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OpenTrials
Completed

NCT Number: NCT06617520

Attitudes and Smoking Perceptions in the Real Environment

This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)

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Key information

Conditions

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

About this study

Participants will attend 4 laboratory sessions that differ by cigarillo smoked: own brand and a then commercially available study cigarillo (Garcia y Vega game cigarillo) in tobacco flavor, concept flavor, and characterizing flavor. Consistent with our work and other's published work8-10, a baseline (BL) period will measure appeal to smoking one's usual brand cigarillo in their home environment for 7 days and then once in the laboratory (>12-hour abstinence), at the end of the 7 days. Participants will then undergo 3 experimental conditions (counterbalanced, within-subjects): (1) 7 days smoking a concept flavored study cigarillo; (2) 7 days smoking a characterizing flavored study cigarillo; and (3) 7 days smoking a tobacco flavored study cigarillo. Participants will be instructed to switch their usual brand cigarillo for the assigned study cigarillo for each 7-day period. Other tobacco use will be allowed during that time without specific instruction to model real-world behavior. On the last day of each 7-day period of "take home" use, abstinent participants (>12 hours) will smoke the assigned study cigarillo in the lab ad libitum, where subjective effects (e.g., satisfaction, craving reduction, psychological reward, throat hit), smoke exposure (CO boost), and behavior (e.g., number of puffs) will be assessed During each 7-day period of exposure, participants will complete assessments of cigarillo and other tobacco use and subjective effects to cigarillo use via once daily EMA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages18 to 34
  • Smoke little cigars/cigarillos (LCCs) "some days" or "everyday"
  • Ability to read English at an 8th grade level or higher
  • No immediate plans to quit using tobacco

Exclusion criteria

  • Current use of nicotine replacement therapy (NRT)
  • 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 each of two study 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.

Treatment and study plan

Cigarillo flavor type

Other

Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor

Primary outcomes

  1. Subjective response to smoking

    Time frame: Laboratory visits, up to 3 weeks after the baseline

    average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7

  2. Number of cigarillos smoked

    Time frame: Daily smartphone surveys, up to 3 weeks after the baseline

    The number of cigarillos smoked during each 7-day take-home period

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Presbyterian Health Foundation

Registry information

Acronym: ASPIRE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.