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
Type of treatment: Lifestyle or therapy programme
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

Conditions: Nicotine, Nicotine Vaping, E-cigarette Use
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 group	Role	What they receive
Young adult EC users	Active comparator	Young 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 smokers	Active comparator	Adult 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.

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.
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.
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)

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.

30 May 202326 Feb 2024

First posted18 May 2023
Study start30 May 2023
Primary completion26 Feb 2024
Study completion26 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NicotineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Nicotine trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers
ClinicalTrials.gov ID: NCT05864586
Acronym / sponsor ID: OSU-22253
Conditions: Nicotine, Nicotine Vaping, E-cigarette Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Study start: 30 May 2023 (actual)
Primary completion: 26 Feb 2024 (actual)
Study completion: 26 Feb 2024 (actual)
First posted: 18 May 2023 (actual)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Young adult EC users	Active comparator	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 JYoung Adult EC users
Older adult smokers	Active comparator	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 JAdult smokers

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaping study EC AVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC BVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC CVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC DVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC EVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC FVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC GVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC HVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC IVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users
Vaping study EC JVaping two puffs using the study EC device	Behavioural	Older adult smokers, Young adult EC users

Primary outcome

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.
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.
Intensity of Sensory Attributes
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.
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
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.
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.

1 secondary outcome

Subjective Appeal
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.

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Young Adult EC Users	70	66
Older Adult Smokers	80	66

Primary outcome: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	Young Adult EC Users - 20mg/mL, 5% Free-base n = 66	Young Adult EC Users - 20mg/mL, 25% Free-base n = 66	Young Adult EC Users - 20mg/mL, 45% Free-base n = 66	Young Adult EC Users - 20mg/mL, 65% Free-base n = 66	Young Adult EC Users - 20mg/mL, 85% Free-base n = 66	Young Adult EC Users - 50mg/mL, 5% Free-base n = 66	Young Adult EC Users - 50mg/mL, 25% Free-base n = 66	Young Adult EC Users - 50mg/mL, 45% Free-base n = 66	Young Adult EC Users - 50mg/mL, 65% Free-base n = 66	Young Adult EC Users - 50mg/mL, 85% Free-base n = 66	Older Adult Smokers - 20mg/mL, 5% Free-base n = 67	Older Adult Smokers - 20mg/mL, 25% Free-base n = 66	Older Adult Smokers - 20mg/mL, 45% Free-base n = 66	Older Adult Smokers - 20mg/mL, 65% Free-base n = 66	Older Adult Smokers - 20mg/mL, 85% Free-base n = 67	Older Adult Smokers - 50mg/mL, 5% Free-base n = 66	Older Adult Smokers - 50mg/mL, 25% Free-base n = 66	Older Adult Smokers - 50mg/mL, 45% Free-base n = 66	Older Adult Smokers - 50mg/mL, 65% Free-base n = 66	Older Adult Smokers - 50mg/mL, 85% Free-base n = 66
Try Product Again	3.73 (2.01)	3.88 (1.93)	3.91 (1.86)	3.74 (1.79)	3.55 (1.93)	3.74 (1.98)	2.95 (1.86)	3.00 (1.74)	2.35 (1.52)	1.94 (1.38)	3.85 (2.06)	3.70 (1.97)	3.44 (1.92)	3.80 (2.04)	2.88 (1.83)	3.44 (1.76)	3.03 (1.93)	2.74 (1.78)	2.24 (1.61)	2.20 (1.64)
Purchase Product for Regular Use	2.86 (1.85)	2.95 (1.80)	2.98 (1.69)	2.71 (1.71)	2.70 (1.77)	2.64 (1.73)	2.29 (1.76)	2.09 (1.38)	1.64 (1.25)	1.52 (1.14)	3.21 (1.94)	3.06 (1.98)	3.03 (1.98)	3.11 (2.04)	2.42 (1.74)	2.92 (1.78)	2.47 (1.73)	2.15 (1.60)	1.91 (1.49)	1.74 (1.33)
Use Product Regularly	2.83 (1.81)	3.12 (1.88)	3.05 (1.77)	2.76 (1.70)	2.77 (1.80)	2.71 (1.79)	2.27 (1.71)	2.03 (1.37)	1.74 (1.27)	1.52 (1.27)	3.09 (2.00)	3.02 (1.99)	2.79 (1.90)	2.97 (2.09)	2.36 (1.74)	2.85 (1.76)	2.44 (1.81)	2.14 (1.65)	1.85 (1.37)	1.76 (1.35)

