A Phase 2 interventional study of Text- and web-based support and Nicotine Replacement Therapy (NRT, nicotine patch) in Dual Use of Cigarettes and E-cigarettes, sponsored by Medical University of South Carolina. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment
This randomized clinical trial evaluates the effectiveness of augmented-dose combination nicotine replacement therapy (NRT) versus standard-dose NRT and no-NRT control for cessation of dual combustible cigarette (CC) and electronic cigarette (EC) use. Adults who currently engage in dual use and are motivated to quit both products will be assigned to one of three 12-week interventions: (1) no pharmacotherapy (behavioral support only), (2) standard-dose NRT (21 mg nicotine patch + 4 mg lozenges, 5-20/day), or (3) augmented-dose NRT (21 mg + 14 mg patches + 4 mg lozenges, 5-30/day). All groups receive evidence-based behavioral support through the EX Program. Primary outcomes include biochemically confirmed dual abstinence and CC-only abstinence at 12 and 24 weeks. A subset of participants will provide blood and saliva samples to assess DNA damage biomarkers associated with tobacco use and cessation.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 321 is above the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive behavioral support only.
Behavioral: Text- and web-based support
Participants will receive a standard dose of nicotine replacement therapy (NRT).
Behavioral: Text- and web-based support · Drug: Nicotine Replacement Therapy (NRT, nicotine patch) · Drug: Nicotine replacement therapy lozenge
Participants will receive a higher dose of NRT than what is typically used.
Behavioral: Text- and web-based support · Drug: Nicotine Replacement Therapy (NRT, nicotine patch) · Drug: Nicotine replacement therapy lozenge
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
21mg patch
21mg + 14mg patch
4mg; 5-20/day
4mg; 5-30/day
Dual use abstinence
7-day point prevalence biochemically-confirmed abstinence from both e-cigarettes and cigarettes. E-cigarette abstinence is based on self-report and cotinine (if no longer using NRT) and cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation. Non-responders and missing data will be coded as not abstinent.
Time frame: Week 12, Week 24
Cigarette abstinence
7-day point prevalence biochemically-confirmed abstinence from cigarettes (and still using e-cigarettes). Cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation. Non-responders and missing data will be coded as not abstinent.
Time frame: Weeks 12, Week 24
Plan to share: Yes — Data will be uploaded to the National Institute of Mental Health (NIMH) Data Archive (NDA). All participant data uploaded to the repository will be de-identified. Shared data will include participants' self-reported survey responses, assessment scores, and results of biospecimen assays.
Supporting information: Study protocol
Access criteria: The NDA controls data access. Researchers need to request access, which is then decided upon by the NDA Data Access Committee. Standard NDA data access permits one-year access that is renewable.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get 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 →