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Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (No participants enrolled.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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE November 25, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Cigarettes smoked over 24 hours [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2013)
Body mass index [ Time Frame: 4 weeks ]
We will measure if body mass increases as a consequence of smoking cessation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
Official Title  ICMJE Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • Other: electronic cigarette
    V2 Cigs with 24 mg nicotine cartridges
  • Drug: nicotine inhaler
    nicotine inhaler with 10 mg nicotine cartridges
    Other Name: Nicotrol inhaler
Study Arms  ICMJE
  • Experimental: electronic cigarette
    electronic cigarette 24mg cartridges; 1-2 cartridges daily
    Intervention: Other: electronic cigarette
  • Active Comparator: nicotine inhaler
    nicotine inhaler 10mg cartridge; max 16 cartridges daily
    Intervention: Drug: nicotine inhaler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 17, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
40
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004171
Other Study ID Numbers  ICMJE #6863 P50DA009236-20
P50DA009236-20 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Barney Vaughan, MD New York State Psychiatric Institute/Columbia University
PRS Account New York State Psychiatric Institute
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP