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Nicotine DependencePhase 1NCT03168191

Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

A Phase 1 study testing Nicotine, Experimental Flavor and Menthol 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
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Trial summary

This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. Read more about this study

Who is it for?
Ages 18 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Nicotine Dependence
What is being tested?
Nicotine, Experimental Flavor and Menthol Flavor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
2 May 2017to 25 Feb 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages 18-20 years
  • Able to read and write
  • Urine cotinine levels of >250 ng/ml at screening appointment
  • Use of e-cigarettes in the past month
  • May or may not currently smoke traditional cigarettes

Who cannot join

  • Seeking smoking cessation treatment
  • Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
  • Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
  • Current or past history of psychosis or other psychiatric diagnosis such as major depression
  • Any significant current medical condition

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CMHC, Substance Abuse Center

    New Haven, Connecticut, 06519

Other trials in United States

About this study

This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.

Being tested
Nicotine, Experimental Flavor, Menthol 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.

  • NicotineDrug

    Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

  • Experimental FlavorOther

    Experimental fruit flavored e-cigarette for lab session

  • Menthol FlavorOther

    Menthol flavored e-cigarette for lab session

Study groups in NCT03168191
Study groupRoleWhat they receive
E-cigarette flavorExperimentalIn this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.
Receives: Drug: Nicotine; Other: Experimental Flavor
Menthol FlavorExperimentalIn this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.
Receives: Drug: Nicotine; Other: Menthol Flavor
No FlavorPlacebo comparatorIn this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.
Receives: Drug: Nicotine

What is being measured

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

  1. Change score in Liking/wanting of the e-cigarette

    The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

Secondary outcomes (9)

  1. Change score in rating of coolness

    gMLS rating of e-cigarette coolness

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

  2. Change score in rating of harshness/irritation

    gMLS rating of e-cigarette harshness/irritation

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

  3. Change score in rating of sweetness

    gMLS rating of e-cigarette sweetness

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

  4. Change score in rating of sourness

    gMLS rating of e-cigarette sourness

    Measured: End of lab session (+40 minutes)

  5. Change score in rating of fruitiness

    gMLS rating of e-cigarette fruitiness

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

  6. Change score in rating of total sensation

    gMLS rating of e-cigarette total sensation

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

  7. E-cigarette value

    Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

  8. Number of puffs

    Number of puffs taken at the end of the ad-lib vaping period

    Measured: End of ad-lib lab session 4 (+40 minutes)

  9. Change score in Tobacco Craving

    The Brief Questionnaire on Smoking Urges (Tiffany \& Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session

    Measured: Baseline (+10 minutes) to end of lab session (+40 minutes)

Timeline

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

  1. First posted30 May 2017
  2. Study start2 May 2017
  3. Primary completion22 Aug 2018
  4. Study completion25 Feb 2019

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168191
Sponsor's protocol ID
1307012312-2
Status last verified
Apr 2020
First submitted
27 Apr 2017
Last updated
4 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jackson A, Green B, Erythropel HC, Kong G, Cavallo DA, Eid T, Gueorguieva R, Buta E, O'Malley SS, Krishnan-Sarin S. Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users. Exp Clin Psychopharmacol. 2021 Aug;29(4):355-365. doi: 10.1037/pha0000368. Epub 2020 Apr 16.

    PubMed 32297782

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nicotine, Experimental Flavor and Menthol 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 5 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 4 May 2020. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change score in Liking/wanting of the e-cigarette (time frame: Baseline (+10 minutes) to end of lab session (+40 minutes)). 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 NCT03168191, 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 4 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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