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

NCT05971823 | Completed

• 2 other identifiers: HM200254642U54DA036105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarette Use

Keywords

Electronic Cigarette; Nicotine Flux; Tobacco Use

Outcome Measures

Primary Outcomes (6)

• Breakpoint of Drug Purchase Task (DPT)

  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.

  Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

• Elasticity of Drug Purchase Task (DPT)

  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.

  Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

• Omax of Drug Purchase Task (DPT)

  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.

  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.

• Pmax of Drug Purchase Task (DPT)

  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.

  Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

• Intensity of Drug Purchase Task (DPT)

  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.

  Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

• Cross-price elasticity of the Cross Product-DPT

  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.

  Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session

Other Outcomes (6)

• Subjective measures of nicotine withdrawal

  Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session

• Subjective measures of nicotine side effects

  Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session

• Subjective measures of product effects

  Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session

Study Arms (7)

Own Brand Cigarette

ACTIVE COMPARATOR

Other: Tobacco product administration and assessment

NJOY Ace 2.4% nicotine ECIG - Menthol flavor

EXPERIMENTAL

Other: Tobacco product administration and assessment

NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor

EXPERIMENTAL

Other: Tobacco product administration and assessment

NJOY Ace 5.0% nicotine ECIG - Menthol flavor

EXPERIMENTAL

Other: Tobacco product administration and assessment

NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor

EXPERIMENTAL

Other: Tobacco product administration and assessment

NJOY Daily 6.0% nicotine ECIG - Menthol flavor

EXPERIMENTAL

Other: Tobacco product administration and assessment

NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor

EXPERIMENTAL

Other: Tobacco product administration and assessment

Interventions

Tobacco product administration and assessment OTHER

Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.

NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor; NJOY Ace 2.4% nicotine ECIG - Menthol flavor; NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor; NJOY Ace 5.0% nicotine ECIG - Menthol flavor; NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor; NJOY Daily 6.0% nicotine ECIG - Menthol flavor; Own Brand Cigarette

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for the Study of Tobacco Products

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Vaping; Tobacco Use

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Caroline O Cobb, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Andrew Barnes, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to device nicotine concentration and flavor used during ECIG sessions. No blinding will occur for the own brand condition.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 2, 2023
• Study Start: July 31, 2023
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)