Switching to E-cigarettes in Smokers Not Interested in Quitting

NCT05703672 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY00146887
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) .

  Reduction in toxicant exposure as measured by NNAL excretion from baseline to week 6.

  Week 6

Secondary Outcomes (1)

• Carbon Monoxide (CO) verified 7-day point prevalence abstinence from cigarettes

  Week 12 post randomization

Study Arms (3)

Varenicline and electronic cigarette

EXPERIMENTAL

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.

Drug: Varenicline Tartrate; Other: Electronic cigarette

Placebo and electronic cigarette

PLACEBO COMPARATOR

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.

Drug: Placebo; Other: Electronic cigarette

Open label electronic cigarette

OTHER

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

Other: Electronic cigarette

Interventions

Placebo 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.

Placebo and electronic cigarette

Electronic cigarette OTHER

Nicotine salt pod based e-cigarette in 5% nicotine

Open label electronic cigarette; Placebo and electronic cigarette; Varenicline and electronic cigarette

Varenicline Tartrate 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.

Varenicline and electronic cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (2)

Swope Health Central

Kansas City, Missouri, 64130, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Missouri, 64130, United States

RECRUITING

MeSH Terms

Conditions

Smoking Reduction

Interventions

Varenicline; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nicole Nollen, PhD

  University of Kanas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia Snow, MPH

CONTACT

816-398-8960; psnow@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)