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NCT04696380 · ClinicalTrials.gov registry record · Phase 2
Do Flavors Increase the Addiction Potential of Nicotine?
A Phase 2 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT04696380: Completed Phase 2 study, sponsored by University of Vermont.
NCT04696380 is a Phase 2 study that has completed, run by University of Vermont. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04696380, a Phase 2 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The FDA has concluded that flavors (e.g. menthol) are associated with greater addiction potential in tobacco cigarettes (Gottlieb March 13, 2019). Whether the same is true for e-cigarettes and non-menthol flavors is unclear and our study should help answer this question. Our major hypothesis is that the pharmacological effect of nicotine to induce addiction will be greater with use of a preferred e-cigarette flavor than with use of a non-preferred flavor. The pharmacological effect will be measured by how much a larger nicotine dose increases addiction potential compared to a smaller dose.
Primary Outcome
Average of "I feel good e-cigarette effects", "I want more of that e-cigarette I received", "I feel the e-cigarette strength" and "I like the e-cigarette effect" on a 0-100mm scale from "not at all" (0) to "extremely" (100).
Interventions
- DRUG Nicotine
- DEVICE JUUL e-cigarette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 2 |
What the finished NCT04696380 record still lists
NCT04696380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Nicotine is the first listed.
NCT04696380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04696380 about?
NCT04696380 is a clinical study titled "Do Flavors Increase the Addiction Potential of Nicotine?". The FDA has concluded that flavors (e.g. menthol) are associated with greater addiction potential in tobacco cigarettes (Gottlieb March 13, 2019). Whether the same is true for e-cigarettes and non-menthol flavors is unclear and our study should help answer this question. Our major hypothesis is tha...
What is the current status of trial NCT04696380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2021-03-01. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT04696380?
The interventions under investigation include: Nicotine (DRUG), JUUL e-cigarette (DEVICE).
Who is sponsoring clinical trial NCT04696380?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04696380's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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