Reducing nicotine levels in cigarettes and e-cigarettes for dual users
Official title: A Randomized Controlled Trial of Reduced Nicotine Cigarettes and E-cigarettes Among Dual Users
Run by University of Vermont · NCT06614504 · Data updated 2026-11-12
This study tests if lowering nicotine levels in cigarettes and e-cigarettes can help people who use both cut down on their tobacco use and cravings.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 308 (estimated) |
| Sponsor | University of Vermont Academic / other |
| Locations | 2 sites (Providence, Rhode Island and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | August 31, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT06614504 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 21 and older who regularly use both cigarettes and e-cigarettes.
✕Probably not a fit
Patients who are pregnant, under 21, or have health conditions that could interfere with study participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of varying nicotine content in both cigarettes and e-cigarettes on individuals who use both products. It aims to understand how reducing nicotine levels can help dual users decrease their tobacco consumption and dependence. Participants will be randomized to receive different nicotine levels to assess their smoking behavior and cravings. The study is motivated by the FDA's plans to limit nicotine in cigarettes, which could potentially lead to reduced tobacco-related harm.
Why it matters
Potential benefit: If successful, this approach could help dual users of e-cigarettes and cigarettes reduce their tobacco use and dependence, leading to better health outcomes.
How similar studies have gone: Previous randomized controlled trials have shown success with very low nicotine content cigarettes in reducing smoking behavior, indicating potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Regular use of tobacco * 21 year of age or older * Speak, comprehend and read English well enough to complete study procedures Exclusion Criteria: * Pregnant, trying to become pregnant, or nursing * Under the age of 21 * Health conditions that could undermine ability to complete the study
Where it's running
-
Brown University
Providence, Rhode Island, United States Recruiting -
University of Vermont
Burlington, Vermont, United States Recruiting
Study contacts
- Principal investigator: Elias Klemperer, PhD — University of Vermont
- Study coordinator: Emily Booth
- Email: emily.booth@med.uvm.edu
- Phone: 802-656-1641
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.