Switching to E-cigarettes in Smokers Not Interested in Quitting

ConditionSmoking Reduction

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age21+

SponsorUniversity of Kansas Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥ 21 years of age

Smoke >5 cigarettes per day

Smoked cigarettes for > 6 months

Verified smoker (CO > 5 ppm)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
Nicotine salt pod based e-cigarette in 5% nicotine

Treatment groups

500 Participants

are divided into 3 treatment groups

Group A: Varenicline and electronic cigaretteExperimental treatment 2 interventions

Group B: Placebo and electronic cigarettePlacebo comparator 2 interventions

Group C: Open label electronic cigaretteOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Week 6

Secondary outcomes

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

CO verified 7-day point prevalence abstinence from cigarettes at week 12 post randomization.

Time frame

Week 12 post randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kansas Medical Center

Lead sponsor

Source ClinicalTrials.gov

Apply now