Menthol Ban Impact on Tobacco Smoking

Recruiting in New Haven (>99 mi)

Overseen By Krysten Bold, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Smoking cessation, Psychiatric, Medical, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a serious psychiatric or medical condition, you may be excluded from participating.

What data supports the effectiveness of the treatment menthol ban in cigarettes?

Research suggests that banning menthol in cigarettes may help increase quitting rates among menthol smokers, as switching to non-menthol cigarettes could change smoking behavior. However, evidence is limited and mixed, with some studies indicating no significant difference in smoking habits between menthol and non-menthol cigarette users. ^{1 2 3 4 5}

Is the menthol ban in cigarettes safe for humans?

There is no specific safety data on the menthol ban itself, but mentholated cigarettes are considered at least as harmful as non-mentholated ones, suggesting that removing menthol may not introduce new safety concerns. ^{1 6 7 8 9}

How does the menthol ban treatment differ from other smoking cessation treatments?

The menthol ban treatment is unique because it targets the removal of menthol flavoring from cigarettes, which is believed to help increase quitting rates among menthol smokers by reducing the appeal of smoking. Unlike other smoking cessation treatments that may involve medications or behavioral therapies, this approach focuses on altering the product itself to discourage use. ^{1 3 10 11 12}

Research Team

Krysten Bold, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults over 21 who are in good health, currently smoke menthol cigarettes, and have used e-cigarettes before. They must be able to read English and provide consent. People seeking smoking cessation treatment or with serious medical/psychiatric conditions or drug use can't participate.

Inclusion Criteria

Currently smoking cigarettes

Willing to try e-cigarettes

I am in good overall health.

Exclusion Criteria

I am not taking any other drugs that are not allowed in this trial.

Seeking smoking cessation treatment

I have a serious mental or physical health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants have access to their usual menthol cigarettes

2 weeks

Treatment

Participants receive tobacco products based on their assigned group for 8 weeks

8 weeks

Follow-up

A follow-up survey at week 12 will assess tobacco use outcomes

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• menthol ban in cigarettes only
• total menthol ban

Trial Overview The study is examining the effects of a menthol ban in cigarettes on smokers' behavior by comparing two scenarios: one where only menthol cigarettes are banned, and another where all menthol tobacco products are banned. It aims to see if this influences people to switch to e-cigarettes.

Participant Groups

Group I: menthol ban in cigarettes only Experimental Treatment 1 Intervention

non-menthol cigarettes and menthol flavored e-cigarette available

Group II: menthol ban in both cigarettes and e-cigarettes Experimental Treatment 1 Intervention

non-menthol cigarettes and tobacco flavored e-cigarette available,

Group III: no menthol ban Active Control 1 Intervention

usual menthol cigarettes and menthol flavored e-cigarette available

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

African American menthol smokers who switched to non-menthol cigarettes smoked fewer cigarettes per day and reported lower withdrawal symptoms, suggesting a potential benefit in smoking behavior when menthol is banned.

The study indicates that switching to non-menthol cigarettes does not lead to more hazardous smoking behavior, and may even support increased cessation efforts among menthol smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. Kotlyar, M., Shanley, R., Dufresne, SR., et al.[2022]

Studies comparing menthol and nonmenthol cigarettes have shown inconsistent results regarding their toxicity, leading manufacturers to claim that menthol does not increase harm.

The authors argue that focusing solely on toxicity is too limited and does not adequately address the broader public health concerns associated with menthol cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menthol should not be given a free pass based on studies of biomarkers of toxicity. Clark, PI., Gardiner, P.[2018]

A study involving 29 menthol cigarette smokers showed that switching to non-menthol cigarettes led to a significant reduction in daily cigarette consumption by an average of 2.2 cigarettes, indicating a potential decrease in smoking behavior if menthol cigarettes were banned.

Participants also experienced a notable decrease in nicotine dependence (over 18%) and increased motivation and confidence to quit smoking, particularly among Black smokers, suggesting that a menthol ban could enhance public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Bold, KW., Jatlow, P., Fucito, LM., et al.[2022]

This systematic review and meta-analysis of 16 studies found no significant difference in the likelihood of daily smoking between menthol and non-menthol cigarette users, suggesting that menthol cigarettes do not have a unique impact on smoking progression.

The study highlighted limitations such as varying definitions of outcomes and a lack of longitudinal data, which hindered the ability to draw strong conclusions about the effects of menthol cigarettes on smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Evidence on the Differential Impact of Menthol versus Non-menthol Cigarette Use on Initiation and Progression to Regular Smoking: A Systematic Review and Meta-analysis. Kim, MM., Curtin, GM.[2022]

A systematic review of 82 studies indicates that menthol cigarettes are associated with higher rates of smoking initiation among youth, suggesting that menthol may play a significant role in attracting new smokers.

Menthol smokers exhibit greater nicotine dependence and face more challenges in quitting, indicating that banning menthol could improve cessation rates and overall public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menthol cigarettes and the public health standard: a systematic review. Villanti, AC., Collins, LK., Niaura, RS., et al.[2018]

A study comparing menthol (162 smokers) and nonmenthol (189 smokers) cigarette smokers found that both groups had similar levels of most harmful constituents in tobacco smoke, indicating that menthol does not significantly alter exposure to these toxic substances.

