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

473 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 9-week experiment.

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 involving reduced nicotine regulatory environment and flavor restrictions in tobacco products?

Research suggests that reducing nicotine levels in cigarettes to non-addictive levels could significantly decrease tobacco-related health issues. Additionally, restricting flavored tobacco products has been shown to reduce their availability, which may help lower usage rates. ^{1 2 3 4 5}

Is reducing nicotine in cigarettes safe for humans?

Research suggests that reducing nicotine in cigarettes could lower smoking rates and exposure to harmful chemicals, which may improve safety for smokers. However, there are concerns that smokers might smoke more intensely to compensate, potentially increasing exposure to toxic chemicals. ^{1 6 7 8 9}

How does the treatment in the Tobacco Regulations for Smoking trial differ from other treatments for smoking?

This treatment is unique because it involves reducing the nicotine content in cigarettes to levels that are not addictive, which is different from other treatments that may focus on quitting smoking through medications or behavioral therapies. This approach aims to make smoking less appealing and reduce tobacco-related health issues by targeting the addictive component directly. ^{1 2 3 10 11}

Eligibility Criteria

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 am at least 21 years old.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Nicotine reduction revisited: science and future directions. [2023]

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

Nicotine reduction: strategic research plan. [2021]

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

A Focus Group Study of Reactions to Messages about a Nicotine Reduction Policy Among People Who Use Little Cigars and Cigarillos. [2023]

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

Impact of flavoured tobacco restriction policies on flavoured product availability in Massachusetts. [2021]

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

Effects of Framing Nicotine Reduction in Cigarettes on Anticipated Tobacco Product Use Intentions and Risk Perceptions Among US Adult Smokers. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Reducing the relative value of cigarettes: Considerations for nicotine and non-nicotine factors. [2021]

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

Reduced nicotine cigarettes: smoking behavior and biomarkers of exposure among smokers not intending to quit. [2023]

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

Teens Less Susceptible to Vaping When Restricted to Tobacco-Flavored E-cigarettes: Implications for Flavored Tobacco Policies. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Flavored tobacco product use among U.S. young adults. [2022]

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

E-cigarette Price Impacts legal and Black-Market Cigarette Purchasing Under a Hypothetical Reduced-Nicotine Cigarette Standard. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Strong preference for mint snus flavor among research participants. [2022]