MedTrace Logo

Switching to E-cigarettes in Smokers Not Interested in Quitting

NCT05703672 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-12-29

No results posted yet for this study

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

Interventions

DRUG

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.

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.

OTHER

Electronic cigarette

Nicotine salt pod based e-cigarette in 5% nicotine

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Nicole Nollen, PhD · University of Kanas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2026-12-07
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05703672 on ClinicalTrials.gov