Nicotine DependencePhase 1NCT04262817

The Interaction of Flavor With Nicotine Form in Adult Smokers

A Phase 1 study testing Nicotine form and E-cigarette experimental flavor in people with Nicotine Dependence, run by Yale University 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

Search all trials

Trial summary

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Nicotine Dependence
What is being tested?: Nicotine form and E-cigarette experimental flavor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2020to 2 Feb 2022
Phase: Phase 1
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At least 21 years old, able to read and write, use of combustible

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Pierce Laboratory
New Haven, Connecticut, 06519

Other trials in United States

About this study

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

Conditions: Nicotine Dependence
Being tested: Nicotine form, E-cigarette experimental flavor
Medical subject headings: Tobacco Use Disorder

What participants receive

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

Nicotine formDrug
participants will receive 36mg/ml nicotine salt and freebase nicotine
E-cigarette experimental flavorOther
Participants will receive menthol and tobacco flavored e-cigarettes

Study groups in NCT04262817
Study group	Role	What they receive
E-cigarette flavor	Experimental	In this arm, participants will receive two experimental e-cigarette flavors Receives: Drug: Nicotine form; Other: E-cigarette experimental flavor
E-cigarette nicotine form	Experimental	In this arm, participants will receive two forms of nicotine in an e-cigarette Receives: Drug: Nicotine form; Other: E-cigarette experimental flavor

What is being measured

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

Changes in Liking of E-cigarette Overall
Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Measured: up to 3 weeks
Changes in Liking of E-cigarette Flavor
Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Measured: up to 3 weeks

Secondary outcomes (4)

gLMS: Sweetness
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Measured: up to 3 weeks
gLMS: Coolness
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Measured: up to 3 weeks
gLMS: Irritation
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Measured: up to 3 weeks
Number of Puffs
The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed.
Measured: up to 3 weeks

Timeline

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

1 Nov 20202 Feb 2022

First posted10 Feb 2020
Study start1 Nov 2020
Primary completion10 Jan 2022
Study completion2 Feb 2022

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.
Other trials for Nicotine DependenceStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04262817
Sponsor's protocol ID: 2000025687
Other IDs: 2U54DA036151-06, 1K01DA051882-01
Status last verified: May 2023
First submitted: 4 Feb 2020
Last updated: 26 May 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

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?

See locations

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Interaction of Flavor With Nicotine Form in Adult Smokers
ClinicalTrials.gov ID: NCT04262817
Acronym / sponsor ID: 2000025687
Conditions: Nicotine Dependence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Nov 2020 (actual)
Primary completion: 10 Jan 2022 (actual)
Study completion: 2 Feb 2022 (actual)
First posted: 10 Feb 2020 (actual)
Results: Posted 26 May 2023

Clinical summary

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

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
E-cigarette flavor	Experimental	Drug: Nicotine form, Other: E-cigarette experimental flavorIn this arm, participants will receive two experimental e-cigarette flavors
E-cigarette nicotine form	Experimental	Drug: Nicotine form, Other: E-cigarette experimental flavorIn this arm, participants will receive two forms of nicotine in an e-cigarette

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

At least 21 years old, able to read and write, use of combustible

Key exclusion criteria (1 listed)

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
Nicotine formparticipants will receive 36mg/ml nicotine salt and freebase nicotine	Drug	E-cigarette flavor, E-cigarette nicotine form
E-cigarette experimental flavorParticipants will receive menthol and tobacco flavored e-cigarettes	Other	E-cigarette flavor, E-cigarette nicotine form

Primary outcome

Changes in Liking of E-cigarette Overall
Time frame: up to 3 weeks
Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Changes in Liking of E-cigarette Flavor
Time frame: up to 3 weeks
Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.

4 secondary outcomes

gLMS: Sweetness
Time frame: up to 3 weeks
gLMS: Coolness
Time frame: up to 3 weeks
gLMS: Irritation
Time frame: up to 3 weeks
Number of Puffs
Time frame: up to 3 weeks

Results and safety

Results posted to the registry on 26 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	16	16

Primary outcome: Changes in Liking of E-cigarette Overall

Time frame: up to 3 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Overall Participants n = 16
Nicotine Salt	14.2 (6.0)
Freebase Nicotine	5.3 (6.6)
Menthol Flavor	11.9 (7.0)
Tobacco Flavor	2.2 (6.2)

Overall Participants: p = 0.01, Mixed Models Analysis
Overall Participants: p = 0.34, Mixed Models Analysis

Population analysed: Participants that enrolled and participated in the overall study.

Primary outcome: Changes in Liking of E-cigarette Flavor

Time frame: up to 3 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Overall Participants n = 16
Nicotine Salt	4.1 (4.6)
Freebase Nicotine	0.0 (6.5)
Menthol Flavor	6.3 (5.7)
Tobacco Flavor	2.2 (6.2)

Overall Participants: p = 0.38, Mixed Models Analysis
Overall Participants: p = 0.85, Mixed Models Analysis

Population analysed: Participants that enrolled and participated in the overall study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Form: Nicotine Salt	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Nicotine Form: Freebase Nicotine	0 of 16 (0%)	0 of 16 (0%)	0 of 16
E-cigarette Experimental Flavor: Menthol	0 of 16 (0%)	0 of 16 (0%)	0 of 16
E-cigarette Experimental Flavor: Tobacco	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nicotine Dependence

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nicotine form and E-cigarette experimental flavor in people with Nicotine Dependence, run by Yale University 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 1 inclusion and 1 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 26 May 2023. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2023). 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?

Changes in Liking of E-cigarette Overall (time frame: up to 3 weeks). The study lists 2 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 NCT04262817.

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 26 May 2023.