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

NCT07162935 | Recruiting

• 2 other identifiers: ClarityR01DA062632-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cigar Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (2)

• Puff number

  Number of cigarillo puffs

  From enrollment to the end of the final smoking visit, approximately 2 weeks

• Subjective reward from smoking

  Self-reported reward from cigarillo smoking from a questionnaire. This scale has 5 questions with response options ranging from 1 - not at all to 7 - extremely. The score is averaged across the number of items. Higher ratings indicate greater psychological reward

  From enrollment to the end of the final smoking visit, approximately 2 weeks

Study Arms (3)

Concept flavor

EXPERIMENTAL

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

Other: Cigarillo brand 1; Other: Cigarillo brand 2; Other: Cigarillo brand 3

Characterizing flavor

EXPERIMENTAL

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

Other: Cigarillo brand 1; Other: Cigarillo brand 2; Other: Cigarillo brand 3

Tobacco flavor

EXPERIMENTAL

Participants will be randomized to smoke a tobacco flavored cigarillo

Other: Cigarillo brand 1; Other: Cigarillo brand 2; Other: Cigarillo brand 3

Interventions

Cigarillo brand 1 OTHER

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

Characterizing flavor; Concept flavor; Tobacco flavor

Cigarillo brand 2 OTHER

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

Characterizing flavor; Concept flavor; Tobacco flavor

Cigarillo brand 3 OTHER

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

Characterizing flavor; Concept flavor; Tobacco flavor

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute on Drug Abuse (NIDA): collaborator
• West Virginia University: collaborator

Study Sites (2)

University of Oklahoma Health Campus

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Cigar Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior

Study Officials

• Amy Cohn, OhD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

405-271-7759; heal-lab@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Other

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): March 2, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The investigative team will meet the data submission and release timeframes specified by the funding agency and policies, as described on NIH's data sharing webpage.

Locations

US (2)