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NCT04709471 · ClinicalTrials.gov registry record · Phase 2
E-cigarette Nicotine Study
A Phase 2 study of Nicotine Dependence and Cigarette Smoking, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT04709471: Completed Phase 2 study of Nicotine Dependence and Cigarette Smoking, sponsored by University of Vermont.
NCT04709471 is a Phase 2 study of Nicotine Dependence and Cigarette Smoking that has completed, run by University of Vermont. The registered enrollment target is 77 participants, below the 186-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04709471, a Phase 2 study of Nicotine Dependence and Cigarette Smoking, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B) abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The investigators adapted a protocol used in a prior study to assign participants to switch to ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the investigators will provide all participants with ENDS pods during the study period and instruct them to only use ENDS provided by the study. Participants in reduced nicotine condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL) pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5% nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week. Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as usual.
Primary Outcome
The investigators will assess compliance with study e-cigarettes and compare the percent non-study e-cigarette use between conditions to determine which behavior-changing strategy is more feasible.
Conditions Studied
Interventions
- DRUG Nicotine
- DEVICE Juul e-cigarette
- BEHAVIORAL Reduction
Study Locations (1)
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2022-06-01 |
| Phase | Phase 2 |
What the finished NCT04709471 record still lists
NCT04709471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 186-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (59% lower).
The record links to 3 conditions, with Nicotine Dependence appearing as the primary indexed condition, and to 3 interventions - of which Nicotine is the first listed.
NCT04709471 reports a single indexed study location in Vermont.
Frequently Asked Questions
What is clinical trial NCT04709471 about?
NCT04709471 is a clinical study titled "E-cigarette Nicotine Study". This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot...
What is the current status of trial NCT04709471?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2021-01-20. Estimated completion is 2022-06-01.
What conditions does trial NCT04709471 study?
This clinical trial studies the following conditions: Nicotine Dependence, Cigarette Smoking, Electronic Cigarette Use.
What interventions are being tested in trial NCT04709471?
The interventions under investigation include: Nicotine (DRUG), Juul e-cigarette (DEVICE), Reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT04709471?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04709471 being conducted?
This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04709471's enrollment target sits among peer trials
77 43rd of 67 higher than 25 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.
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