Cigarillo Flavors for Tobacco Use

(Clarity Trial)

Overseen By Project Manager

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Smoking cessation, Nicotine replacement

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: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different flavored cigarillos affect smoking habits and perceptions among young adults. Researchers will explore how flavors, ingredients, and market policies might influence decisions to quit or switch tobacco products. Participants will be divided into groups to try various types of flavored cigarillos, including concept, characterizing, and tobacco flavors. Young adults aged 18-24 who currently smoke cigarillos and have previously tried flavored tobacco might be suitable candidates for this study. As an unphased trial, this study offers participants the opportunity to contribute to important research that could shape future tobacco policies and product regulations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using smoking cessation medications or nicotine replacement therapy.

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

Research shows that smoking flavored cigarillos affects the body similarly to smoking cigarettes. Studies indicate they may raise heart rate and blood pressure and expose users to harmful substances. Some young adults believe smoking flavored little cigars and cigarillos is as harmful as smoking cigarettes.

Flavors like strawberry or grape make cigarillos more appealing and easier to use, especially for young adults. Despite their appeal, many people do not fully understand the health risks. Some believe these flavored options are less harmful than cigarettes, but this is not necessarily true.

For tobacco-flavored cigarillos, the risks mirror those of other flavored cigarillos. Smoking these products can also increase heart rate and blood pressure and expose users to harmful substances. Overall, no tobacco product is safe, and all carry health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore how different cigarillo flavors influence tobacco use among young people. Unlike traditional studies that often focus on cigarette consumption, this trial zeroes in on cigarillos, which are becoming increasingly popular. By investigating concept, characterizing, and tobacco flavors, the study could reveal how flavor impacts smoking habits. This could inform new legislation and regulations, potentially leading to more effective strategies to curb tobacco use among youth.

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

This trial will compare the effects of different cigarillo flavors on smoking behavior. Research has shown that flavored cigarillos, with tastes like strawberry and grape, often make cigars more appealing and easier for young adults to try. Studies have found that using flavored cigars links to a lower chance of quitting in the short term and does not aid in quitting permanently. These flavors increase the likelihood of starting and continuing to smoke, leading to more harm from tobacco. Tobacco-flavored cigarillos show a similar pattern of short-term quitting, but graphic warnings on these products can encourage more quit attempts. Overall, flavored cigarillos may not effectively help people quit smoking permanently. Participants in this trial will be randomized to smoke one of three assigned flavors: concept flavor, characterizing flavor, or tobacco flavor. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy Cohn, OhD

Principal Investigator

University of Oklahoma Health Sciences

Are You a Good Fit for This Trial?

This trial is for young adults who currently smoke cigarillos. It aims to understand how different flavors and ingredients in these products affect their smoking behavior, perceptions, and potential changes like quitting or switching brands under various tobacco control policies.

Inclusion Criteria

Report past 30-day use of a cigarillo

Ability to read English at least an 8th grade level

No immediate plans to quit using tobacco

Exclusion Criteria

Pregnant, planning to become pregnant, or currently breastfeeding

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

Unwillingness to use the research cigarillos in the lab

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to smoke assigned flavored cigarillos and their smoking behavior and perceptions are examined

2 weeks

Multiple visits for smoking sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)

Trial Overview The study is testing the impact of three different brands of flavored cigarillos on participants' smoking habits. It will also assess how users perceive these products and their intentions regarding tobacco use if certain flavors were regulated or restricted.

How Is the Trial Designed?

Group I: Tobacco flavor Experimental Treatment 3 Interventions

Participants will be randomized to smoke a tobacco flavored cigarillo

Group II: Concept flavor Experimental Treatment 3 Interventions

Participants will be randomized to smoke one of the three assigned concept flavored cigarillos

Group III: Characterizing flavor Experimental Treatment 3 Interventions

Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11190056/

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

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. srnt.org srnt.org/wp-content/uploads/2024/11/srnt_comment_standard_for_ch.pdf

SRNT Comment Standard for Characterizing Flavors in ... A. Characterizing flavors in cigars increase initiation and use, discourage users to quit, and increase harm from tobacco. Evidence from local and state ...

5. academic.oup.com academic.oup.com/ntr/article/27/2/333/7713115

Public Health Impact of a Ban on Flavored Cigars Cigar users exhibited less stable use than cigarette users, with a large portion of cigar users switching to cigarette use each year. Past ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5896812/

A Qualitative Investigation of Young Adult Smokers' Risk ... Flavored little cigar and cigarillo (LCC) smoking prevalence rate is increasing among young adults; little is known about their comprehension of its risks.

7. ada.org ada.org/-/media/project/ada-organization/ada/ada-org/files/advocacy/220802_fda_tobacco_flavoredcigars_coalition.pdf

Coalition letter urging FDA to prohibit characterizing flavors ... Disproportionately higher exposure to secondhand smoke adds to these higher health risks. Data from the 2018-2019 PATH study found the highest ...

8. fda.gov fda.gov/media/157643/download

Review of Studies Assessing the Potential Impact of ... This document provides a reproducible, transparent, and documented (RTD) review of evaluation studies that examine the impact of flavored tobacco sales ...

9. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-17216-z

Patterns of use, perceptions, and cardiopulmonary health risks ... Participants believed flavored LCCs to be less harmful [83], less likely to cause cancer [83], and less dangerous than cigarettes in regards to ...