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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Recruitment Status : Withdrawn (No participants enrolled.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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: electronic cigarette Drug: nicotine inhaler Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Cigarettes smoked over 24 hours [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Body mass index [ Time Frame: 4 weeks ]
    We will measure if body mass increases as a consequence of smoking cessation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
United States, New York
Substance Treatment and Research Services (STARS)
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Barney Vaughan, MD New York State Psychiatric Institute/Columbia University

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02004171     History of Changes
Other Study ID Numbers: #6863 P50DA009236-20
P50DA009236-20 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: November 2014

Keywords provided by New York State Psychiatric Institute:
electronic cigarette
nicotine inhaler
smoking cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action