The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,000
NicVAX vaccine given 6 times over 6 months
Placebo vaccine given 6 times over 6 months
NicVAX Investigator
Encino, California, United States
Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation).
Time frame: One year
Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).
Time frame: One year
Evaluate safety based on adverse events.
Time frame: One year
Evaluate immunology based on serum antibody concentration.
Time frame: One year
Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report).
Time frame: One year
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NicVAX Investigator
Los Alamitos, California, United States
NicVAX Investigator
Denver, Colorado, United States
NicVAX Investigator
New Haven, Connecticut, United States
NicVAX Investigator
Brooksville, Florida, United States
NicVAX Investigator
Orlando, Florida, United States
NicVAX Investigator
Pembroke Pines, Florida, United States
NicVAX Investigator
Tampa, Florida, United States
NicVAX Investigator
Indianapolis, Indiana, United States
NicVAX Investigator
Wichita, Kansas, United States
...and 15 more locations