Back to resultsElectronic Cigarettes or Nicotine Inhaler for Smoking Cessation
Primary Purpose
Tobacco Use Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electronic cigarette
nicotine inhaler
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring electronic cigarette, nicotine inhaler, smoking cessation
Eligibility Criteria
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
Sites / Locations
- Substance Treatment and Research Services (STARS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
electronic cigarette
nicotine inhaler
Arm Description
electronic cigarette 24mg cartridges; 1-2 cartridges daily
nicotine inhaler 10mg cartridge; max 16 cartridges daily
Outcomes
Primary Outcome Measures
Cigarettes smoked over 24 hours
Secondary Outcome Measures
Symptoms of nicotine withdrawal
We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite.
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.
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.
Full Information
NCT ID
NCT02004171
First Posted
November 25, 2013
Last Updated
October 17, 2016
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02004171
Brief Title
Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
Official Title
Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled. Changed requirements for studying e-cigarettes.
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
electronic cigarette, nicotine inhaler, smoking cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electronic cigarette
Arm Type
Experimental
Arm Description
electronic cigarette 24mg cartridges; 1-2 cartridges daily
Arm Title
nicotine inhaler
Arm Type
Active Comparator
Arm Description
nicotine inhaler 10mg cartridge; max 16 cartridges daily
Intervention Type
Other
Intervention Name(s)
electronic cigarette
Intervention Description
V2 Cigs with 24 mg nicotine cartridges
Intervention Type
Drug
Intervention Name(s)
nicotine inhaler
Other Intervention Name(s)
Nicotrol inhaler
Intervention Description
nicotine inhaler with 10 mg nicotine cartridges
Primary Outcome Measure Information:
Title
Cigarettes smoked over 24 hours
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Symptoms of nicotine withdrawal
Description
We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite.
Time Frame
4 weeks
Title
Benefits from smoking cessation
Description
we will measure perceived benefits from smoking cessation including improved breathing, improved sense of taste and smell, and improved physical fitness.
Time Frame
4 weeks
Title
Adverse reaction to nicotine inhaler or electronic cigarette
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Body mass index
Description
We will measure if body mass increases as a consequence of smoking cessation.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barney Vaughan, MD
Organizational Affiliation
New York State Psychiatric Institute/Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Treatment and Research Services (STARS)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
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