CClinicalTrials.gg
RecruitingNCT06668350ASPIRE-IIUpdated Aug 17, 2025

Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II

An interventional study of Smoking outcomes in Cigarillo Flavor, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 34 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cigarillo Flavor
03

In context

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 34 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    Concept flavored cigarillo

    Participants will smoke a concept flavored cigarillo in the lab

    Other: Smoking outcomes

  • Experimental
    Characterizing flavored cigarillo

    Participants will smoke a characterizing flavored cigarillo

    Other: Smoking outcomes

  • Experimental
    Tobacco flavored cigarillo

    Participants will smoke a tobacco flavored cigarillo

    Other: Smoking outcomes

Interventions

  • OtherSmoking outcomes

    Participants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide

06

What researchers measure

Primary outcomes

  1. Puff volume

    Volume of inhaled cigarillo puffs

    Time frame: From enrollment to the end of the study at 6 weeks

  2. Subjective effects 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.

    Time frame: From enrollment to the end of the study at 6 weeks

  3. Exhaled carbon monoxide

    Changes in exhaled carbon monoxide (CO boot) following cigarillo smoking

    Time frame: From enrollment to the end of the study at 6 weeks

07

Study locations

1 of 1 sites recruiting
  • TSET Health Promotion Research Center
    Oklahoma City, Oklahoma 73012, United States
    • Project Manager · Contact · heal-lab@ouhsc.edu · 405-271-1903
    • Amy Cohn, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06668350
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
Oct 31, 2024
Start date
Jun 27, 2025
Primary completion
Feb 1, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Aug 17, 2025

Study contacts

Project Manager
Contact
heal-lab@ouhsc.edu
1-405-271-7759

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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