Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

Not Applicable

Withdrawn

• Conditions: Tobacco Use Disorder
• Interventions: Drug: nicotine inhaler; Other: electronic cigarette

• Registration Number: NCT02004171
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-11-25
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-09
• Status Verified: 2014-11
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nicotine inhaler	nicotine inhaler	nicotine inhaler 10mg cartridge; max 16 cartridges daily
electronic cigarette	electronic cigarette	electronic cigarette 24mg cartridges; 1-2 cartridges daily

Primary Outcome Measures

Name	Time	Method
Cigarettes smoked over 24 hours	4 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse reaction to nicotine inhaler or electronic cigarette	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.
Symptoms of nicotine withdrawal	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	4 weeks	we will measure perceived benefits from smoking cessation including improved breathing, improved sense of taste and smell, and improved physical fitness.

Trial Locations

Locations (1)

Substance Treatment and Research Services (STARS); 🇺🇸 New York, New York, United States