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Switching to E-cigarettes in Smokers Not Interested in Quitting

NCT ID: NCT05703672

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Adult cigarette smokers (n=500) who are interested in switching to a nicotine salt-based electronic cigarette (EC) and are not established EC users will receive a 6-week supply of the EC and assistance with switching. After six weeks, those that are dual users (n=221) will receive an additional 12 weeks of the EC and be randomized in a 2:1 fashion to receive 12 weeks of varenicline (VAR) or placebo (PBO) and additional counseling to support a complete switch. Follow-up for all participants will continue through week 52. The primary outcome is change in the potent lung carcinogen, NNAL, between exclusive EC, dual cig-EC, and exclusive cig users at week 6.

Conditions

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Smoking Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Varenicline Tartrate

Intervention Type DRUG

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.

Electronic cigarette

Intervention Type OTHER

Nicotine salt pod based e-cigarette in 5% nicotine

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Intervention Type OTHER

Nicotine salt pod based e-cigarette in 5% nicotine

Open label electronic cigarette

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

Group Type OTHER

Electronic cigarette

Intervention Type OTHER

Nicotine salt pod based e-cigarette in 5% nicotine

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Electronic cigarette

Nicotine salt pod based e-cigarette in 5% nicotine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Nollen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kanas Medical Center

Locations

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Swope Health Central

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tricia Snow, MPH

Role: CONTACT

Phone: 816-398-8960

Email: [email protected]

Facility Contacts

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Tricia Snow

Role: primary

Tricia Snow, MPH

Role: primary

Other Identifiers

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STUDY00146887

Identifier Type: -

Identifier Source: org_study_id