Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: electronic cigarette; Drug: nicotine inhaler

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Substance Treatment and Research Services (STARS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Nicotrol inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cigarettes smoked over 24 hours	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	We will measure if body mass increases as a consequence of smoking cessation.	4 weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Barney Vaughan, MD, New York State Psychiatric Institute/Columbia University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: smoking cessation; electronic cigarette; nicotine inhaler
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: #6863 P50DA009236-20; P50DA009236-20 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No