Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 40
Inclusion Criteria
- 18-60 year old
- Seeking treatment for smoking cessation
- Capable of giving informed consent and complying with study procedures
- ...
- 18-60 year old
- Seeking treatment for smoking cessation
- Capable of giving informed consent and complying with study procedures
- Smoking at least 15 cigarettes per day
- Meet DSM-IV criteria for nicotine dependence
Exclusion Criteria
- 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
- 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
- Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
- Risk for suicide
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
- Use of cannabis or alcohol on more than 20 days in the past 30 days
- Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
- 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
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
- 18-60 year old
- Seeking treatment for smoking cessation
- Capable of giving informed consent and complying with study procedures
- ...
- 18-60 year old
- Seeking treatment for smoking cessation
- Capable of giving informed consent and complying with study procedures
- Smoking at least 15 cigarettes per day
- Meet DSM-IV criteria for nicotine dependence
Exclusion Criteria
- 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
- 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
- Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
- Risk for suicide
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
- Use of cannabis or alcohol on more than 20 days in the past 30 days
- Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
- 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
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