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

University of Southern California logo

University of Southern California

Status

Completed

Conditions

Cigarette Smoking
Electronic Cigarette Use
Vaping
Cigarette Use, Electronic

Treatments

Drug: E-cigarette e-liquid

Study type

Interventional

Funder types

Other

Identifiers

NCT04399031
HS-18-00839 Substudy 1

Details and patient eligibility

About

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).

Enrollment

124 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

124 participants in 20 patient groups

E-cigarette e-liquid 1
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 2
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 3
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 4
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 5
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 6
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 7
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 8
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 9
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 10
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 11
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 12
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 13
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 14
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 15
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 16
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 17
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 18
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 19
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid
E-cigarette e-liquid 20
Experimental group
Description:
Participants will self-administer an e-cigarette e-liquid.
Treatment:
Drug: E-cigarette e-liquid

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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