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Recruiting NCT05703672

Switching to E-cigarettes in Smokers Not Interested in Quitting

Phase III Interventional Smoking Reduction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Varenicline Tartrate, Placebo, Electronic cigarette.
Who it may be relevant to
Registry conditions: Smoking Reduction. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users

Overview

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

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.

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

Primary outcome measures

  • Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) . [Time frame: Week 6]
Secondary outcome measures (1)
  • Carbon Monoxide (CO) verified 7-day point prevalence abstinence from cigarettes [Time frame: Week 12 post randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Swope Health Central — Kansas City
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT05703672 · STUDY00146887

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