Switching to e-cigarettes for African American smokers
Official title: 4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users
Run by University of Kansas Medical Center · NCT05703672 · Data updated 2026-11-12
This study is testing whether switching to nicotine salt e-cigarettes can help African American smokers cut down on their cigarette use and reduce harm from smoking.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 2 sites (Kansas City, Missouri and 1 other locations) |
| Status | Recruiting |
| Started | July 17, 2023 |
| Main results expected | December 7, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05703672 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are African American smokers aged 21 and older who smoke more than 5 cigarettes per day and are interested in switching to e-cigarettes.
✕Probably not a fit
Patients who are actively seeking to quit smoking or have used other tobacco products recently 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 aims to evaluate the effectiveness of nicotine salt pod-based electronic cigarettes in promoting smoking reduction among African American smokers. It will compare the harm reduction and potential for abuse between exclusive e-cigarette users, dual users of cigarettes and e-cigarettes, and exclusive cigarette users. Participants will receive a 6-week supply of e-cigarettes and counseling, with dual users receiving additional treatment with varenicline or placebo for 12 weeks. The study will track changes in harmful substances and participant behavior over a year.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative to traditional smoking for African American smokers, potentially reducing health risks associated with smoking.
How similar studies have gone: Other studies have shown promise in using e-cigarettes for smoking cessation, but this specific approach focusing on African American smokers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 21 years of age * Smoke \>5 cigarettes per day * Smoked cigarettes for \> 6 months * Verified smoker (CO \> 5 ppm) * Functioning telephone * Interested in switching to EC * Willing to take varenicline and complete all study visits Exclusion Criteria: * Interested in quitting smoking * Use of smoking cessation pharmacotherapy in the month prior to enrollment * Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes) * EC use on \> 4 of the past 30 days * Uncontrolled hypertension: BP \> 180 (systolic) or \> 105 (diastolic) * Heart-related event in the past 30 days * Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation * Pregnant, contemplating getting pregnant, or breastfeeding * Plans to move from Kansas City metro area during the treatment and follow-up phase * Another household member enrolled in the study
Where it's running
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Swope Health Central
Kansas City, Missouri, United States Recruiting -
University of Kansas Medical Center
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Nicole Nollen, PhD — University of Kanas Medical Center
- Study coordinator: Tricia Snow, MPH
- Email: psnow@kumc.edu
- Phone: 816-398-8960
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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.