Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Phase 2
Completed
- Conditions
- Smokers
- Interventions
- Biological: PlaceboBiological: NIC002
- Registration Number
- NCT00736047
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Healthy male and female smoking subjects age 18 to 65 years of age
- Subjects must be smoking 10 or more cigarettes per day during the past 12 months
- The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
- The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.
Exclusion Criteria
- Attempted to quit smoking in the three (3) months.
- Prior use of smoking cessation aid.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 NIC002 -
- Primary Outcome Measures
Name Time Method Smoking status 12 weeks Exhaled carbon monoxide 12 weeks
- Secondary Outcome Measures
Name Time Method Smoking status at various time intervals from target quit date to the end of the study 52 weeks Immunogenicity (specific anti-nicotine antibodies in serum) 52 weeks Safety and tolerability 52 weeks
Trial Locations
- Locations (2)
Novartis Investigator Site
🇩🇪Neuss, Germany
Novartis Investigative Site
🇩🇪Mainz, Germany