Smoking Cessation Clinical Trial
Official title:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
Verified date | May 2012 |
Source | Nabi Biopharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Status | Completed |
Enrollment | 1000 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NicVAX Investigator | Baltimore | Maryland |
United States | NicVAX Investigator | Boise | Idaho |
United States | NicVAX Investigator | Boston | Massachusetts |
United States | NicVAX Investigator | College Park | Maryland |
United States | NicVAX Investigator | Denver | Colorado |
United States | NicVAX Investigator | Draper | Utah |
United States | NicVAX Investigator | Farmington | Connecticut |
United States | NicVAX Investigator | Lexington | Kentucky |
United States | NicVAX Investigator | Los Angeles | California |
United States | NicVAX Investigator | Madison | Wisconsin |
United States | NicVAX Investigator | Miami | Florida |
United States | NicVAX Investigator | Minneapolis | Minnesota |
United States | NicVAX Investigator | Newport Beach | California |
United States | NicVAX Investigator | Norfolk | Virginia |
United States | NicVAX Investigator | Omaha | Nebraska |
United States | NicVAX Investigator | Portland | Oregon |
United States | NicVAX Investigator | Raleigh | North Carolina |
United States | NicVAX Investigator | Rochester | New York |
United States | NicVAX Investigator | San Diego | California |
United States | NicVAX Investigator | Seattle | Washington |
United States | NicVAX Investigator | St. Petersburg | Florida |
United States | NicVAX Investigator | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Nabi Biopharmaceuticals | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate NicVAX as an aid to smoking cessation for long term abstinence. | one year | No | |
Secondary | Evaluate abstinence rates at multiple intervals | multiple time points | No | |
Secondary | Evaluate safety and immunogenicity | mulitple time points | Yes | |
Secondary | Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. | multiple time points | Yes |
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