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NCT03559725 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes
A Phase 1 study, sponsored by 22nd Century Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT03559725: Completed Phase 1 study, sponsored by 22nd Century Group.
NCT03559725 is a Phase 1 study that has completed, run by 22nd Century Group. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03559725, a Phase 1 study, has completed, sponsored by 22nd Century Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.
Primary Outcome
The maximum reduction in Visual Analog Scale (VAS) score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B.
Interventions
- DRUG Nicotine gum (C)
- OTHER VLN menthol cigarettes (A)
- OTHER Usual Brand Menthol Cigarettes (B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2018-10-04 |
| Phase | Phase 1 |
What the finished NCT03559725 record still lists
NCT03559725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Nicotine gum (C) is the first listed.
NCT03559725 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03559725 about?
NCT03559725 is a clinical study titled "Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes". This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.
What is the current status of trial NCT03559725?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2018-05-01. Estimated completion is 2018-10-04.
What interventions are being tested in trial NCT03559725?
The interventions under investigation include: Nicotine gum (C) (DRUG), VLN menthol cigarettes (A) (OTHER), Usual Brand Menthol Cigarettes (B) (OTHER).
Who is sponsoring clinical trial NCT03559725?
This trial is sponsored by 22nd Century Group, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03559725's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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