A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT01102114
- Lead Sponsor
- Nabi Biopharmaceuticals
- Brief Summary
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
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 the 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation). One year
- Secondary Outcome Measures
Name Time Method Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation). One year Evaluate safety based on adverse events. One year Evaluate immunology based on serum antibody concentration. One year Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report). One year
Trial Locations
- Locations (1)
NicVAX Investigator
🇺🇸Charleston, West Virginia, United States
NicVAX Investigator🇺🇸Charleston, West Virginia, United States