Attitudes and Smoking Perceptions in the Real Environment (ASPIRE)

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)

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Cigarillo flavor type

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • TSET Health Promotion Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tobacco flavor cigarillo; A participant will use a tobacco flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory	Other: Cigarillo flavor type; Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor
Experimental: Concept flavor cigarillo; A participant will use a concept flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory	Other: Cigarillo flavor type; Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor
Experimental: Characterizing flavor; A participant will use a characterizing flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory	Other: Cigarillo flavor type; Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cigarillos smoked	The number of cigarillos smoked during each 7-day take-home period	Daily smartphone surveys, up to 3 weeks after the baseline
Subjective response to smoking	average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7	Laboratory visits, up to 3 weeks after the baseline

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Presbyterian Health Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Tobacco Use
• Other Study ID Numbers: ASPIRE; ST116745 (Other Grant/Funding Number: Presbyterian Health Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing may be available at the discretion and with the permission of the university and an approved data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No