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01
Overview
Phase 2, randomised, double-blind trial in nicotine dependence comparing NIC002 Arm with Placebo Arm (2 arms). Primary endpoints: Smoking status at 12 weeks and Exhaled carbon monoxide at 12 weeks. Started Aug 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NIC002 Arm
Active vaccine group
Placebo Arm
Control group
03
Who it enrols
Healthy smokers aged 18-65, smoking 10+ cigarettes/day with high nicotine dependence (FTND >= 5) and motivated to quit.
04
Endpoints
Primary
Smoking status
Exhaled carbon monoxide
Secondary
Smoking status at various time intervals
Safety and tolerability
Immunogenicity (specific anti-nicotine antibodies in serum)
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