NCT05864586

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

May 9, 2023

Results QC Date

January 17, 2025

Last Update Submit

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 COMPARATOR

Young Adult EC users

Behavioral: Vaping study EC ABehavioral: Vaping study EC BBehavioral: Vaping study EC CBehavioral: Vaping study EC DBehavioral: Vaping study EC EBehavioral: Vaping study EC FBehavioral: Vaping study EC GBehavioral: Vaping study EC HBehavioral: Vaping study EC IBehavioral: Vaping study EC J

Older adult smokers

ACTIVE COMPARATOR

Adult smokers

Behavioral: Vaping study EC ABehavioral: Vaping study EC BBehavioral: Vaping study EC CBehavioral: Vaping study EC DBehavioral: Vaping study EC EBehavioral: Vaping study EC FBehavioral: Vaping study EC GBehavioral: Vaping study EC HBehavioral: Vaping study EC IBehavioral: Vaping study EC J

Interventions

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Vaping two puffs using the study EC device

Older adult smokersYoung adult EC users

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Related Links

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Results Point of Contact

Title
Dr. Theodore L. Wagener
Organization
OhioSUCCC

Study Officials

  • Theodore L Wagener, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations