Clinical trial NCT04399031: Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
Official title: Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Cigarette Use, Electronic
Vaping
Cigarette Smoking
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 124
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, young adult vapers (N=100) and adult smokers (N=100) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation).


Eligibility criteria: Inclusion Criteria:

Vapers/E-cigarette Users

* E-cigarette/vaping device use at least three days per week for at least 2 months
* Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

* Daily cigarette smoking for at least two years
* Currently smoke at least four cigarettes per day
* Interested in trying an e-cigarette or current use of an e-cigarette

Exclusion Criteria:

Vapers/E-cigarette Users

* Pregnant or breastfeeding
* Desire to cut down on use of e-cigarette/vaping device

Cigarette Smokers

* Pregnant or breastfeeding
* Current daily use of other combustible tobacco products (such as cigars)

Primary outcomes:
measure: Subjective Appeal
timeFrame: 1 hour
measure: Sensory Appeal
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Adam M Leventhal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leventhal AM, Madden DR, Peraza N, Schiff SJ, Lebovitz L, Whitted L, Barrington-Trimis J, Mason TB, Anderson MK, Tackett AP. Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2032757. doi: 10.1001/jamanetworkopen.2020.32757.