Dual Use of Cigarettes and E-cigarettes
Conditions
Keywords
tobacco, smoking, cigarette, e-cigarette, dual use
Brief summary
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.
Interventions
BEHAVIORALText- and web-based support
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
21mg patch
4mg; 5-20/day
Sponsors
Medical University of South Carolina
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18+; * report nicotine-containing e-cigarette use 5+ times per day, \>5 days per week, for \> 6 months; * smoking \>1 cigarette per day, \>5 days per week, for \>6 months; * interest in quitting cigarettes and e-cigarettes within the next month (\>6 on 10-point scale); * willing to try nicotine replacement therapy; * access to text/internet/email.
Exclusion criteria
* report use of other tobacco or nicotine products (i.e., pouches, smokeless tobacco, hookah) \>1 time per week in the past 3 months; * have medical contraindications for nicotine replacement therapy use (patch and lozenge; e.g., recent myocardial infarction, arrhythmias, angina, vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated such as PKU); * report current use of smoking cessation medications (varenicline, bupropion, other nicotine replacement therapies); * endorse symptoms of Cannabis Use Disorder (using the CUDIT assessment); * unable to consent (e.g., cognitive deficit, non-English speaking); * live outside the US.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dual use abstinence | Week 12, Week 24 | 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. |
| Cigarette abstinence | Weeks 12, Week 24 | 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. |
Countries
United States
Contacts
CONTACTRachel Program Coordinator
CONTACTTalia Program Assistant
Outcome results
None listed