Tobacco Use Disorder
Conditions
Keywords
electronic cigarette, nicotine inhaler, smoking cessation
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.
Interventions
OTHERelectronic cigarette
V2 Cigs with 24 mg nicotine cartridges
DRUGnicotine inhaler
nicotine inhaler with 10 mg nicotine cartridges
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cigarettes smoked over 24 hours | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | 4 weeks | We will measure if body mass increases as a consequence of smoking cessation. |
Countries
United States
Outcome results
None listed