Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

New York State Psychiatric Institute

Status: Withdrawn

Conditions: Tobacco Use Disorder

Treatments: Other: electronic cigarette; Drug: nicotine inhaler

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02004171

#6863 P50DA009236-20

P50DA009236-20 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

electronic cigarette

Experimental group

Description:

electronic cigarette 24mg cartridges; 1-2 cartridges daily

Treatment:

Other: electronic cigarette

nicotine inhaler

Active Comparator group

Description:

nicotine inhaler 10mg cartridge; max 16 cartridges daily

Treatment:

Drug: nicotine inhaler