Switching to E-cigarettes in Smokers Not Interested in Quitting

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Smoking Reduction

In brief

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.

Key facts

Study ID

NCT05703672

Run by

University of Kansas Medical Center

People needed

500

Starts

2023-07-17

Expected to finish

2027-02-28

Last updated by the study team

2025-12-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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 is running

• Swope Health Central — Kansas City, Missouri, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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