Status:
RECRUITING
Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cigarette Smoking
E-Cigarette Use
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 trea...
Detailed Description
Inclusion/exclusion criteria will be determined via initial online screening and then confirmed with tele-video/phone call final screening. Non-pregnancy verification will be ascertained via remote pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06027840
Start Date
April 1 2024
End Date
December 1 2025
Last Update
May 6 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06520