Yale University
New Haven, Connecticut, 06520, United States
NCT Number: NCT06027840
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06520, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Week 12
7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide
Time frame: Week 12
7-day point prevalence e-cigarette abstinence at Week 12, biochemically verified by urine cotinine
Time frame: Baseline up to week 12
Number of cigarettes smoked per day assessed by self-report
Time frame: Baseline up to week 12
Percent days of e-cigarette usage assessed by self-report
Time frame: Baseline up to week 12
Primary urinary biomarkers of tobacco-related harm exposure will be assessed including NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), a tobacco carcinogen linked to lung cancer risk.
Yale University
Other
A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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