CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes

Conditions
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Smoking Cessation, Electronic Cigarette Use, Cigarette Smoking

Intervention / Treatment
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* Drug: Regular Nicotine patch and lozenge dose
* Drug: Augmented Nicotine patch and lozenge dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18yrs + Daily nicotine-containing e-cigarette user (25+ days per previous month) E-cigarette use 5+ times/day E-cigarette use > 1year Smoking >1 cigarette on 5-7 days per week Interest in quitting smoking and e-cigarette within the next month (>7 on 10-point scale) Willingness to use NRT Able to receive text messages/email Mailing address in South Carolina. Exclusion Criteria: Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated) Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications Those who vape non-nicotine substances Individuals unable to consent (e.g. significant cognitive deficit, non-English speaking).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>21mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day] | Drug: Regular Nicotine patch and lozenge dose<br>* 1mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day]<br>|
| Active Comparator: Arm B<br>21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & [up to 30 per day] | Drug: Augmented Nicotine patch and lozenge dose<br>* 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]<br>|
| Active Comparator: Arm C<br>2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day] | Drug: Augmented Nicotine patch and lozenge dose<br>* 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]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of dual use abstinence | Number of days participants self-report abstinence from both e-cigarettes and smoking. | Day 28, Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction | Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment. | Day 28, Day 56 | 
| Safety | Adverse events between groups will be evaluated. NRT side effects will be captured during daily diary assessments using the Systematic Assessment for Treatment Emergent Events (SAFTEE) | Day 28 | 
| Feasibility/Acceptability | Will be determined by the proportion of eligible subjects able to be contacted who subsequently enroll, the proportion of enrolled subjects who complete the Day 28 survey, and the proportion of enrolled subjects who complete ≥80% of their daily surveys during the treatment period. Participants will report satisfaction and helpfulness of the intervention at the end of treatment | Day 28 |