Comparing methods to quit smoking and vaping
A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects
This study is testing if quitting both smoking and vaping at the same time works better than quitting smoking first, using a medication and support to help participants.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06027840 on ClinicalTrials.gov |
What this trial studies
This research aims to determine whether quitting both cigarettes and e-cigarettes at the same time is more effective than quitting cigarettes first and then e-cigarettes. Participants will receive varenicline, a medication that helps reduce cravings, along with counseling and cessation resources. The study will last for 12 weeks and will involve assessments of smoking and vaping behaviors, medication use, and health-related biomarkers. Inclusion and exclusion criteria will be verified through an online screening followed by a tele-video or phone call.
Who should consider this trial
Good fit: Ideal candidates are English literate adults who have been smoking cigarettes and using e-cigarettes for at least three months and are motivated to quit both within the next month.
Not a fit: Patients who are currently using other smoking cessation services or medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective strategy for individuals looking to quit both smoking and vaping.
How similar studies have performed: While there is ongoing research in smoking cessation, this specific approach comparing concurrent versus sequential cessation methods is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Fucito, PhD — Yale University
- Study coordinator: Lisa Fucito, PhD
- Email: lisa.fucito@yale.edu
- Phone: 203-200-1470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.