Developing E-liquid Product Standards (Sweet Spot Study)
Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers
2 other identifiers
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2024
CompletedResults Posted
Study results publicly available
April 10, 2025
CompletedApril 10, 2025
March 1, 2025
9 months
May 9, 2023
January 17, 2025
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Subjective Appeal
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.
Study Arms (2)
Young adult EC users
ACTIVE COMPARATORYoung Adult EC users
Older adult smokers
ACTIVE COMPARATORAdult smokers
Interventions
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Vaping two puffs using the study EC device
Eligibility Criteria
You may qualify if:
- Young adult e-cigarette user or older adult smoker
- Willing to abstain from all nicotine product use for 12 hours prior to the study visit
- Read and speak English
You may not qualify if:
- Currently attempting to quit nicotine products
- Currently pregnant, planning to become pregnant, or breastfeeding
- Current or past use of tobacco products other than e-cigarettes or cigarettes
- Self-reported diagnosis of lung disease
- Self-reported new or unstable cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Cho YJ, Brinkman MC, Hinton A, Nshimiyimana JD, Mehta T, Adeniji A, Norton K, El Hellani A, Wagener TL. The sweet spot study-Developing e-liquid product standards for nicotine form and concentration to improve public health: Protocol for a randomized, double-blinded, crossover study. PLoS One. 2023 Sep 12;18(9):e0291522. doi: 10.1371/journal.pone.0291522. eCollection 2023.
PMID: 37699050DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Theodore L. Wagener
- Organization
- OhioSUCCC
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore L Wagener, PhD
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2023
First Posted
May 18, 2023
Study Start
May 30, 2023
Primary Completion
February 26, 2024
Study Completion
February 26, 2024
Last Updated
April 10, 2025
Results First Posted
April 10, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share