An interventional study of Switching to a different medication and Continued use of the same medication in Cigarette Smoking, Smoking Behaviors and Treatment, 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 2026-08-12.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.
All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.
Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 544 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.
Counted across the registry records on this site, refreshed daily.
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 people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to medication will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again
Behavioral: Switching to a different medication
This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again
Behavioral: Continued use of the same medication
This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both). After two 4-week courses of pharmacotherapy, participants who are not responding to medication will be randomly assigned to a harm reduction group (e-cigarettes). Participants assigned to the harm reduction group will receive four weeks of e-cigarette product with instructions to switch completely
Behavioral: Switching to a harm reduction tobacco product
This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both sequentially). After two four-week courses of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again.
Behavioral: Continued use of the same medication
Participants will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4.
Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.
Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8
Non-responders after initial course of FDA-approved medication
7-day point prevalence abstinence at Week 8 among non-responders at Week 4
Time frame: 8 weeks
Dependence and duration of longest quit attempt
7-day point prevalence abstinence at Week 12 among non-responders at Week 8.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of South Carolina →