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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Electronic Cigarette Use

Treatments: Other: Tobacco product administration and assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05971823

HM20025464

2U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 7 patient groups

Own Brand Cigarette

Active Comparator group

Treatment:

Other: Tobacco product administration and assessment

NJOY Ace 2.4% nicotine ECIG - Menthol flavor

Experimental group

Treatment:

Other: Tobacco product administration and assessment

NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor

Experimental group

Treatment:

Other: Tobacco product administration and assessment

NJOY Ace 5.0% nicotine ECIG - Menthol flavor

Experimental group

Treatment:

Other: Tobacco product administration and assessment

NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor

Experimental group

Treatment:

Other: Tobacco product administration and assessment

NJOY Daily 6.0% nicotine ECIG - Menthol flavor

Experimental group

Treatment:

Other: Tobacco product administration and assessment

NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor

Experimental group

Treatment:

Other: Tobacco product administration and assessment