Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use
Key facts
- Who runs it
- Yale University
- Where
- New Haven, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 1
- People taking part
- 19 people enrolled
- Started
- 1 Apr 2024
- Ended
- 30 Nov 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Varenicline
- Counseling
- Guided Self-Change Booklets
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- English literate
- Report cigarette smoking, and e-cigarette use for at least the past 3 months
- Smoke 5 or more cigarettes per day
- Report e-cigarette use for at least 14 days in the past month
- Interested in quitting both products in the next month and willing to set a quit date
Who cannot take part
- Investigators will exclude anyone currently using any smoking cessation services and/or FDA pharmacotherapies
- Investigators will exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment and unstable cardiac history)
- Medical Conditions: Investigators will not enroll anyone with a current, serious uncontrolled medical/psychiatric condition (e.g., a condition that required a hospitalization or intensive outpatient treatment in the past year) based on review by Study Physician that would increase risk of severe adverse events and/or interfere with study participation
- Verification of Non-Pregnancy: Females ages <55 will be given a commercially available pregnancy test to verify non-pregnancy. A female of child-bearing age that is currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms with spermicide) for the duration of the study will not be enrolled
- Vulnerable Populations: Investigators will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
- Investigators also will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted
- Individuals using other tobacco or nicotine products besides cigarettes and e-cigarettes > once per week in the last 30 days will be excluded
Where in United States
- Yale UniversityNew Haven, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- QUIT-C (Concurrent)Treatment being tested
Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation.
Treatment: Varenicline, Counseling, and Guided Self-Change Booklets
- QUIT-S (Sequential)Treatment being tested
Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation.
Treatment: Varenicline, Counseling, and Guided Self-Change Booklets
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects
- Record updated
- 5 November 2026