Sensory Perception of Sweet Flavors in E-Cigarette

NCT03332953 | Completed

• 1 other identifier: IRB # 8252
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the explosive popularity of sweet flavored electronic cigarettes, there is little empirical evidence regarding how "sweet" flavors interact with different levels of nicotine to reduce its perceived bitterness and harshness, and thereby increase its appeal and additive potential. This study will serve to fill this knowledge gap through empirical psychophysical data that will determine the association between sweet flavor and nicotine and its link to the acceptance and rejection of vaped nicotine.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Hedonic and Intensity Ratings

  The outcome will be ratings obtained for liking or disliking of the stimulus and ratings for perceived intensities of sensations. These quantitative values collected from the scaling procedure will be analyzed corresponding to the level of nicotine and flavor for the particular stimulus. For rating perceived intensity, we will use the general Labeled Magnitude Scale (gLMS), developed for measurement of the intensity of oral sensation and taste. The scale is bounded by 'no sensation' at the bottom to 'strongest imaginable sensation of any kind' on top, with intermediate ratings between (bottom to top: barely detectable, weak, moderate, strong, very strong). A Labeled Hedonic Scale (LHS) will be used to measure individuals' liking or disliking of the oral sensation. The scale encompasses from "most disliked sensation imaginable" on one end to "most liked sensation imaginable" on the other end, with intermediate hedonic labels (like/dislike: slightly, moderately, very much, extremely).

  Until July 2018

Study Arms (1)

E-cigarette

OTHER

Subjects will be asked to vape various e-cigarettes at three concentrations of nicotine and sweet flavor (9 stimuli per subject). The subject will be asked to make ratings for the overall liking or disliking of the e-cigarette, followed by ratings on perceived intensities of sensations.

Other: E-cigarettes with varying concentrations of nicotine & flavor

Interventions

E-cigarettes with varying concentrations of nicotine & flavor OTHER

Subjects will be asked to vape various e-cigarettes containing e-liquids at three concentrations of nicotine and sweet flavor (9 stimuli per subject).

E-cigarette

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between 18-35 years of age; have been vaping for at least 1 month; currently use an e-cigarette that contains nicotine; have used an e-cigarette with medium (9-12 mg/mL) or high (18 to 36 mg/mL) nicotine strength at some point in their e-cigarette using history.

You may not qualify if:

• Do not have mouth or throat problems that would keep subject from vaping comfortably; do not have health problems that would keep subject from tasting or smelling normally; do not have any food ingredient allergies and have never had an allergic reaction to propylene glycol or vegetable glycerin; do not have any respiratory allergies (i.e., frequent sneezing, nasal congestion, nasal discharge); do not have a history of pulmonary disease or asthma; are not in the process of trying to quit vaping; are not pregnant, breast feeding, or trying to become pregnant.

Sponsors & Collaborators

• Oregon State University: lead

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97330, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Electronic Nicotine Delivery Systems; Flavoring Agents

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Juyun Lim

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: January 21, 2018
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)