Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

NCT ID: NCT02004171

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

electronic cigarette

electronic cigarette 24mg cartridges; 1-2 cartridges daily

Group Type: EXPERIMENTAL

electronic cigarette

Intervention Type: OTHER

V2 Cigs with 24 mg nicotine cartridges

nicotine inhaler

nicotine inhaler 10mg cartridge; max 16 cartridges daily

Group Type: ACTIVE_COMPARATOR

nicotine inhaler

Intervention Type: DRUG

nicotine inhaler with 10 mg nicotine cartridges

Interventions

electronic cigarette

V2 Cigs with 24 mg nicotine cartridges

Intervention Type: OTHER

nicotine inhaler

nicotine inhaler with 10 mg nicotine cartridges

Intervention Type: DRUG

Other Intervention Names

Nicotrol 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barney Vaughan, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute/Columbia University

Locations

Substance Treatment and Research Services (STARS)

New York, New York, United States

Countries

United States

Other Identifiers

P50DA009236-20

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#6863 P50DA009236-20

Identifier Type: -

Identifier Source: org_study_id