Developing E-liquid Product Standards (Sweet Spot Study)

Ohio State University Comprehensive Cancer Center150 enrolled

Overview

The Sweet Spot Study aims to evaluate the effect of e-liquids with nicotine varying in freebase (FB) levels and concentrations on the appeal of electronic cigarettes (ECs) in young adult EC users with minimal/no history of smoking and older adult smokers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Nicotine Nicotine Vaping E-cigarette Use

Interventions

Vaping study EC ABEHAVIORAL

Vaping two puffs using the study EC device

Vaping study EC BBEHAVIORAL

Vaping two puffs using the study EC device

Vaping study EC CBEHAVIORAL

Vaping two puffs using the study EC device

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Young adult e-cigarette user or older adult smoker 2. Willing to abstain from all nicotine product use for 12 hours prior to the study visit 3. Read and speak English Exclusion criteria: 1. Currently attempting to quit nicotine products 2. Currently pregnant, planning to become pregnant, or breastfeeding 3. Current or past use of tobacco products other than e-cigarettes or cigarettes 4. Self-reported diagnosis of lung disease 5. Self-reported new or unstable cardiovascular disease

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Behavioral Intentions for Continued Use

Self-report measure on a 7-point scale completed following e-cigarette self-administration. Ratings range from1 (extremely unlikely) to 7 (extremely likely) with higher scores indicating a higher likelihood of continuing to use the product.

Time frame: The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours.

Intensity of Sensory Attributes

5-item self-report measure completed following e-cigarette self-administration, using the general Labeled Magnitude Scale (gLMS). Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.

Degree of Liking or Disliking of Sensations

Self-report measure completed following e-cigarette self-administration, using the Labeled Hedonic Scale (LHS). Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking.

Secondary Outcomes

Subjective Appeal

12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses to the e-cigarettes. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale.

Data from ClinicalTrials.gov

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