Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
40

Inclusion Criteria

Capable of giving informed consent and complying with study procedures
Seeking treatment for smoking cessation
Meet DSM-IV criteria for nicotine dependence
...
Capable of giving informed consent and complying with study procedures
Seeking treatment for smoking cessation
Meet DSM-IV criteria for nicotine dependence
18-60 year old
Smoking at least 15 cigarettes per day

Exclusion Criteria

Use of cannabis or alcohol on more than 20 days in the past 30 days
Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
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
...
Use of cannabis or alcohol on more than 20 days in the past 30 days
Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
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
Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
Risk for suicide
Current DSM-IV diagnosis of substance dependence, other than nicotine
Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy

Summary

Conditions
Tobacco Use Disorder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

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.

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.

Inclusion Criteria

Capable of giving informed consent and complying with study procedures
Seeking treatment for smoking cessation
Meet DSM-IV criteria for nicotine dependence
...
Capable of giving informed consent and complying with study procedures
Seeking treatment for smoking cessation
Meet DSM-IV criteria for nicotine dependence
18-60 year old
Smoking at least 15 cigarettes per day

Exclusion Criteria

Use of cannabis or alcohol on more than 20 days in the past 30 days
Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
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
...
Use of cannabis or alcohol on more than 20 days in the past 30 days
Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
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
Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
Risk for suicide
Current DSM-IV diagnosis of substance dependence, other than nicotine
Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy

Tracking Information

NCT #
NCT02004171
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
  • Principal Investigator: Barney Vaughan, MD New York State Psychiatric Institute/Columbia University
  • Barney Vaughan, MD New York State Psychiatric Institute/Columbia University