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COMPLETED Phase 2

Quit Smoking Study for People Who Use E-Cigarettes

NCT04946825 · View on ClinicalTrials.gov ↗

Study Summary

The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). The investigators will recruit participants using national advertising strategies. All treatment will be provided remotely in order to increase treatment access and comply with current COVID-19 restrictions.

Interventions

  • DRUG Nicotine replacement therapy patch
  • DRUG Nicotine replacement therapy lozenge
  • BEHAVIORAL Quit electronic cigarettes
  • BEHAVIORAL Continue electronic cigarettes

Study Locations (1)

Vermont

  • University of Vermont — Burlington

Trial Details

FieldValue
Enrollment Target 396 participants
Start Date 2021-06-27
Est. Completion 2023-10-25
Phase Phase 2

Sponsor

University of Vermont

107 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04946825

The ClinicalTrials.gov registry entry for NCT04946825 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 107 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Nicotine Addiction appearing as the primary indexed condition, and to 4 interventions — of which Nicotine replacement therapy patch is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04946825 reports 1 study location spanning 1 distinct geographic area — top geographies include Vermont. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04946825 about?

NCT04946825 is a clinical study titled "Quit Smoking Study for People Who Use E-Cigarettes". The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a...

What is the current status of trial NCT04946825?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 396 participants. The study started on 2021-06-27. Estimated completion is 2023-10-25.

What conditions does trial NCT04946825 study?

This clinical trial studies the following conditions: Nicotine Addiction, E-Cig Use, Quitting Smoking. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04946825?

The interventions under investigation include: Nicotine replacement therapy patch (DRUG), Nicotine replacement therapy lozenge (DRUG), Quit electronic cigarettes (BEHAVIORAL), Continue electronic cigarettes (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04946825?

This trial is sponsored by University of Vermont, which has 107 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04946825 being conducted?

This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial