NCT04399031

Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1

Completed NA Last updated 11 July 2023

What this trial tests

NA trial testing E-cigarette e-liquid in Electronic Cigarette Use in 124 participants. Completed in 1 March 2020.

Timeline

1 December 2019

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	124
Start date	1 December 2019
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across United States

Drugs / interventions tested

• E-cigarette e-liquid — full drug profile →

Conditions studied

• Electronic Cigarette Use — all drugs for Electronic Cigarette Use →
• Cigarette Use, Electronic — all drugs for Cigarette Use, Electronic →
• Vaping — all drugs for Vaping →
• Cigarette Smoking — all drugs for Cigarette Smoking →

Sponsor

University of Southern California

Who can join

21 and older, any sex, with Electronic Cigarette Use or Cigarette Use, Electronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial.
   Leventhal AM, Madden DR, Peraza N, Schiff SJ, et al · · 2021 · cited 144× · PMID 33433597 · DOI 10.1001/jamanetworkopen.2020.32757
2. Characterizing different-flavored e-cigarette solutions from user-reported sensory attributes and appeal.
   Anderson MK, Whitted L, Mason TB, Pang RD, et al · · 2023 · cited 7× · PMID 35467923 · DOI 10.1037/pha0000563
3. Appeal of e-cigarette flavors: Differences between never and ever use of combustible cigarettes.
   Tackett AP, Dai HD, Han DH, Vogel EA, et al · · 2023 · cited 3× · PMID 37028103 · DOI 10.1016/j.drugalcdep.2023.109849