Smoking, Smoking Cessation, Tobacco Cessation
Conditions
Keywords
smoking cessation, NicVAX, smoking vaccine, smoking abstinence, smoking, tobacco cessation
Brief summary
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Interventions
BIOLOGICALNicVAX vaccine
NicVAX vaccine given 6 times over 6 months
BIOLOGICALPlacebo vaccine
Placebo vaccine given 6 times over 6 months
Sponsors
National Institute on Drug Abuse (NIDA)
Nabi Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking. * Smokers who are in good general health.
Exclusion criteria
* Prior exposure to NicVAX or any other nicotine vaccine. * Use of systemic steroids. * Cancer or cancer treatment in last 5 years. * HIV infection. * History of drug or alcohol abuse or dependence within 12 months. * Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease. * Inability to fulfill all visits for approximately 52 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate NicVAX as an aid to smoking cessation for long term abstinence. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate abstinence rates at multiple intervals | multiple time points |
| Evaluate safety and immunogenicity | mulitple time points |
| Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. | multiple time points |
Countries
United States
Outcome results
None listed