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NCT04084210 · ClinicalTrials.gov registry record · Phase 2
Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 209
- Enrollment target
NCT04084210: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT04084210 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 209 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04084210, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 209 participants
- Enrollment target
Study Summary
The goal of this research is to understand the potential impact of two new FDA strategies to ensure the availability of safer Alternative Nicotine Delivery Systems (ANDS) and to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, this research will examine how well ANDS and very low nicotine cigarettes (VLNCs) can work alone or in combination with the current strategy of providing a safe source of nicotine via nicotine replacement medications to reduce use of combustible cigarettes, in real-world settings. The investigators will enroll 180 daily adult smokers who are not planning to quit smoking within the next 30 days into this mixed design study. Participants will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNC cigarettes; 2) Juul e-cigarettes (with nicotine); or 3) no alternative product. Participants receiving an alternative product (VLNC or e-cigarettes) will be asked to use it for 4 weeks (Weeks 1 through 4). During Weeks 2 and 4 all participants will be asked to switch from their cigarettes to use only study products (i.e., Juul e-cigarettes, VLNCs, or no alternative product) and to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order. During Weeks 1 through 4, participants will use a smartphone to record, in the moment, each time they use their own cigarettes or any alternative product. For a random daily subset of use events, participants will complete additional questions about the internal and external context of their use (e.g., affect, any restrictions on smoking) and their response to use (e.g., withdrawal alleviation, taste, satisfaction). Using these data, the investigators will also examine the effects of these products on the rewarding value of smoking and possible mechanisms driving such behavior (e.g., withdrawal alleviation, satisfaction, taste). This research will provide critical info
Primary Outcome
The mean number of conventional cigarettes smoked during each Switch Week will be used as a measure for conventional cigarette usage.
Interventions
- OTHER Placebo Patch
- DEVICE Juul Electronic cigarette
- OTHER Very Low Nicotine Cigarettes
- DRUG Active Nicotine Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2022-05-23 |
| Phase | Phase 2 |
What the finished NCT04084210 record still lists
NCT04084210 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo Patch is the first listed.
NCT04084210 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04084210 about?
NCT04084210 is a clinical study titled "Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use". The goal of this research is to understand the potential impact of two new FDA strategies to ensure the availability of safer Alternative Nicotine Delivery Systems (ANDS) and to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, this research will examine ho...
What is the current status of trial NCT04084210?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 209 participants. The study started on 2020-09-09. Estimated completion is 2022-05-23.
What interventions are being tested in trial NCT04084210?
The interventions under investigation include: Placebo Patch (OTHER), Juul Electronic cigarette (DEVICE), Very Low Nicotine Cigarettes (OTHER), Active Nicotine Patch (DRUG).
Who is sponsoring clinical trial NCT04084210?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04084210's enrollment target sits among peer trials
209 294th of 2000 higher than 1,707 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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