e-Cigarettes Versus NRT Gum for Smoking Cessation

Study Overview
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Brief Summary
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This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.

Official Title
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e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation

Conditions
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Nicotine Addiction, Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine polacrilex
* Other: STAM 1100mAh CE4 eGo Clearomizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokes at least five cigarettes per day No current or previous regular use of e-cigarettes Ready to quit smoking Exclusion Criteria: Use of smokeless or pipe tobacco Smoke more than 40 cigarettes per day Pregnant or breastfeeding Unable to chew gum due to dental or jaw problems Myocardial infarction (heart attack) within the previous 12 months Hypersensitivity to propylene glycol or nicotine gum

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-Cigarette<br>STAM 1100mAh CE4 eGo Clearomizer e-Cigarette | Other: STAM 1100mAh CE4 eGo Clearomizer<br> <br> * Other names: electronic nicotine delivery device;|
| Active Comparator: Nicotine polacrilex<br>Nicotine Replacement gum | Drug: Nicotine polacrilex<br>* 2 mg and 4 mg gum will be used according to the FDA approved product labelling<br>* Other names: Nicotine Gum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Abstinence | No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Prevalence Abstinence | No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Nicotine Addiction, e-Cigarette, electronic nicotine delivery device, electronic cigarette, nicotine replacement therapy