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

Launched by YALE UNIVERSITY · Aug 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best way to help people quit using both cigarettes and e-cigarettes. Researchers want to find out if quitting both products at the same time (called "concurrent treatment") is more effective than quitting cigarettes first and then e-cigarettes later (called "sequential treatment"). All participants will receive a medication called varenicline, which helps reduce cravings and the pleasure people get from smoking, along with counseling and support resources to aid their quitting journey.

To be eligible for the study, participants should be between 18 and 74 years old, have been smoking cigarettes and using e-cigarettes for at least three months, and currently smoke at least five cigarettes a day. They must also be interested in quitting both products and be ready to set a quit date. However, individuals who are pregnant, breastfeeding, or using other tobacco products frequently may not be able to join. Throughout the trial, participants can expect support and guidance as they work towards quitting smoking and using e-cigarettes, which can ultimately improve their health.

Gender

ALL

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.