Trial Outcomes & Findings for Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste) (NCT NCT05971823)

NCT ID: NCT05971823

Last Updated: 2026-04-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

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.

Results posted on

2026-04-06

Participant Flow

Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions)

Participant milestones

Participant milestones
Measure
All Participants
Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design.
Overall Study
STARTED
30
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=30 Participants
Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) .
Age, Continuous
48.50 years
STANDARD_DEVIATION 11.62 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
15 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
Region of Enrollment
United States
30 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) .

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).

Outcome measures

Outcome measures
Measure
All Participants
n=30 Participants
Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. .
Intensity of Drug Purchase Task (DPT)
Own Brand Cigarette
172.20 number of puffs
Standard Deviation 94.90
Intensity of Drug Purchase Task (DPT)
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor
89.90 number of puffs
Standard Deviation 97.06
Intensity of Drug Purchase Task (DPT)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor
60.83 number of puffs
Standard Deviation 78.62
Intensity of Drug Purchase Task (DPT)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor
94.50 number of puffs
Standard Deviation 97.95
Intensity of Drug Purchase Task (DPT)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor
70.23 number of puffs
Standard Deviation 74.91
Intensity of Drug Purchase Task (DPT)
NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor
100.40 number of puffs
Standard Deviation 109.33
Intensity of Drug Purchase Task (DPT)
NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor
86.50 number of puffs
Standard Deviation 95.65

PRIMARY outcome

Timeframe: 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.

Population: Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who participated in the interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions). 13 subjects completed this intervention.

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

Outcome measures

Outcome measures
Measure
All Participants
n=13 Participants
Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. .
Price Sensitivity of Drug Purchase Task (DPT)
Own Brand Cigarette
.008 dollars per e-cig puff
Standard Deviation .004
Price Sensitivity of Drug Purchase Task (DPT)
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor
.030 dollars per e-cig puff
Standard Deviation .056
Price Sensitivity of Drug Purchase Task (DPT)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor
.019 dollars per e-cig puff
Standard Deviation .021
Price Sensitivity of Drug Purchase Task (DPT)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor
.022 dollars per e-cig puff
Standard Deviation .050
Price Sensitivity of Drug Purchase Task (DPT)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor
.013 dollars per e-cig puff
Standard Deviation .017
Price Sensitivity of Drug Purchase Task (DPT)
NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor
.027 dollars per e-cig puff
Standard Deviation .066
Price Sensitivity of Drug Purchase Task (DPT)
NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor
.014 dollars per e-cig puff
Standard Deviation .012

PRIMARY outcome

Timeframe: 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.

Population: Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions)

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)

Outcome measures

Outcome measures
Measure
All Participants
n=30 Participants
Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. .
Breakpoint of Drug Purchase Task (DPT)
Own Brand Cigarette
1.94 US dollars ($)
Standard Deviation 4.13
Breakpoint of Drug Purchase Task (DPT)
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor
2.00 US dollars ($)
Standard Deviation 5.19
Breakpoint of Drug Purchase Task (DPT)
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor
2.05 US dollars ($)
Standard Deviation 5.20
Breakpoint of Drug Purchase Task (DPT)
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor
1.60 US dollars ($)
Standard Deviation 3.79
Breakpoint of Drug Purchase Task (DPT)
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor
1.89 US dollars ($)
Standard Deviation 5.16
Breakpoint of Drug Purchase Task (DPT)
NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor
1.48 US dollars ($)
Standard Deviation 3.83
Breakpoint of Drug Purchase Task (DPT)
NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor
1.99 US dollars ($)
Standard Deviation 5.18

PRIMARY outcome

Timeframe: 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.

Population: 32 subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed. 4 Sessions/ 7 Conditions: Session 1.) own brand (1 cond), Session 2.) 2.4% (2 condit, Session 3.) 5% (2 condit), and Session 4.) 6% (2 condit). The session timing was not standardized, this is a difficult population to schedule.

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.

Outcome measures

Outcome measures
Measure
All Participants
n=30 Participants
Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. .
Cross-price Elasticity of the Cross Product-DPT
NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor
.245 dollars per e-cigarette puffs
Standard Deviation .110
Cross-price Elasticity of the Cross Product-DPT
NJOY Ace 2.4% Nicotine ECIG - Menthol Flavor
.149 dollars per e-cigarette puffs
Standard Deviation .123
Cross-price Elasticity of the Cross Product-DPT
NJOY Ace 2.4% Nicotine ECIG - Classic Tobacco Flavor
.193 dollars per e-cigarette puffs
Standard Deviation .127
Cross-price Elasticity of the Cross Product-DPT
NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor
.079 dollars per e-cigarette puffs
Standard Deviation .111
Cross-price Elasticity of the Cross Product-DPT
NJOY Ace 6.0% Nicotine ECIG - Menthol Flavor
.098 dollars per e-cigarette puffs
Standard Deviation .141
Cross-price Elasticity of the Cross Product-DPT
NJOY Ace 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor
.202 dollars per e-cigarette puffs
Standard Deviation .122

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Caroline Cobb

Virginia Commonwealth University

Phone: (804) 827-3562

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place