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Behavioral Intervention

Quitting Strategies + Varenicline for Smoking Cessation

Phase 1

Recruiting

Led By Lisa Fucito, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two ways to quit cigarettes and e-cigarettes: quitting both at the same time or quitting cigarettes first. Participants will get varenicline, counseling, and resources to help them quit.

Who is the study for?

This trial is for adults who have been smoking cigarettes and using e-cigarettes for at least 3 months, smoke 5+ cigarettes daily, use e-cigarettes on most days, and are ready to quit both within a month. It's not for pregnant or breastfeeding women, those unable to consent, people with severe kidney issues or unstable heart conditions, or users of other tobacco products more than once a week.

What is being tested?

The study tests if quitting cigarettes and e-cigarettes together (QUIT-C) works better than stopping them one after the other. Participants will all receive Varenicline—a medication that reduces cravings and enjoyment from tobacco—alongside counseling and self-help resources.

What are the potential side effects?

Varenicline may cause nausea, sleep problems (insomnia), constipation, gas, vomiting. It can also lead to mood swings or depression in some cases. Counseling and self-help booklets do not have physical side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cigarette Abstinence at Week 12- Carbon Monoxide

Secondary study objectives

Biomarkers of tobacco-related harm exposure

E-Cigarette Abstinence at Week 12- Cotinine

Number of cigarettes smoked per day

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: QUIT-S (Sequential)Experimental Treatment3 Interventions

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.

Group II: QUIT-C (Concurrent)Experimental Treatment3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Counseling

2017

Completed Phase 4

~1830

Varenicline

2011

Completed Phase 4

~4170