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Nicotine Regulation for Dual Users of E-cigarettes and Cigarettes
NCT06614504 · View on ClinicalTrials.gov ↗
Study Summary
Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, completely switching from cigarettes to e-cigarettes likely reduces risk for tobacco-related harm. However, many established dual users maintain long-term smoking and the majority who use e-cigarettes non-daily are at an even greater risk for prolonged smoking than exclusive cigarette smokers. The Food and Drug Administration Center for Tobacco Products (FDA CTP) has announced plans to implement a nicotine-limiting product standard, capping the nicotine in cigarettes at a minimally or non-addictive level. Randomized controlled trials (RCTs) demonstrate that adults who exclusively smoke cigarettes respond to very low nicotine content (VLNC) cigarettes with reductions in smoking, demand, and dependence. However, nicotine reduction RCTs to date have excluded people who regularly use e-cigarettes and therefore it remains unclear how a nicotine-limiting standard for cigarettes would affect smoking among dual users. Given the potential substitutability of e-cigarettes for cigarettes, reducing the nicotine in cigarettes could promote a transition to exclusive e-cigarette use among dual users unable to completely quit nicotine, but only if sufficiently appealing e-cigarettes remain available. E-cigarettes containing 5% nicotine-salt solution are currently most popular in the US, but policy makers have proposed restricting e-cigarettes to ≤ 2% nicotine to curb youth e-cigarette use, and several states have already set limits to reduce nicotine in e-cigarettes. Prior laboratory studies indicate that higher vs lower nicotine e-cigarettes serve as better substitutes for cigarettes among adult dual users. As such, a restriction on e-cigarette nicotine concentration could undermine the potenti
Conditions Studied
Interventions
- OTHER Varying the nicotine content of cigarettes
- OTHER Varying the nicotine content of e-cigarettes
Study Locations (2)
Rhode Island
- Brown University — Providence
Vermont
- University of Vermont — Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06614504
The ClinicalTrials.gov registry entry for NCT06614504 describes a study currently listed as recruiting. 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 308 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 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 2 interventions — of which Varying the nicotine content of cigarettes 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: NCT06614504 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Rhode Island, 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 NCT06614504 about?
NCT06614504 is a clinical study titled "Nicotine Regulation for Dual Users of E-cigarettes and Cigarettes". Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, complete...
What is the current status of trial NCT06614504?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2024-11-01. Estimated completion is 2028-09-30.
What conditions does trial NCT06614504 study?
This clinical trial studies the following conditions: Tobacco Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06614504?
The interventions under investigation include: Varying the nicotine content of cigarettes (OTHER), Varying the nicotine content of e-cigarettes (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06614504?
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 NCT06614504 being conducted?
This trial has 2 study locations across Rhode Island, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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