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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cigarette Abstinence at Week 12- Carbon Monoxide

Secondary outcome measures

Biomarkers of tobacco-related harm exposure

E-Cigarette Abstinence at Week 12- Cotinine

Number of cigarettes smoked per day

+1 more

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

Varenicline

2011

Completed Phase 4

~4170

Counseling

2017

Completed Phase 4

~1970

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,521 Total Patients Enrolled

2 Trials studying Vaping

295 Patients Enrolled for Vaping

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,696 Total Patients Enrolled

5 Trials studying Vaping

3,373 Patients Enrolled for Vaping

Lisa Fucito, PhDPrincipal InvestigatorYale University

4 Previous Clinical Trials

361 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned QUIT-C (Concurrent) for use in clinical settings?

"Our team at Power applied a score of 1 to QUIT-C (Concurrent), as it is currently in the early stages of clinical trials with minimal evidence for safety and effectiveness."

Answered by AI

Are there any available slots in this clinical investigation for volunteers?

"The clinical trial is not currently accepting applicants; the initial posting was on September 1st 2023 and it has been edited for the last time on August 30th 2023. Notwithstanding, there are 184 other trials which are actively enrolling participants at this moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027840.

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