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NCT03243630 · ClinicalTrials.gov registry record · Early Phase 1

Effects of Flavors on Nicotine Reinforcement in Smokers

A Early Phase 1 study, sponsored by Yale University.

Completed
Registry status
Early Phase 1
Development phase
26
Enrollment target

NCT03243630: Completed Early Phase 1 study, sponsored by Yale University.

NCT03243630 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 26 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03243630, a Early Phase 1 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Early Phase 1
Development phase
26 participants
Enrollment target

Study Summary

To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously. The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ).

Primary Outcome

The (DEQ) Drug Effects Questionnaire has eleven questions with a minimum score of 0 to a maximum score of 100. Peak values from each time points were calculated for the change in the intensity of positive subjective effects as measured with these peak values for like and want more were averaged to obtain a summary score to represent the feel "good drug effects" composite factor. Higher scores for each DEQ represent greater endorsement of that subjective effect (e.g., on the "like drug" scale a

Interventions

  • DRUG IV nicotine
  • DRUG Menthol flavor
  • DRUG green apple
  • DRUG green apple and menthol

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2018-04-23
Est. Completion 2019-01-31
Phase Early Phase 1
Yale University

1,492 total trials

What the finished NCT03243630 record still lists

NCT03243630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower).

The record links to 0 conditions, and to 4 interventions - of which IV nicotine is the first listed.

NCT03243630 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03243630 about?

NCT03243630 is a clinical study titled "Effects of Flavors on Nicotine Reinforcement in Smokers". To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously. The...

What is the current status of trial NCT03243630?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2018-04-23. Estimated completion is 2019-01-31.

What interventions are being tested in trial NCT03243630?

The interventions under investigation include: IV nicotine (DRUG), Menthol flavor (DRUG), green apple (DRUG), green apple and menthol (DRUG).

Who is sponsoring clinical trial NCT03243630?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03243630's enrollment target sits among peer trials

26 977th of 2000 higher than 1,002 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03243630, the US trial registry maintained by the National Library of Medicine. NCT03243630 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.