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

Trial Summary

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.

What data supports the effectiveness of flavored cigarillos as a treatment for smoking outcomes?

The research suggests that flavored cigarillos, like wine and apple flavors, have lower abuse potential compared to regular cigarettes, which might make them a less addictive alternative for smokers. However, the effectiveness of using flavored cigarillos specifically as a treatment for smoking addiction is not directly supported by the data. ^{1 2 3 4 5}

Is it safe to use flavored cigarillos for tobacco addiction treatment?

Research on flavored cigarillos shows that they can increase heart rate and blood pressure, similar to cigarettes, and may expose users to harmful substances. However, the safety of using flavored cigarillos specifically for treating tobacco addiction has not been directly studied. ^{1 3 4 6 7}

How do flavored cigarillos differ from other treatments for tobacco addiction?

Flavored cigarillos are unique because they are not a traditional treatment for tobacco addiction; instead, they are often used recreationally and can impact smoking behavior due to their appealing flavors. Unlike standard cessation methods, such as nicotine replacement therapy or medications, flavored cigarillos may actually increase the likelihood of continued tobacco use rather than help in quitting. ^{1 7 8 9 10}

What is the purpose of this trial?

This multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior (e.g., number of puffs), and tobacco product purchases via a simulated experimental tobacco marketplace.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Behavioral economic assessment of abuse liability for Black & Mild cigar flavors among young adults. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Use of multiple tobacco products in a national sample of persons enrolled in addiction treatment. [2022]

3. England 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. [2022]

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

Acute effects of flavored Black and mild cigars among young adult cigarette smokers. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Validation of the French translation and factorial structure of the Tiffany and Drobes Smoking Urge Questionnaire]. [2015]

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

Mouth Level Intake of Nicotine from Three Brands of Little Filtered Cigars with Widely Differing Product Characteristics Among Adult Consumers. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cigarillo Flavor and Motivation to Quit among Co-Users of Cigarillos and Cannabis: A Structural Equation Modeling Approach. [2022]

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

The Role of Cigarillo Flavor in the Co-Use of Cigarillos and Cannabis among Young Adults. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effect of sweet flavouring on the rewarding and reinforcing value of cigarillo use among young adults. [2023]

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

Correlates of behavior change intents in response to a hypothetical flavored cigar sales restriction among U.S. adult flavored cigar smokers. [2023]