The Interaction of Flavor With Nicotine Form in Adult Smokers

Phase 1

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Nicotine form; Other: E-cigarette experimental flavor

• Registration Number: NCT04262817
• Lead Sponsor: Yale University

Brief Summary

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Study Start: 2020-11-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-02-02
• Results First Submitted: 2023-01-10
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-01
• Last Update Submitted: 2023-05-01
• Results First Posted: 2023-05-26
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• At least 21 years old, able to read and write, use of combustible

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Exclusion Criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E-cigarette flavor	Nicotine form	In this arm, participants will receive two experimental e-cigarette flavors
E-cigarette nicotine form	Nicotine form	In this arm, participants will receive two forms of nicotine in an e-cigarette
E-cigarette flavor	E-cigarette experimental flavor	In this arm, participants will receive two experimental e-cigarette flavors
E-cigarette nicotine form	E-cigarette experimental flavor	In this arm, participants will receive two forms of nicotine in an e-cigarette

Primary Outcome Measures

Name	Time	Method
Changes in Liking of E-cigarette Overall	up to 3 weeks	Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Changes in Liking of E-cigarette Flavor	up to 3 weeks	Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.

Secondary Outcome Measures

Name	Time	Method
gLMS: Irritation	up to 3 weeks	Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Number of Puffs	up to 3 weeks	The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed.
gLMS: Sweetness	up to 3 weeks	Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
gLMS: Coolness	up to 3 weeks	Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).

Trial Locations

Locations (1)

Pierce Laboratory; 🇺🇸 New Haven, Connecticut, United States