Developing E-liquid Product Standards (Sweet Spot Study)

Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers

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 Overview

• Status: Completed
• Conditions: Nicotine; Nicotine Vaping; E-cigarette Use
• Intervention / Treatment: Behavioral: Vaping study EC A; Behavioral: Vaping study EC B; Behavioral: Vaping study EC C; Behavioral: Vaping study EC D; Behavioral: Vaping study EC E; Behavioral: Vaping study EC F; Behavioral: Vaping study EC G; Behavioral: Vaping study EC H; Behavioral: Vaping study EC I; Behavioral: Vaping study EC J

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Young adult EC users; Young Adult EC users	Behavioral: Vaping study EC A; Vaping two puffs using the study EC device; Behavioral: Vaping study EC B; Vaping two puffs using the study EC device; Behavioral: Vaping study EC C; Vaping two puffs using the study EC device; Behavioral: Vaping study EC D; Vaping two puffs using the study EC device; Behavioral: Vaping study EC E; Vaping two puffs using the study EC device; Behavioral: Vaping study EC F; Vaping two puffs using the study EC device; Behavioral: Vaping study EC G; Vaping two puffs using the study EC device; Behavioral: Vaping study EC H; Vaping two puffs using the study EC device; Behavioral: Vaping study EC I; Vaping two puffs using the study EC device; Behavioral: Vaping study EC J; Vaping two puffs using the study EC device
Active Comparator: Older adult smokers; Adult smokers	Behavioral: Vaping study EC A; Vaping two puffs using the study EC device; Behavioral: Vaping study EC B; Vaping two puffs using the study EC device; Behavioral: Vaping study EC C; Vaping two puffs using the study EC device; Behavioral: Vaping study EC D; Vaping two puffs using the study EC device; Behavioral: Vaping study EC E; Vaping two puffs using the study EC device; Behavioral: Vaping study EC F; Vaping two puffs using the study EC device; Behavioral: Vaping study EC G; Vaping two puffs using the study EC device; Behavioral: Vaping study EC H; Vaping two puffs using the study EC device; Behavioral: Vaping study EC I; Vaping two puffs using the study EC device; Behavioral: Vaping study EC J; Vaping two puffs using the study EC device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Theodore L Wagener, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: OSU-22253; NCI-2023-03206 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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