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NCT02590393 · ClinicalTrials.gov registry record · Phase 1
The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
A Phase 1 study of Nicotine Dependence, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02590393: Completed Phase 1 study of Nicotine Dependence, sponsored by Duke University.
NCT02590393 is a Phase 1 study of Nicotine Dependence that has completed, run by Duke University. The registered enrollment target is 20 participants, below the 186-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02590393, a Phase 1 study of Nicotine Dependence, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.
Primary Outcome
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on expired air carbon monoxide readings.
Conditions Studied
Interventions
- COMBINATION_PRODUCT E-cigarettes
Study Locations (1)
North Carolina
- Duke Center for Smoking Cessation - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2022-01-13 |
| Phase | Phase 1 |
What the finished NCT02590393 record still lists
NCT02590393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 186-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 1 intervention - of which E-cigarettes is the first listed.
NCT02590393 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02590393 about?
NCT02590393 is a clinical study titled "The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence". The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have be...
What is the current status of trial NCT02590393?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-05-21. Estimated completion is 2022-01-13.
What conditions does trial NCT02590393 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT02590393?
The interventions under investigation include: E-cigarettes (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT02590393?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02590393 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine Dependence
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 NCT02590393's enrollment target sits among peer trials
20 56th of 67 higher than 11 of 67 other Nicotine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nicotine Dependence 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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