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

Yale University

Status and phase: Enrolling; Phase 1

Conditions: E-Cigarette Use; Cigarette Smoking; Smoking Cessation

Treatments: Behavioral: Counseling; Behavioral: Guided Self-Change Booklets; Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06027840

2P50CA196530-06 (U.S. NIH Grant/Contract)

2000035713

Details and patient eligibility

About

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.

Full 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 pregnancy test.

All participants will be asked to provide assessments (as described below) throughout the sampling process to assess cigarette smoking and e-cigarette use behavior, varenicline use, and use of cessation resources.

This is a 12 week, open-label study of varenicline.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

QUIT-C (Concurrent)

Experimental group

Description:

Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation.

Treatment:

Drug: Varenicline

Behavioral: Guided Self-Change Booklets

Behavioral: Counseling

QUIT-S (Sequential)

Experimental group

Description:

Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation.

Treatment:

Drug: Varenicline

Behavioral: Guided Self-Change Booklets

Behavioral: Counseling