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

PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Cigarette SmokingE-Cigarette UseSmoking Cessation
Interventions
DRUG

Varenicline

Varenicline prescription will follow the standard induction period: varenicline 0.5 mg once per day for Days 1-3, varenicline 0.5 mg twice per day for Days 4-7, then varenicline 1 mg twice per day (when varenicline reaches peak efficacy for tobacco cessation). Participants will remain on varenicline for 12 weeks total. Dose adjustments (e.g., reduction to 0.5 mg twice per day if 1 mg is not well tolerated) will be allowed at the discretion of the clinical pharmacist/APRN/physician.

BEHAVIORAL

Counseling

Tobacco Treatment Service clinicians will deliver weekly counseling sessions, monitor participants for adverse events, and record participants' weekly cigarette and e-cigarette use. At the first counseling session clinicians will review medication proper use instructions, and potential side effects and strategies to address them at the first counseling session. Study medication refills will be distributed at 4-week intervals. Sessions will focus on quit plan preparation, supportive and practical cessation counseling, resetting quit dates, and relapse prevention.

BEHAVIORAL

Guided Self-Change Booklets

The booklet includes information on how to reduce and quit both cigarettes and e-cigarettes on their own, how to prevent relapse, how to set a quit date, and how to enroll in text-based support resources.

Trial Locations (1)

06520

RECRUITING

Yale University, New Haven

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Yale University

OTHER