Search > Dual Use Of Cigarettes And E-cigarettes
My employer runs this trial

Nicotine Replacement Therapy for Smoking and Vaping

RP
TP
Overseen ByTalia Program Assistant
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults who currently smoke cigarettes and use e-cigarettes (dual users) and are motivated to quit both. Participants must be willing to try quitting with support, but specific age or health exclusions aren't listed here.

Inclusion Criteria

I am 18 years old or older.
Access to text, internet, and email
Report nicotine-containing e-cigarette use 5 or more times per day, more than 5 days per week, for over 6 months
See 3 more

Exclusion Criteria

Endorse symptoms of Cannabis Use Disorder based on the CUDIT assessment
Report use of other tobacco or nicotine products more than once per week in the past 3 months
Have medical contraindications for nicotine replacement therapy use such as recent myocardial infarction, arrhythmias, angina, vascular disease, or conditions contraindicating phenylalanine consumption like PKU
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotine Replacement Therapy (NRT) - Nicotine Lozenge
  • Nicotine Replacement Therapy (NRT) - Nicotine Patch
  • Text- and web-based support

Trial Overview

The study compares three approaches: no medication (behavioral support only), standard-dose nicotine replacement therapy (nicotine patch plus lozenges), and higher-dose combination NRT. All groups get online/text-based behavioral support over 12 weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Standard dose NRTExperimental Treatment3 Interventions
Group II: High dose NRTExperimental Treatment3 Interventions
Group III: Behavioral SupportActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.