Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06027840

Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use

Led by Yale University · Updated on 2025-05-06

40

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both products. The study will also compare the effect of treatment on health-related biomarkers. All participants will receive varenicline, a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e., links to text-based support, self-change booklet). Varenicline helps to reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.

CONDITIONS

Official Title

Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be literate in English
  • Have smoked cigarettes and used e-cigarettes for at least the past 3 months
  • Smoke 5 or more cigarettes per day
  • Have used e-cigarettes for at least 14 days in the past month
  • Be interested in quitting both cigarettes and e-cigarettes within the next month and willing to set a quit date
Not Eligible

You will not qualify if you...

  • Pregnant women, children, prisoners, or institutionalized individuals
  • Participants unable to provide their own consent
  • Currently using any smoking cessation services or FDA-approved cessation medications
  • Female participants under 55 who are pregnant, breastfeeding, or unwilling to use effective birth control during the study
  • Use of other tobacco or nicotine products more than once per week in the last 30 days
  • Medical contraindications for varenicline such as severe kidney problems or unstable heart conditions
  • Current serious uncontrolled medical or psychiatric conditions requiring recent hospitalization or intensive outpatient treatment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

L

Lisa Fucito, PhD

CONTACT

M

Madilyn Augustine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use | DecenTrialz