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NCT04535362 · ClinicalTrials.gov registry record · Early Phase 1

Nicotine's Potential Abuse With Menthol

A Early Phase 1 study, sponsored by Yale University.

Completed
Registry status
Early Phase 1
Development phase
16
Enrollment target

NCT04535362: Completed Early Phase 1 study, sponsored by Yale University.

NCT04535362 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04535362, a Early Phase 1 study, has completed, sponsored by Yale University.

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

Study Summary

To examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.

Primary Outcome

Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). H

Interventions

  • DRUG Nicotine

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2021-06-28
Est. Completion 2023-06-29
Phase Early Phase 1
Yale University

1,492 total trials

What the finished NCT04535362 record still lists

NCT04535362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which Nicotine is the first listed.

NCT04535362 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04535362 about?

NCT04535362 is a clinical study titled "Nicotine's Potential Abuse With Menthol". To examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.

What is the current status of trial NCT04535362?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2021-06-28. Estimated completion is 2023-06-29.

What interventions are being tested in trial NCT04535362?

The interventions under investigation include: Nicotine (DRUG).

Who is sponsoring clinical trial NCT04535362?

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 NCT04535362's enrollment target sits among peer trials

16 1370th of 2000 higher than 598 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 NCT04535362, the US trial registry maintained by the National Library of Medicine. NCT04535362 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.