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

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use
• Intervention / Treatment: Other: Tobacco product administration and assessment

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Center for the Study of Tobacco Products

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 the study protocol
• smoke cigarettes at least 3 days per week, and on those days, at least one cigarette is smoked per day
• positive urine cotinine test

Exclusion Criteria:

• Women who are breastfeeding or test positive for pregnancy (by urinalysis) at screening.
• Individuals with the following self-reported current, diagnosed medical condition(s) will be excluded automatically: uncontrolled high blood pressure (via self-report or observed at screening; BP must be less than 160/100), heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures.
• Individuals with other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor. We ask a variety of questions about participants' medical conditions that are not necessarily exclusionary to be able to consult with the medical monitor about these conditions. Participants with any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations.
• Individuals with current, diagnosed, uncontrolled psychiatric conditions will be excluded. A controlled psychiatric illness is defined as one where the individual is taking medication and/or receiving other treatment (e.g., psychotherapy). In addition, individuals who have been to the ER and/or been hospitalized for a psychiatric condition in the past year will be excluded. Individuals with past-month use of cocaine, opioids, benzodiazepines, and methamphetamine or other illegal substances (other than cannabis) will be excluded. Individuals who report using cannabis more than 15 days in the past 30 and/or alcohol more than 25 days in the past 30 days will be excluded.
• Participants who choose not to answer questions related to inclusion/exclusion criteria will be excluded.
• Participants who indicate their sex assigned at birth is female will be excluded if they are breastfeeding or test positive for pregnancy (by urinalysis) at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Participants; All participants will receive the same interventions in the same order.

Other: Tobacco product administration and assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Order effects are not assessed in this study design. Intensity, as measured by DPT, is a self-report measure used to assess the reinforcing efficacy or motivational value of a substance. It is a specific quantitative index that refers to the maximum amount of a drug a person would consume if it were available at zero or minimal cost. For this assessment, intensity is measured in puffs (e.g., 0-100 puffs if each puff were free).	There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
Price Sensitivity 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. Order effects are not assessed in this study design. Price sensitivity (α; change in amount purchased as price increases) as measured by DPT. By analyzing these metrics, researchers can quantify and compare the motivational strength and reinforcing value of different substances or different doses, providing insight into the overvaluation of drugs that contributes to addiction. (e.g., 0% to 1% range) DPT outcomes included: breakpoint (highest price participants were willing to pay), intensity (consumption at zero cost), and price sensitivity (α; change in amount purchased as price increases	There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
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. Order effects are not assessed in this study design. Breakpoint, as measured by DPT, is defined as the first price at which a participant's consumption of a hypothetical drug product is suppressed to zero. The DPT is a behavioral economics assessment tool used to measure the reinforcing value (or abuse liability) of substances. Participants are asked to report how much of a drug they would consume at a series of escalating prices, assuming no access to other similar products and that all consumption would occur within a specified time period (e.g., one day). (e.g. $0.00 to $10.00 range)	There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
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. Order effects are not assessed in this study design. CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a menthol-flavored NJOY Ace 2.4% Nicotine ECIG they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each menthol-flavored NJOY Ace 2.4% Nicotine ECIG puff cost $0.10.The outcome of the task is cross-price elasticity.	There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective measures of nicotine withdrawal	Nicotine withdrawal will be measured using the Adapted Minnesota Nicotine Withdrawal Scale (MNWS), higher numbers indicate more nicotine dependence.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Subjective measures of nicotine side effects	Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS), higher scores indicate more intense 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	Product effects will be measured using Direct Effects of Tobacco VAS Scale, higher scores indicate more intense product effects.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
General Labeled Magnitude Scale	Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms), higher scores indicate stronger perceptions of nicotine effects.	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Labeled Hedonic Scale	Labeled Hedonic Scale measures nicotine abstinence symptoms, higher scores indicate higher abstinence symptoms	Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
Change in Heart Rate	Heart rate (measured in bpm)	Recorded throughout each 1 hour and 10 minutes/2 hour and 15 minute study session using automated software every 10 seconds.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Caroline O Cobb, PhD, Virginia Commonwealth University; Principal Investigator: Andrew Barnes, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Tobacco Use; Electronic Cigarette; Nicotine Flux
• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping; Tobacco Use; Investigative Techniques; Therapeutics; Behavior Control; Immobilization; Restraint, Physical
• Other Study ID Numbers: HM20025464; 2U54DA036105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes