Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

Tobacco Use Disorder Clinical Trial

Official title:

Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02004171
• Other study ID #: #6863 P50DA009236-20
• Secondary ID: P50DA009236-20
• Status: Withdrawn
• Phase: N/A
• First received: November 25, 2013
• Last updated: October 17, 2016
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2014
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• electronic cigarette
V2 Cigs with 24 mg nicotine cartridges

Drug:
• nicotine inhaler
nicotine inhaler with 10 mg nicotine cartridges

Locations

Country	Name	City	State
United States	Substance Treatment and Research Services (STARS)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	We will measure if body mass increases as a consequence of smoking cessation.	4 weeks	No
Primary	Cigarettes smoked over 24 hours		4 weeks	No
Secondary	Symptoms of nicotine withdrawal	We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite.	4 weeks	No
Secondary	Benefits from smoking cessation	we will measure perceived benefits from smoking cessation including improved breathing, improved sense of taste and smell, and improved physical fitness.	4 weeks	No
Secondary	Adverse reaction to nicotine inhaler or electronic cigarette	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.	4 weeks	Yes