Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT02004171|
Recruitment Status : Withdrawn (No participants enrolled. Changed requirements for studying e-cigarettes.)
First Posted : December 9, 2013
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Other: electronic cigarette Drug: nicotine inhaler||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: electronic cigarette
electronic cigarette 24mg cartridges; 1-2 cartridges daily
Other: electronic cigarette
V2 Cigs with 24 mg nicotine cartridges
Active Comparator: nicotine inhaler
nicotine inhaler 10mg cartridge; max 16 cartridges daily
Drug: nicotine inhaler
nicotine inhaler with 10 mg nicotine cartridges
Other Name: Nicotrol inhaler
- Cigarettes smoked over 24 hours [ Time Frame: 4 weeks ]
- Symptoms of nicotine withdrawal [ Time Frame: 4 weeks ]We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite.
- Benefits from smoking cessation [ Time Frame: 4 weeks ]we will measure perceived benefits from smoking cessation including improved breathing, improved sense of taste and smell, and improved physical fitness.
- Adverse reaction to nicotine inhaler or electronic cigarette [ Time Frame: 4 weeks ]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.
- Body mass index [ Time Frame: 4 weeks ]We will measure if body mass increases as a consequence of smoking cessation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004171
|United States, New York|
|Substance Treatment and Research Services (STARS)|
|New York, New York, United States, 10032|
|Principal Investigator:||Barney Vaughan, MD||New York State Psychiatric Institute/Columbia University|