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NCT04210180 · ClinicalTrials.gov registry record · Phase 2

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

A Phase 2 study, sponsored by Rose Research Center.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT04210180: Completed Phase 2 study, sponsored by Rose Research Center.

NCT04210180 is a Phase 2 study that has completed, run by Rose Research Center. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04210180, a Phase 2 study, has completed, sponsored by Rose Research Center.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

This open-label study will explore the impact of varenicline on the process of switching from combustible cigarettes (CC) to an e-cigarette. Varenicline is currently the most efficacious single pharmacotherapy for smoking cessation, and through its actions as an agonist or partial agonist at various nicotinic acetylcholine receptor subtypes, serves to diminish the rewarding effects of cigarette smoking. Diminishing the rewarding effects of smoking might facilitate the transition from CC to e-cigarettes. On the other hand, varenicline might attenuate the rewarding effects of nicotine-containing e-cigarettes as well, which could hamper the transition. Thus, the study will provide important information about the actions of varenicline on CC as well as e-cigarettes. There is no therapeutic intent in that smokers' nicotine/tobacco dependence will not be treated; the goal is to switch from one form of nicotine/tobacco dependence (CC) to dependence on a different tobacco product (e-cigarettes).

Primary Outcome

The primary switching outcome will be smoking abstinence during weeks 8-11 post-switching date. Complete switching from combustible cigarette use at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session.

Interventions

  • DRUG Varenicline
  • OTHER e-cigarette

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2019-11-19
Est. Completion 2021-03-22
Phase Phase 2
Rose Research Center

11 total trials

What the finished NCT04210180 record still lists

NCT04210180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Varenicline is the first listed.

NCT04210180 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04210180 about?

NCT04210180 is a clinical study titled "Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction". This open-label study will explore the impact of varenicline on the process of switching from combustible cigarettes (CC) to an e-cigarette. Varenicline is currently the most efficacious single pharmacotherapy for smoking cessation, and through its actions as an agonist or partial agonist at various...

What is the current status of trial NCT04210180?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2019-11-19. Estimated completion is 2021-03-22.

What interventions are being tested in trial NCT04210180?

The interventions under investigation include: Varenicline (DRUG), e-cigarette (OTHER).

Who is sponsoring clinical trial NCT04210180?

This trial is sponsored by Rose Research Center, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04210180's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 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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Source: ClinicalTrials.gov NCT04210180, the US trial registry maintained by the National Library of Medicine. NCT04210180 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.