Tobacco Regulations for Smoking

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mikhail N Koffarnus

Disqualifiers: Under 21, Non-English speakers, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how proposed tobacco regulations might impact tobacco users in Appalachian Kentucky, a rural and underserved area. Researchers focus on the effects of three different regulations, including reduced nicotine levels and flavor restrictions, by observing participants' behaviors and preferences in a simulated shopping environment. Participants will track their tobacco use and complete online surveys over nine weeks. The trial seeks individuals who use nicotine or tobacco products daily and do not plan to quit soon.

As an unphased trial, participants can contribute to important research that could shape future tobacco policies.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cigarettes with very low nicotine are generally well-tolerated by users. Studies indicate that these cigarettes help people smoke less without causing many side effects. For example, people tend to smoke less intensely and report fewer negative health effects. This occurs partly because these cigarettes contain less nicotine, which can lower heart-related risks. Overall, these findings suggest that very low nicotine cigarettes could be a safer choice compared to regular cigarettes, though no tobacco product is completely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tobacco regulation strategies because they aim to tackle smoking addiction in innovative ways. Unlike traditional approaches that rely on cessation aids like nicotine patches or gum, this trial explores the impact of reducing nicotine levels in cigarettes, which could potentially lessen addiction by decreasing nicotine dependence. Additionally, by restricting flavors in both combustible and noncombustible nicotine products, the trial seeks to make these products less appealing, especially to young people. These strategies collectively offer a fresh angle on reducing smoking rates and addressing public health concerns associated with tobacco use.

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

Research has shown that cigarettes with very low nicotine can help smokers reduce cravings and withdrawal symptoms. In this trial, some participants will receive very low nicotine cigarettes, while others will receive conventional cigarettes. Specifically, individuals using very low nicotine cigarettes felt more confident about quitting and were more successful in stopping smoking compared to those who smoked regular cigarettes. One study found that information about these low nicotine cigarettes helped clear up misunderstandings about their safety. These findings suggest that very low nicotine cigarettes might be a helpful tool for people trying to cut down or quit smoking. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 21 in Appalachian Kentucky who use nicotine or tobacco daily, understand English, and don't plan to quit or seek treatment within the next 9 weeks. It aims to help a diverse rural area by studying proposed tobacco regulations.

Inclusion Criteria

I use nicotine or tobacco products every day.

I do not plan to quit smoking or using tobacco in the next 9 weeks.

I can read and understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Baseline Assessment

Participants complete a baseline assessment session to collect information on substance use patterns and addiction severity

1 week

1 visit (virtual)

Sampling Period

Participants use their assigned reduced-nicotine or conventional cigarettes for 9 weeks and complete online shopping sessions in the Experimental Tobacco Marketplace

9 weeks

Weekly online sessions

Follow-up

Participants are monitored for safety and effectiveness after the sampling period

1 week

1 visit (virtual)

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
• Very Low Nicotine Cigarette

Trial Overview Researchers are testing how three potential regulations on tobacco products might change user behavior. Participants will engage with online surveys, simulated shopping in an Experimental Tobacco Marketplace, and track their usage over a 9-week period.

How Is the Trial Designed?

Group I: Rural - Very Low Nicotine Cigarette Active Control 4 Interventions

Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.

Group II: Peri-Urban - Very Low Nicotine Cigarette Active Control 4 Interventions

Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period.

Group III: Rural - Conventional Cigarette Placebo Group 3 Interventions

Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period.

Group IV: Peri-Urban - Conventional Cigarette Placebo Group 3 Interventions

Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period.

Who Is Running the Clinical Trial?

Mikhail N Koffarnus

Lead Sponsor

Trials

3

Recruited

900+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Reducing nicotine levels in cigarettes could significantly lower tobacco-related health issues, and this approach is supported by regulatory frameworks like the U.S. Family Smoking Prevention and Tobacco Control Act.

Key research gaps were identified, such as determining the optimal nicotine dose for reducing smoking, understanding the role of other tobacco constituents, and assessing potential unintended consequences of nicotine reduction strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine reduction: strategic research plan. Hatsukami, DK., Benowitz, NL., Donny, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8785120/

A review of the evidence on cigarettes with reduced ... On average, participants who use low nicotine cigarettes over an extended period of time also reported greater average reductions in craving and withdrawal ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7329a1.htm

Adult Smoking Cessation — United States, 2022 | MMWR In 2022, approximately two thirds (67.7%) of the 28.8 million U.S. adults who smoked wanted to quit, and approximately one half (53.3%) made a ...

3. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2024/04/25/tc-2023-058556

Independent and combined effects of very low nicotine ... Conclusions VLNC messages reduced the misperception that VLNCs are less harmful than cigarettes, but adding messages about e-cigarettes did not ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624003168

Associations between compliance with very low nicotine ... Compliance with VLNCs prior to quitting increased abstinence self-efficacy and predicted better quit outcomes above and beyond baseline smoking characteristics.

5. truthinitiative.org truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats

Quitting Tobacco: Facts and Stats In 2020, 8.5% of adult current smokers successfully quit smoking in the past year, up from 7.5% in 2018.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3525710/

Very low nicotine content cigarettes and potential ... Such a standard could result in multiple beneficial outcomes including reduced cardiovascular toxicity related to nicotine, reduced smoking intensity in current ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743522001475

Effects of very low nicotine content cigarettes on smoking ... Studies show that nicotine reduction reduces smoking with few or no adverse effects. Abstract. There has been long-standing interest in a reduced-nicotine ...

8. cdc.gov cdc.gov/tobacco/e-cigarettes/health-effects.html

Health Effects of Vaping | Smoking and Tobacco Use Nicotine addiction and mental health · Lower levels of anxiety, depression, and stress · Improved positive mood and quality of life.

9. fda.gov fda.gov/tobacco-products/health-effects-tobacco-use/relative-risks-tobacco-products

The Relative Risks of Tobacco Products No tobacco product is safe. However, the health risks for different tobacco products exist on a spectrum, which is sometimes referred to as a “continuum of ...