Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
1 other identifier
interventional
124
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedJuly 11, 2023
July 1, 2023
3 months
May 18, 2020
July 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Subjective Appeal
Self-report measures of product appeal will be completed following e-cigarette self-administration.
1 hour
Sensory Appeal
Self-report measures of product appeal will be completed following e-cigarette self-administration.
1 hour
Study Arms (20)
E-cigarette e-liquid 1
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 2
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 3
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 4
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 5
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 6
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 7
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 8
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 9
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 10
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 11
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 12
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 13
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 14
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 15
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 16
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 17
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 18
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 19
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
E-cigarette e-liquid 20
EXPERIMENTALParticipants will self-administer an e-cigarette e-liquid.
Interventions
Participants will self-administer an experimenter-provided e-cigarette.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90033, United States
Related Publications (2)
Tackett AP, Dai HD, Han DH, Vogel EA, Coreas SI, Jafarzadeh N, Gonzalez Anaya MJ, Patel D, Peraza N, Mason TB, Leventhal AM. Appeal of e-cigarette flavors: Differences between never and ever use of combustible cigarettes. Drug Alcohol Depend. 2023 May 1;246:109849. doi: 10.1016/j.drugalcdep.2023.109849. Epub 2023 Mar 23.
PMID: 37028103DERIVEDLeventhal 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.
PMID: 33433597DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam M Leventhal, PhD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Preventive Medicine
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 22, 2020
Study Start
December 1, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
July 11, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share