Recruiting
Phase 3

E-cigarettes

Sponsor:

University of Kansas Medical Center

Code:

NCT05703672

Conditions

Smoking Reduction

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Varenicline Tartrate

Placebo

Electronic cigarette

Study Details

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.

Conditions

Smoking Reduction

Study ID

NCT05703672

Start date

Jul 17, 2023

Status verified date

Dec, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Varenicline and electronic cigarette

At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.

placebo comparator: Placebo and electronic cigarette

At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.

other: Open label electronic cigarette

All participants will receive an initial 6-week supply of the study electronic cigarette.

Interventions

Varenicline Tartrate

0.5 mg once daily for days 1-3, 0.5mg twice daily for days 4-7 and 1.0 mg twice daily from day 8 through week 12.

Placebo

One pill (white) once daily for days 1-3, one pill (white) twice daily for days 4-7 and one pill (blue) twice daily from day 8 through week 12.

Electronic cigarette

Nicotine salt pod based e-cigarette in 5% nicotine

Primary outcome measure

  • Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) . [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Tricia Snow, MPH

816-398-8960psnow@kumc.edu

Locations

Swope Health Central

Recruiting

Kansas City, Missouri, United States, 64130

Contacts

Tricia Snow

816-599-5311psnow@kumc.edu

University of Kansas Medical Center

Recruiting

Kansas City, Missouri, United States, 64130

Contacts

Tricia Snow, MPH

816-398-8960psnow@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-12-29.