An interventional study of Switching to E-Cigarette and Switching using Medication in Cigarette Smoking and Smoking Behaviors, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention
This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.
Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking.
These data are urgently needed for several reasons.
The reviews underscore the need for additional data on this topic, especially data comparing the products to pharmacotherapy. The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products (e-cigarettes) have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 225 is above the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
This arm includes participants randomly assigned to the Meds Group. Participants will choose between 1) combo NRT and 2) varenicline. The NRT will consist of transdermal NRT and nicotine lozenge. Participants will receive study product for 11 weeks.
Behavioral: Switching using Medication
This arm includes participants randomly assigned to the E-Cigarette Group. Participants will choose between two different brands of e-cigarettes and choose up to two different flavors. Participants will receive study product for 11 weeks.
Behavioral: Switching to E-Cigarette
Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date
Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback
Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide \< 6 ppm
Time frame: 11 Weeks
Greater than 50% reduction in cigarette smoking
Average reduction in the number of cigarettes smoked per day on 7-day timeline followback at Week 11 of at least 50% or greater compared to average baseline number of cigarettes smoked per day on 7 day timeline followback
Time frame: 11 Weeks
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