Primary outcome: Intensity of Sensory Attributes

Measure	Young Adult EC Users - 20mg/mL, 5% Free-base n = 66	Young Adult EC Users - 20mg/mL, 25% Free-base n = 66	Young Adult EC Users - 20mg/mL, 45% Free-base n = 66	Young Adult EC Users - 20mg/mL, 65% Free-base n = 66	Young Adult EC Users - 20mg/mL, 85% Free-base n = 66	Young Adult EC Users - 50mg/mL, 5% Free-base n = 66	Young Adult EC Users - 50mg/mL, 25% Free-base n = 66	Young Adult EC Users - 50mg/mL, 45% Free-base n = 66	Young Adult EC Users - 50mg/mL, 65% Free-base n = 66	Young Adult EC Users - 50mg/mL, 85% Free-base n = 66	Older Adult Smokers - 20mg/mL, 5% Free-base n = 67	Older Adult Smokers - 20mg/mL, 25% Free-base n = 66	Older Adult Smokers - 20mg/mL, 45% Free-base n = 66	Older Adult Smokers - 20mg/mL, 65% Free-base n = 66	Older Adult Smokers - 20mg/mL, 85% Free-base n = 67	Older Adult Smokers - 50mg/mL, 5% Free-base n = 66	Older Adult Smokers - 50mg/mL, 25% Free-base n = 66	Older Adult Smokers - 50mg/mL, 45% Free-base n = 66	Older Adult Smokers - 50mg/mL, 65% Free-base n = 66	Older Adult Smokers - 50mg/mL, 85% Free-base n = 66
Throat Hit	13.05 (13.09)	13.03 (11.66)	16.17 (15.00)	17.53 (15.83)	21.29 (16.80)	19.39 (14.46)	32.97 (22.04)	36.20 (24.04)

Primary outcome: Degree of Liking or Disliking of Sensations

Measure	Young Adult EC Users - 20mg/mL, 5% Free-base n = 65	Young Adult EC Users - 20mg/mL, 25% Free-base n = 66	Young Adult EC Users - 20mg/mL, 45% Free-base n = 66	Young Adult EC Users - 20mg/mL, 65% Free-base n = 66	Young Adult EC Users - 20mg/mL, 85% Free-base n = 66	Young Adult EC Users - 50mg/mL, 5% Free-base n = 66	Young Adult EC Users - 50mg/mL, 25% Free-base n = 66	Young Adult EC Users - 50mg/mL, 45% Free-base n = 66	Young Adult EC Users - 50mg/mL, 65% Free-base n = 66	Young Adult EC Users - 50mg/mL, 85% Free-base n = 66	Older Adult Smokers - 20mg/mL, 5% Free-base n = 67	Older Adult Smokers - 20mg/mL, 25% Free-base n = 65	Older Adult Smokers - 20mg/mL, 45% Free-base n = 66	Older Adult Smokers - 20mg/mL, 65% Free-base n = 65	Older Adult Smokers - 20mg/mL, 85% Free-base n = 66	Older Adult Smokers - 50mg/mL, 5% Free-base n = 65	Older Adult Smokers - 50mg/mL, 25% Free-base n = 66	Older Adult Smokers - 50mg/mL, 45% Free-base n = 65	Older Adult Smokers - 50mg/mL, 65% Free-base n = 65	Older Adult Smokers - 50mg/mL, 85% Free-base n = 66
Value	8.34 (31.61)	5.33 (33.35)	11.83 (29.47)	5.42 (25.27)	0.05 (28.63)	6.89 (31.31)	-8.82 (37.66)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Single study visit, Up to 3 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Young Adult EC Users	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Older Adult Smokers	0 of 80 (0%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37699050Cho 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.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theodore L Wagener, PhD principal investigator

Ohio State University Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.