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NicotineNCT05864586

Developing E-liquid Product Standards (Sweet Spot Study)

A study testing Vaping study EC A, Vaping study EC B and Vaping study EC C in people with Nicotine and Nicotine Vaping, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Nicotine, Nicotine Vaping, E-cigarette Use
What is being tested?
Vaping study EC A, Vaping study EC B and Vaping study EC C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
30 May 2023to 26 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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.

Being tested
Vaping study EC A, Vaping study EC B, Vaping study EC C, Vaping study EC D, Vaping study EC E
Medical subject headings
Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaping study EC ABehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC BBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC CBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC DBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC EBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC FBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC GBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC HBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC IBehavioural

    Vaping two puffs using the study EC device

  • Vaping study EC JBehavioural

    Vaping two puffs using the study EC device

Study groups in NCT05864586
Study groupRoleWhat they receive
Young adult EC usersActive comparatorYoung Adult EC users
Receives: 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
Older adult smokersActive comparatorAdult smokers
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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)
  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start30 May 2023
  3. Primary completion26 Feb 2024
  4. Study completion26 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864586
Sponsor's protocol ID
OSU-22253
Other IDs
NCI-2023-03206
Status last verified
Mar 2025
First submitted
9 May 2023
Last updated
10 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37699050

Questions about this trial

What is this clinical trial studying?

A study testing Vaping study EC A, Vaping study EC B and Vaping study EC C in people with Nicotine and Nicotine Vaping, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral Intentions for Continued Use (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05864586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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