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NCT03559751 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes
A Phase 1 study of Tobacco Use, sponsored by 22nd Century Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03559751: Completed Phase 1 study of Tobacco Use, sponsored by 22nd Century Group.
NCT03559751 is a Phase 1 study of Tobacco Use that has completed, run by 22nd Century Group. The registered enrollment target is 66 participants, below the 378-participant average among 76 other Tobacco Use trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03559751, a Phase 1 study of Tobacco Use, has completed, sponsored by 22nd Century Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the abuse liability of 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.
Conditions Studied
Interventions
- OTHER VLN cigarettes (A)
- OTHER Usual Brand Cigarettes (B)
- DRUG Nicotine gum (C)
Study Locations (1)
Kansas
- Vince & Associates Clinical Research, Inc - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-04-13 |
| Est. Completion | 2018-09-06 |
| Phase | Phase 1 |
What the finished NCT03559751 record still lists
NCT03559751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 378-participant average among 76 other Tobacco Use trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Tobacco Use appearing as the primary indexed condition, and to 3 interventions - of which VLN cigarettes (A) is the first listed.
NCT03559751 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT03559751 about?
NCT03559751 is a clinical study titled "Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes". This study is designed to evaluate the abuse liability of very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes
What is the current status of trial NCT03559751?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2018-04-13. Estimated completion is 2018-09-06.
What conditions does trial NCT03559751 study?
This clinical trial studies the following conditions: Tobacco Use.
What interventions are being tested in trial NCT03559751?
The interventions under investigation include: VLN cigarettes (A) (OTHER), Usual Brand Cigarettes (B) (OTHER), Nicotine gum (C) (DRUG).
Who is sponsoring clinical trial NCT03559751?
This trial is sponsored by 22nd Century Group, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03559751 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Use
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03559751's enrollment target sits among peer trials
66 45th of 76 higher than 31 of 76 other Tobacco Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use 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.
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