Clinical trial NCT06617520: Attitudes and Smoking Perceptions in the Real Environment
Official title: Attitudes and Smoking Perceptions in the Real Environment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Presbyterian Health Foundation
First posted: 2024-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective response to smoking
timeFrame: Laboratory visits, up to 3 weeks after the baseline
measure: Number of cigarillos smoked
timeFrame: Daily smartphone surveys, up to 3 weeks after the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: TSET Health Promotion Research Center
state: Oklahoma
Study officials:
References: