NCT06027840 Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use
| NCT ID | NCT06027840 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Cigarette Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-04-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Investigators will exclude anyone currently using any smoking cessation services and/or FDA pharmacotherapies. * 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. * Individuals using other tobacco or nicotine products besides cigarettes and e-cigarettes \> once per week in the last 30 days will be excluded. * 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.
Contact & Investigator
Lisa Fucito, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06027840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cigarette Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06027840 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06027840 currently recruiting?
Yes, NCT06027840 is actively recruiting participants. Contact the research team at lisa.fucito@yale.edu for enrollment information.
Where is the NCT06027840 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06027840 clinical trial?
NCT06027840 is sponsored by Yale University. The principal investigator is Lisa Fucito, PhD at Yale University. The trial plans to enroll 40 participants.