Flavored Cigarillos for Tobacco Addiction

(ASPIRE-II Trial)

Overseen By Project Manager

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Nicotine replacement, Stop smoking

Disqualifiers: Pregnancy, Heart disease, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different flavors of cigarillos affect tobacco use among young adults. The researchers aim to assess how flavors influence taste, enjoyment, smoking behavior, and purchasing decisions. Participants will smoke various flavored cigarillos in a lab setting to gather data on these effects. Ideal participants are U.S. residents aged 18-34 who regularly smoke cigarillos and have tried flavored tobacco before. As an unphased study, this trial offers a unique opportunity to contribute to understanding the impact of flavors on smoking habits.

Will I have to stop taking my current medications?

The trial requires that you do not use nicotine replacement therapy or stop smoking medication. Other medications are not mentioned, so the protocol does not specify if you need to stop taking them.

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

Studies have shown that smoking flavored cigarillos can have effects similar to cigarettes. For example, research indicates they can raise heart rate and blood pressure, common effects of tobacco use. Users may also be exposed to harmful substances.

Evidence suggests that the flavors in these cigarillos make them more appealing and easier to use, especially for young people. This increased appeal can lead to more frequent use, potentially increasing exposure to harmful substances.

Tobacco-flavored cigarillos also carry risks. They can be more toxic than cigarettes and have been linked to lung and upper digestive tract cancers. Regular use of these products can lead to serious health issues like heart disease.

Overall, while flavored cigarillos may seem different from cigarettes, they carry similar risks. Participants should be aware of these potential health impacts when considering joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these flavored cigarillo treatments because they offer a new way to understand smoking behavior and addiction. Unlike current smoking cessation treatments that often rely on medications like nicotine replacement therapies or prescription drugs such as varenicline, this trial uses different flavors of cigarillos to see how taste influences smoking habits. By studying concept, characterizing, and tobacco-flavored cigarillos, researchers hope to uncover how different flavors impact cravings and satisfaction, which could lead to more effective strategies for reducing tobacco use.

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

This trial will compare different types of flavored cigarillos. Studies have shown that flavored cigarillos, with their various tastes and scents, can make smoking more appealing and enjoyable, especially for young adults. Research indicates these flavors increase the likelihood of continued smoking by enhancing taste and smell. However, flavored cigarillos can raise heart rate and blood pressure, similar to cigarettes, and expose users to harmful substances. Participants in this trial will smoke either a concept flavored cigarillo, a characterizing flavored cigarillo, or a tobacco-flavored cigarillo. Tobacco-flavored cigarillos do not seem to affect the desire to quit smoking, suggesting that removing flavors might not change the motivation to stop using tobacco. Overall, while flavored cigarillos can make smoking more enjoyable, they may also pose health risks similar to regular cigarettes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young adults who are currently using cigarillos. The study aims to understand how different flavors of cigarillos affect their appeal and usage, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Ability to read English at an 8th grade level or higher

No immediate plans to quit using tobacco

More than 1 prior experience, even 1 puff, with a flavored tobacco product

Exclusion Criteria

Pregnant, planning to become pregnant, or currently breastfeeding

Inability to abstain from nicotine/tobacco products for at least 12 hours prior to lab sessions

I am currently using nicotine replacement therapy or medication to quit smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants smoke different flavored cigarillos and their effects on tobacco product appeal are measured

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smoking outcomes

Trial Overview The study investigates the impact of various flavored cigarillo types on users' enjoyment, satisfaction, taste perception, actual smoking behavior like puff count, and purchasing decisions in a simulated tobacco marketplace setting.

How Is the Trial Designed?

Group I: Tobacco flavored cigarillo Experimental Treatment 1 Intervention

Participants will smoke a tobacco flavored cigarillo

Group II: Concept flavored cigarillo Experimental Treatment 1 Intervention

Participants will smoke a concept flavored cigarillo in the lab

Group III: Characterizing flavored cigarillo Experimental Treatment 1 Intervention

Participants will smoke a characterizing flavored cigarillo

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

Users of high-nicotine/tar-yield cigarettes have a significantly greater risk of developing nicotine dependence compared to those who use lower-nicotine/tar-yield cigarettes, even after accounting for various sociodemographic factors.

This increased risk of dependence was consistent across different definitions of nicotine dependence and was observed in both adult and adolescent smokers, highlighting the need for further research on the implications of marketing and availability of these high-yield cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of High-Nicotine/Tar-Yield (Full-Flavor) Cigarettes and Risk for Nicotine Dependence in Nationally Representative Samples of US Smokers. Redner, R., White, TJ., Bunn, JY., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5130284/

Appeal and Impact of Characterizing Flavors on Young ... Studies also suggest that young adults with a history of LCC smoking report positive affect (ie, enjoyed the taste and smell). Characterizing flavors also may ...

2. fda.gov fda.gov/media/157593/download

Scientific Assessment of the Impact of Flavors in Cigar ... Many studies report multiple outcomes by flavored tobacco product use, overall tobacco use, cigar use by subtype, age category, etc., so I ...

3. federalregister.gov federalregister.gov/documents/2022/05/04/2022-08993/tobacco-product-standard-for-characterizing-flavors-in-cigars

Tobacco Product Standard for Characterizing Flavors in ... Characterizing flavors in cigars, such as strawberry, grape, cocoa, and fruit punch, increase appeal and make the cigars easier to use, particularly among ...

4. academic.oup.com academic.oup.com/ntr/article/26/7/816/7492742

A Longitudinal Analysis of Flavored Cigar Use and Cigar ... We found that flavored cigar use was associated with a lower risk of short-term but not long-term cigar smoking cessation.

5. withpower.com withpower.com/trial/phase-cigarillo-flavor-5-2025-8ebb6

Flavored Cigarillos for Tobacco Addiction (ASPIRE-II Trial) Research on flavored cigarillos shows that they can increase heart rate and blood pressure, similar to cigarettes, and may expose users to harmful substances.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11339174/

What Is (Un)Flavored? A Scoping Review ... Research focused on tobacco product flavors allows for an assessment of the potential health impacts associated with different flavors, or if a specific flavor ...

7. tobacco.ucsf.edu tobacco.ucsf.edu/fda%E2%80%99s-proposed-rule-prohibiting-characterizing-flavors-cigars-will-reduce-their-appeal-and-will-therefore-reduce-initiation-rates-reduce-tobacco-related-deaths-and-diseases-and-reduce-health-disparities

FDA's proposed rule prohibiting characterizing flavors in ... We support the Food and Drug Administration's proposed rule prohibit characterizing flavors in cigars because it will reduce initiation rates of smoking cigars ...

8. aacr.org aacr.org/wp-content/uploads/2022/08/AACR-Comment-on-Flavored-Cigar-Standard.pdf

AACR-Comment-on-Flavored-Cigar-Standard.pdf The discrepancy in trends between cigarette and cigar smoking can be partially explained by the prevalence of flavored cigars while the TCA.