Tobacco Regulations for Smoking

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bethany Shorey Fennell

Disqualifiers: Under 18, Plans to quit, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different tobacco regulations might affect people who smoke either daily or occasionally. Participants will engage with a simulated online marketplace to observe how their choices change under various regulations, such as a reduced nicotine environment or flavor restrictions in tobacco products. This study suits adults who smoke cigarettes 4 to 30 days a month and do not plan to quit. The researchers aim to understand the impact of FDA regulations on smoking habits. Participants will complete online surveys and tests to gather this information. As an unphased trial, this study offers a unique opportunity to contribute to important research that could shape future tobacco regulations.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on tobacco use, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that these tobacco regulations are safe for participants?

Research has shown that cigarettes with very low nicotine levels can lead to positive outcomes, such as reduced nicotine exposure and decreased smoking. This suggests that lowering nicotine in cigarettes might be well-accepted by consumers.

Regarding the removal of flavors from tobacco products, studies indicate that eliminating flavors in cigars and similar products can decrease overall tobacco use. This suggests that flavor restrictions might not pose significant safety issues.

Overall, evidence suggests these approaches are generally safe, with no major side effects reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new regulatory strategies for reducing smoking. Unlike traditional methods that focus on cessation aids like nicotine replacement therapies or medications, these strategies aim to change the smoking environment itself. By reducing nicotine levels and restricting flavors in tobacco products, the trial could potentially lower smoking rates by making cigarettes less addictive and appealing. This approach represents a shift from treating addiction at the individual level to implementing broader public health measures that could have a significant impact on smoking behaviors.

What evidence suggests that this trial's treatments could be effective for tobacco regulation?

This trial will evaluate different regulatory strategies for reducing tobacco use. Research has shown that lowering nicotine in cigarettes can have positive effects. Studies found that people who smoked cigarettes with very low nicotine levels consumed less nicotine and smoked fewer cigarettes overall. Notably, those who smoked these low-nicotine cigarettes attempted to quit at twice the rate of those who smoked regular cigarettes.

In this trial, one arm will focus on the effects of a reduced nicotine regulatory environment. Another arm will assess the impact of banning flavors in cigarettes and other nicotine products. Evidence suggests that these bans can lead to less use of flavored tobacco. For example, when flavors like menthol are banned, smoking rates noticeably drop. Similarly, for non-smoking nicotine products, studies indicate that flavor bans can reduce the use of flavored tobacco among young people. Overall, these strategies aim to make smoking less attractive and help cut down on tobacco use. ^{2 6 7 8 9}

Who Is on the Research Team?

Bethany Shorey Fennell, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adult smokers, both those who smoke every day and those who don't. Participants must be willing to complete online surveys and shopping sessions in a simulated marketplace. Specific eligibility criteria are not provided.

Inclusion Criteria

Have no plans to quit nicotine/tobacco products

Consume cigarettes 4-30 days per month

Read and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants complete a single assessment including surveys and tests on personal characteristics, substance use patterns, and behavioral tasks.

1 week

1 visit (online)

Experimental Tobacco Marketplace

Participants engage in purchasing scenarios in a simulated online tobacco marketplace to model the impact of proposed tobacco product regulations.

2-4 weeks

Multiple sessions (online)

Follow-up

Participants are monitored for any changes in behavior or product valuation after the experimental sessions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reduced nicotine regulatory environment
• Restriction on characterizing flavors in combustible nicotine products
• Restriction on characterizing flavors in noncombustible nicotine products

Trial Overview The study examines how potential tobacco regulations might influence the availability of products for daily and nondaily smokers. It involves reduced nicotine levels, flavor restrictions in combustible products, and flavor bans in noncombustible nicotine items.

How Is the Trial Designed?

Group I: Nondaily smoking Experimental Treatment 3 Interventions

Participants who smoke cigarettes some days but not every day in a month

Group II: Daily smoking Experimental Treatment 3 Interventions

Participants who smoke cigarettes every day

Who Is Running the Clinical Trial?

Bethany Shorey Fennell

Lead Sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8986886/

A Systematic Review of Responses to Reduced Nicotine ... There were mixed results for intentions to use RNCs after exposure to commercial features. RNC product standard descriptors indicate individuals ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743514002217

Reduced nicotine product standards for combustible tobacco Research suggests that very low nicotine content cigarettes produce a desirable set of outcomes, including reduced exposure to nicotine, reduced smoking, and ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMp1509510

Reduced-Nicotine Cigarettes — A Promising Regulatory ... Moreover, they attempted to quit smoking at a rate double that of participants smoking standard-strength cigarettes (34.7% vs. 17% at 30-day ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807052

Evaluation of Population-Level Tobacco Control ... Our results also support the use of smoking bans to improve birth outcomes. We found that smoke-free legislation was associated with a 4% to 9% ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8186426/

Effects of Reduced-Nicotine Cigarettes Across Regulatory ... Recent efforts have explored the potential health and policy benefits of reducing nicotine, an addictive component, in combustible cigarettes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4642683/

Randomized Trial of Reduced-Nicotine Standards for ... The results of several relatively small studies suggest that cigarettes with very low nicotine content are associated with a desirable set of outcomes, ...

7. cdc.gov cdc.gov/tobacco/php/data-statistics/youth-data-tobacco/index.html

Youth and Tobacco Use Use of tobacco products, in any form, is unsafe. · Preventing tobacco product use among youth is critical to reducing tobacco use into adulthood.

8. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(24)00123-6/fulltext

Reduced nicotine in cigarettes in a marketplace with ... The results of this study demonstrated that substantially reducing the nicotine content in cigarettes (in this case about a 98% reduction compared to cigarettes ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMsr1714617

Potential Public Health Effects of Reducing Nicotine Levels ... The purpose of this analysis is to quantify the potential public health effects of enacting a regulation in the United States that makes cigarettes minimally ...