Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.
Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
1mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
21mg patch + 14mg patch qd + 4mg lozenge prn \[minimum of 5 \& up to 30 per day\] OR 2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
Medical University of South Carolina - Charleston
Charleston, South Carolina, United States
Days of Dual Use Abstinence
Number of days participants self-report abstinence from both e-cigarettes and smoking.
Time frame: Day 28, Day 56
Reduction
Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment.
Time frame: Day 28, Day 56
Safety (Adverse Events)
Adverse events and outcomes between groups will be evaluated.
Time frame: Day 28
Feasibility/Acceptability
Feasibility and acceptability were assessed by the proportion of eligible participants who enrolled, and among enrolled participants, the proportion who completed the Day 28 survey and the proportion who completed ≥80% of daily surveys during treatment.
Time frame: Day 28
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