Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II (ASPIRE-II)

August 12, 2025 updated by: University of Oklahoma

Racial/Ethnic Differences in Appeal and Preference for Flavored Little Cigars/Cigarillos: A Multi-Method Approach to Inform Tobacco Policy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73012
        • Recruiting
        • TSET Health Promotion Research Center
        • Principal Investigator:
          • Amy Cohn, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages18 to 34
  • Smoke a little cigar or cigarillo (LCCs) "some days" or "everyday" (verified by brand name of the product);
  • Ability to read English at an 8th grade level or higher; and
  • No immediate plans to quit using tobacco
  • > 1 prior experience, even 1 puff, with a flavored tobacco product
  • U.S. Citizen or permanent resident of the United States.

Exclusion Criteria:

  • Current use of nicotine replacement therapy (NRT) or stop smoking medication;
  • Pregnant, planning to become pregnant, or currently breastfeeding;
  • Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
  • Inability to abstain from nicotine/tobacco products for at least 12 hours prior to lab sessions
  • Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
  • Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concept flavored cigarillo
Participants will smoke a concept flavored cigarillo in the lab
Other: Smoking outcomes
Participants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide
Experimental: Characterizing flavored cigarillo
Participants will smoke a characterizing flavored cigarillo
Other: Smoking outcomes
Participants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide
Experimental: Tobacco flavored cigarillo
Participants will smoke a tobacco flavored cigarillo
Other: Smoking outcomes
Participants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Puff volume
Time Frame: From enrollment to the end of the study at 6 weeks
Volume of inhaled cigarillo puffs
From enrollment to the end of the study at 6 weeks
Exhaled carbon monoxide
Time Frame: From enrollment to the end of the study at 6 weeks
Changes in exhaled carbon monoxide (CO boot) following cigarillo smoking
From enrollment to the end of the study at 6 weeks
Subjective effects from smoking
Time Frame: From enrollment to the end of the study at 6 weeks
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 study at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ACS CHERC
  • CHERC-24-1160021-01-CHERC (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe