Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

Study Overview
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Brief Summary
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Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.

Detailed Description
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Cigarette smoking remains the leading cause of preventable death and disease worldwide. The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.

Official Title
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Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Other: electronic cigarette
* Drug: nicotine inhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 year old Meet DSM-IV criteria for nicotine dependence Seeking treatment for smoking cessation Smoking at least 15 cigarettes per day Capable of giving informed consent and complying with study procedures Exclusion Criteria: Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous Current DSM-IV diagnosis of substance dependence, other than nicotine Use of cannabis or alcohol on more than 20 days in the past 30 days Risk for suicide

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: electronic cigarette<br>electronic cigarette 24mg cartridges; 1-2 cartridges daily | Other: electronic cigarette<br>* V2 Cigs with 24 mg nicotine cartridges<br>|
| Active Comparator: nicotine inhaler<br>nicotine inhaler 10mg cartridge; max 16 cartridges daily | Drug: nicotine inhaler<br>* nicotine inhaler with 10 mg nicotine cartridges<br>* Other names: Nicotrol inhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes smoked over 24 hours |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of nicotine withdrawal | We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite. | 4 weeks | 
| Benefits from smoking cessation | we will measure perceived benefits from smoking cessation including improved breathing, improved sense of taste and smell, and improved physical fitness. | 4 weeks | 
| Adverse reaction to nicotine inhaler or electronic cigarette | we will assess for any possible side effect from the electronic cigarette or the nicotine inhaler, including irritation of the mouth and throat and cough. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic cigarette, nicotine inhaler, smoking cessation