterson, JS., Barreto, LA., Brunnemann, KD.[2023]

Chronic exposure to smokeless tobacco products, including snuff and snus, significantly reduces levels of endothelial progenitor cells and various immune cells in mice, which could impair the body's ability to repair blood vessels and increase infection risk.

Exposure to these products also leads to increased levels of the pro-inflammatory cytokine TNFα, suggesting a potential link to vascular inflammation and a higher risk of developing cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Toxicity of Smokeless Tobacco Products in Mice. Malovichko, MV., Zeller, I., Krivokhizhina, TV., et al.[2020]

The FDA's approval of smokeless tobacco products highlights their increasing popularity, especially in low- and middle-income countries, and raises concerns about aggressive marketing strategies targeting youth and current smokers.

Smokeless tobacco is linked to serious health risks, including various cancers and cardiovascular diseases, and there is no strong evidence that it helps people quit smoking; instead, it may encourage cigarette smoking, particularly among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Requiring Graphic Warning Labels on Smokeless Tobacco Product Packages. Pakhale, S., Samet, J., Folan, P., et al.[2022]

The use of oral snuff has increased by 51.8% over the past 15 years, particularly among teenage and young adolescent males, while chewing tobacco consumption has declined by 30.6%.

Snuff is associated with a higher risk of oral cancers due to its elevated levels of carcinogens, particularly tobacco-specific N-nitrosamines (TSNAs), which are found in higher concentrations in leading snuff brands, making them more likely to induce nicotine dependence and cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical composition and carcinogenicity of smokeless tobacco. Hoffmann, D., Djordjevic, MV.[2017]

In a study of 1151 male military recruits in Northern Finland, 15.6% reported daily use of Swedish snuff (snus), with nearly half of these users also smoking cigarettes daily, indicating a high prevalence of dual tobacco use.

Dual users of snus and cigarettes were less likely to attempt quitting smoking compared to exclusive smokers, suggesting that snus use may complicate efforts to stop smoking rather than serve as a successful alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual use of cigarettes and Swedish snuff (snus) among young adults in Northern Finland. Hamari, AK., Toljamo, TI., Kinnula, VL., et al.[2013]

A review of 28 studies, including 5 randomized controlled trials, found no significant evidence that Swedish snus effectively promotes smoking cessation, although some observational studies suggested a potential association with increased quitting rates.

The overall evidence for snus as a smoking cessation aid is weak, and the authors recommend further high-quality research, suggesting that existing cessation aids may be more effective than snus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of smokeless tobacco for smoking cessation: a systematic review and meta-analysis. Stjepanović, D., Phartiyal, P., Leung, J., et al.[2023]

Smokeless tobacco use, particularly among male adolescents, is rising, with 8 to 36 percent of male high-school students reported as regular users, leading to serious health risks including oral-pharyngeal cancer and leukoplakia.

The carcinogenic effects of smokeless tobacco are likely due to high levels of nitrosamines, prompting policymakers to consider regulatory measures such as health warnings, advertising bans, and sales restrictions to minors to combat this growing public health issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reemergence of smokeless tobacco. Connolly, GN., Winn, DM., Hecht, SS., et al.[2023]

In a study of 6,287 boys in Stockholm County, Sweden, 71% of those who used oral snuff (OS) also smoked cigarettes, indicating that smokeless tobacco use does not replace cigarette smoking but rather coexists with it.

The likelihood of using oral snuff was significantly higher among boys who had experienced alcohol intoxication or illicit drug use, suggesting that smokeless tobacco use may be linked to a broader pattern of risk-taking behaviors and could increase the risk of nicotine addiction in vulnerable adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Between harm and dangers. Oral snuff use, cigarette smoking and problem behaviours in a survey of Swedish male adolescents. Galanti, MR., Wickholm, S., Gilljam, H.[2019]

References

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

Pilot Testing All Nations Snuff Out Smokeless (ANSOS): A Culturally Tailored Smokeless Tobacco Cessation Program for American Indians. [2022]

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

Smokeless tobacco reduction: preliminary study of tobacco-free snuff versus no snuff. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. [2022]

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

Randomized Trial to Compare Smoking Cessation Rates of Snus, With and Without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Changing smokeless tobacco products new tobacco-delivery systems. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The chemical composition of smokeless tobacco: a survey of products sold in the United States in 2006 and 2007. [2023]

7. Finland pubmed.ncbi.nlm.nih.gov

Smokeless tobacco: a product for the new generation of tobacco users. Dipping and chewing in the Northwest Territories, Canada, and its global relevance. [2023]

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

Systemic Toxicity of Smokeless Tobacco Products in Mice. [2020]

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

The Case for Requiring Graphic Warning Labels on Smokeless Tobacco Product Packages. [2022]

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

Chemical composition and carcinogenicity of smokeless tobacco. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Dual use of cigarettes and Swedish snuff (snus) among young adults in Northern Finland. [2013]

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

Efficacy of smokeless tobacco for smoking cessation: a systematic review and meta-analysis. [2023]

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

The reemergence of smokeless tobacco. [2023]

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

Between harm and dangers. Oral snuff use, cigarette smoking and problem behaviours in a survey of Swedish male adolescents. [2019]