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

NCT06027840 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20000357132P50CA196530-06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cigarette Smoking; E-Cigarette Use; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Cigarette Abstinence at Week 12- Carbon Monoxide

  7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide

  Week 12

Secondary Outcomes (4)

• E-Cigarette Abstinence at Week 12- Cotinine

  Week 12

• Number of cigarettes smoked per day

  Baseline up to week 12

• Percent days of e-cigarette usage

  Baseline up to week 12

• Biomarkers of tobacco-related harm exposure

  Baseline up to week 12

Study Arms (2)

QUIT-C (Concurrent)

EXPERIMENTAL

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.

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

QUIT-S (Sequential)

EXPERIMENTAL

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.

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

Interventions

Varenicline DRUG

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.

QUIT-C (Concurrent); QUIT-S (Sequential)

Counseling BEHAVIORAL

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.

QUIT-C (Concurrent); QUIT-S (Sequential)

Guided Self-Change Booklets BEHAVIORAL

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.

QUIT-C (Concurrent); QUIT-S (Sequential)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Vaping; Smoking Cessation

Interventions

Varenicline; Counseling

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lisa Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Fucito, PhD

CONTACT

203-200-1470; lisa.fucito@yale.edu

Madilyn Augustine

CONTACT

(203) 430-4714; madilyn.augustine@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)