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Recruiting NCT07162935

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

No phase Interventional Cigar Smoking Tobacco Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cigarillo brand 1, Cigarillo brand 2, Cigarillo brand 3.
Who it may be relevant to
Registry conditions: Cigar Smoking, Tobacco Use. Basic parameters: 18 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos

Overview

This clinical trial will recruit young adults who currently use cigarillos and examine the smoking behavior and perceptions of different flavored cigarillos, product ingredients/additives impacting these perceptions, and simulated tobacco use outcomes (quitting, switching) in various policy scenarios where different types of flavors are available on the market.

Detailed description

This clinical trial will isolate the unique effects of concept descriptors on increased cigarillo use and appeal among experienced young adult cigarillo users. The study will seek to determine the addiction potential of concept flavored cigarillos by examining associations of cigarillo flavor type (concept, characterizing, tobacco) and cigarillo flavoring additives/ingredients to complementary measures of product appeal: subjective effects (e.g., satisfaction, reward, taste), actual smoking behavior (e.g., number of puffs), and simulated cigarillo purchasing, other tobacco product substitution, or quitting under different flavor ban scenarios via an Experimental Tobacco Marketplace (ETM).

Interventions

  • Other Cigarillo brand 1
    Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed
  • Other Cigarillo brand 2
    Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed
  • Other Cigarillo brand 3
    Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed

Primary outcome measures

  • Puff number [Time frame: From enrollment to the end of the final smoking visit, approximately 2 weeks]
  • Subjective reward from smoking [Time frame: From enrollment to the end of the final smoking visit, approximately 2 weeks]

Eligibility criteria

Inclusion criteria

  • Ages 18 to 24
  • 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
  • At least 1 prior experience with a flavored tobacco product
  • U.S. Citizen or permanent resident of the United States.

Exclusion criteria

  • Current use of smoking cessation pharmacotherapy or nicotine replacement therapy;
  • Pregnant, planning to become pregnant, or currently breastfeeding;
  • Past or current clinically significant heart disease or hypertension, or other smoking-related disease that could preclude successful study completion;
  • Inability to abstain from nicotine/tobacco products for at least 12 hours
  • Unwillingness to use the research cigarillos in the lab

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 2 centers
  • University of Oklahoma Health Campus — Oklahoma City
  • West Virginia University — Morgantown

Identifiers

NCT: NCT07162935 · Clarity · R01DA062632-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