Clinical trial NCT02004171: Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
Official title: Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: electronic cigarette
nicotine inhaler
smoking cessation
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cigarettes smoked over 24 hours
timeFrame: 4 weeks
Secondary outcomes:
measure: Symptoms of nicotine withdrawal
timeFrame: 4 weeks
measure: Benefits from smoking cessation
timeFrame: 4 weeks
measure: Adverse reaction to nicotine inhaler or electronic cigarette
timeFrame: 4 weeks
Other outcomes:
measure: Body mass index
timeFrame: 4 weeks
Locations:
city: New York
country: United States
facility: Substance Treatment and Research Services (STARS)
state: New York
Study officials:
affiliation: New York State Psychiatric Institute/Columbia University
name: Barney Vaughan, MD
role: PRINCIPAL_INVESTIGATOR
References: