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Clinical Trials/NCT04399031
NCT04399031CompletedNot Applicable

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

University of Southern California1 site in 1 country124 target enrollmentStarted: December 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
124
Locations
1
Primary Endpoint
Subjective Appeal

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

E-cigarette e-liquid 7

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 3

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 5

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 12

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 15

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 19

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 2

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 4

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 6

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 8

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 10

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 11

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 13

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 17

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 1

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 9

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 14

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 18

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 16

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 20

Experimental

Participants will self-administer an e-cigarette e-liquid.

Intervention: E-cigarette e-liquid (Drug)

Outcomes

Primary Outcomes

Subjective Appeal

Time Frame: 1 hour

Self-report measures of product appeal will be completed following e-cigarette self-administration.

Sensory Appeal

Time Frame: 1 hour

Self-report measures of product appeal will be completed following e-cigarette self-administration.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adam Leventhal

Professor of Preventive Medicine

University of Southern California

Study Sites (1)

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