However, menthol smokers had about 16% lower levels of a specific urine metabolite of polycyclic aromatic hydrocarbons (1-hydroxyphenanthrene) and lower concentrations of certain volatile organic compounds, suggesting some differences in exposure profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Carcinogen Biomarkers in Smokers of Menthol and Nonmenthol Cigarettes: The 2015-2016 National Health and Nutrition Examination Survey Special Sample. Lin, W., Zhu, J., Hayes, JE., et al.[2023]

Menthol cigarettes are particularly popular among younger smokers, with 56.7% of 12-17 year olds and 45.0% of 18-25 year olds using them, compared to lower rates in older age groups.

While overall smoking rates for non-menthol cigarettes decreased among adolescents and young adults from 2004 to 2010, menthol cigarette use remained constant or even increased, indicating that mentholated cigarettes may hinder efforts to reduce youth smoking rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential trends in cigarette smoking in the USA: is menthol slowing progress? Giovino, GA., Villanti, AC., Mowery, PD., et al.[2022]

The FDA's proposed ban on menthol cigarettes in April 2022 sparked significant discussion on Twitter, with many posts expressing distrust in government and concerns about racial discrimination related to the ban.

The analysis of 1041 tweets revealed that while some posts highlighted potential public health benefits of the ban, a large portion did not fit into specific themes, indicating a complex public sentiment that could inform future tobacco control communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of Twitter Posts About the U.S. Food and Drug Administration's Menthol Ban. Allem, JP., Donaldson, SI., Vogel, EA., et al.[2023]

A study analyzing 1941 tweets about the FDA's proposed menthol cigarette ban found that 27.61% of tweets expressed a positive attitude, indicating general public support for the initiative aimed at reducing youth tobacco use and related health issues.

Key positive sentiments focused on social justice and health benefits, while negative sentiments often mentioned concerns about alternative tobacco products and racial discrimination, highlighting the complexity of public opinion on tobacco regulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public Perceptions of the Food and Drug Administration's Proposed Rules Prohibiting Menthol Cigarettes on Twitter: Observational Study. Zhou, R., Tang, Q., Xie, Z., et al.[2023]

Non-Hispanic Black smokers of menthol cigarettes were significantly less likely to quit smoking compared to those who smoked nonmenthol cigarettes, indicating a potential barrier to cessation for this demographic.

Young adults (ages 18-24) were more likely to start smoking menthol cigarettes than older adults, suggesting that menthol flavoring may attract younger smokers, which could influence future tobacco use trends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Menthol Cigarette Flavor in the U.S.: Cigarette and ENDS Transitions by Sociodemographic Group. Brouwer, AF., Jeon, J., Cook, SF., et al.[2023]

After the EU menthol cigarette ban, illicit purchasing of menthol cigarettes remained low, with only 1.7% of smokers reporting such behavior a year later, indicating that the ban was effective in reducing access to menthol cigarettes.

The majority of smokers who continued to use menthol reported using non-menthol replacement brands (about 70%) or flavor accessories (42.5%), suggesting that these alternatives are significant factors in post-ban menthol use and highlighting the need for further regulations on flavor accessories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illicit purchasing and use of flavour accessories after the European Union menthol cigarette ban: findings from the 2020-21 ITC Netherlands Surveys. Kyriakos, CN., Driezen, P., Fong, GT., et al.[2023]

A ban on menthol cigarettes and flavoured cigars could lead to 12%-20% of flavoured smokers attempting to quit all tobacco use, while 32%-52% might switch to non-flavoured smoking, indicating a potential decrease in smoking rates.

Adding a ban on menthol e-cigarettes could increase the likelihood of quitting all tobacco use, but it may also lead some users to switch to non-flavoured tobacco smoking instead of quitting, suggesting that the overall impact of such a ban is uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should menthol e-cigarettes be banned? Reaction of adult smokers and users of e-cigarettes to hypothetical bans. Yang, Y., Lindblom, EN., Ward, KD., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. [2022]

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

Menthol should not be given a free pass based on studies of biomarkers of toxicity. [2018]

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

Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. [2022]

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

Assessing the Evidence on the Differential Impact of Menthol versus Non-menthol Cigarette Use on Initiation and Progression to Regular Smoking: A Systematic Review and Meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Menthol cigarettes and the public health standard: a systematic review. [2018]

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

Comparison of Carcinogen Biomarkers in Smokers of Menthol and Nonmenthol Cigarettes: The 2015-2016 National Health and Nutrition Examination Survey Special Sample. [2023]

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

Differential trends in cigarette smoking in the USA: is menthol slowing progress? [2022]

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

An Analysis of Twitter Posts About the U.S. Food and Drug Administration's Menthol Ban. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Public Perceptions of the Food and Drug Administration's Proposed Rules Prohibiting Menthol Cigarettes on Twitter: Observational Study. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Impact of Menthol Cigarette Flavor in the U.S.: Cigarette and ENDS Transitions by Sociodemographic Group. [2023]

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

Illicit purchasing and use of flavour accessories after the European Union menthol cigarette ban: findings from the 2020-21 ITC Netherlands Surveys. [2023]

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

Should menthol e-cigarettes be banned? Reaction of adult smokers and users of e-cigarettes to hypothetical bans. [2023]