Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine. The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
810
oral administration
oral administration
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milan, Italy
Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit
Time frame: during the last four weeks of treatment
Change from baseline in total body weight
Time frame: 8 weeks
Total score of the Questionnaire of Smoking Urges
Time frame: 8 weeks
Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)
Time frame: 14 weeks
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Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sanofi-Aventis Administrative Office
Geneva, Switzerland