Reducing nicotine levels in cigarettes and e-cigarettes for dual users
A Randomized Controlled Trial of Reduced Nicotine Cigarettes and E-cigarettes Among Dual Users
PHASE2 · University of Vermont · NCT06614504
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Vermont (other) |
| Locations | 2 sites (Providence, Rhode Island and 1 other locations) |
| Trial ID | NCT06614504 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older who regularly use both cigarettes and e-cigarettes.
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.
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 performed: Previous randomized controlled trials have shown success with very low nicotine content cigarettes in reducing smoking behavior, indicating potential for this approach.
Eligibility criteria
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 this trial is running
Providence, Rhode Island and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tobacco Use Disorder, Cigarettes, E-cigarettes