NCT05703672 Switching to E-cigarettes in Smokers Not Interested in Quitting
| NCT ID | NCT05703672 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Kansas Medical Center |
| Condition | Smoking Reduction |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-07-17 |
| Primary Completion | 2026-12-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2023-07-17 with a primary completion date of 2026-12-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in adult (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking.
Eligibility 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
Contact & Investigator
Nicole Nollen, PhD
PRINCIPAL INVESTIGATOR
University of Kanas Medical Center
Frequently Asked Questions
Who can join the NCT05703672 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Smoking Reduction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05703672 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT05703672 currently recruiting?
Yes, NCT05703672 is actively recruiting participants. Contact the research team at psnow@kumc.edu for enrollment information.
Where is the NCT05703672 trial being conducted?
This trial is being conducted at Kansas City, United States, Kansas City, United States.
Who is sponsoring the NCT05703672 clinical trial?
NCT05703672 is sponsored by University of Kansas Medical Center. The principal investigator is Nicole Nollen, PhD at University of Kanas Medical Center. The trial plans to enroll 500 participants.