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Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

Not Applicable
Completed
Conditions
Electronic Cigarette Use
Interventions
Other: Tobacco product administration and assessment
Registration Number
NCT05971823
Lead Sponsor
Virginia Commonwealth University
Brief Summary

The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users.

The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • healthy (determined by self-report)
  • at least 18 years old
  • willing to provide informed consent
  • able to attend the lab and use designated products according to study protocol
  • smoke cigarettes at least 3 days per week and on those days at least 1 cigarette smoked per day
  • positive urine cotinine test
Exclusion Criteria
  • Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
  • Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavorTobacco product administration and assessment-
Own Brand CigaretteTobacco product administration and assessment-
NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavorTobacco product administration and assessment-
NJOY Ace 5.0% nicotine ECIG - Menthol flavorTobacco product administration and assessment-
NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavorTobacco product administration and assessment-
NJOY Daily 6.0% nicotine ECIG - Menthol flavorTobacco product administration and assessment-
NJOY Ace 2.4% nicotine ECIG - Menthol flavorTobacco product administration and assessment-
Primary Outcome Measures
NameTimeMethod
Pmax of Drug Purchase Task (DPT)Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.

Intensity of Drug Purchase Task (DPT)Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.

Cross-price elasticity of the Cross Product-DPTEach CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices.

Breakpoint of Drug Purchase Task (DPT)Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.

Elasticity of Drug Purchase Task (DPT)Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.

Omax of Drug Purchase Task (DPT)A DPT will be Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session once for each arm.

The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Center for the Study of Tobacco Products

🇺🇸

Richmond, Virginia, United States

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