Clinical trial NCT05971823: Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
Official title: Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Keywords: Electronic Cigarette
Nicotine Flux
Tobacco Use
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete 4, within-subject, laboratory sessions that differ by the product used: 1) own brand cigarette, 2) NJOY Ace 2.4% nicotine ECIG (Menthol and Classic Tobacco flavor), 3) NJOY Ace 5.0% nicotine ECIG (Menthol and Classic Tobacco flavor), and 4) NJOY Daily ECIG 6% nicotine (Menthol and Extra Rich Tobacco). The first condition for all participants will be their own brand cigarette. The subsequent three sessions will be assigned using a Latin-square following enrollment, and within each session participants will sample and evaluate two flavors of each session's product (session flavor order is incorporated into the Latin-square condition order assignment).
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Breakpoint of Drug Purchase Task (DPT)
timeFrame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
measure: Elasticity of Drug Purchase Task (DPT)
timeFrame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
measure: Omax of Drug Purchase Task (DPT)
timeFrame: 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.
measure: Pmax of Drug Purchase Task (DPT)
timeFrame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
measure: Intensity of Drug Purchase Task (DPT)
timeFrame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
measure: Cross-price elasticity of the Cross Product-DPT
timeFrame: Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
Secondary outcomes:
Other outcomes:
measure: Subjective measures of nicotine withdrawal
timeFrame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
measure: Subjective measures of nicotine side effects
timeFrame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
measure: Subjective measures of product effects
timeFrame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
measure: General Labeled Magnitude Scale
timeFrame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
measure: Labeled Hedonic Scale
timeFrame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
measure: Change in Heart Rate
timeFrame: Recorded throughout each 1 hour and 10 minutes/2 hour and 15 minute study session using automated software every 10 seconds.
Locations:
city: Richmond
country: United States
facility: Center for the Study of Tobacco Products
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Caroline O Cobb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Andrew Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References: