Switching to E-cigarettes in Smokers Not Interested in Quitting

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
University of Kansas Medical Center
Study ID
NCT05703672
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Smoking Reduction

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.
  • Electronic cigarette — OTHER
    Nicotine salt pod based e-cigarette in 5% nicotine

Study Details

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 Dates

Start date
Jul 17, 2023
Status verified
Dec 2025
Primary completion
Dec 7, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Swope Health CentralKansas CityMissouri64130
Tricia Snow
[email protected]
816-599-5311
University of Kansas Medical CenterKansas CityMissouri64130
Tricia Snow, MPH
[email protected]
816-398-8960

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By research site
Swope Health Central· Kansas City, MOUniversity of Kansas Medical Center· Kansas City, MO

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