Status:
COMPLETED
Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)
Lead Sponsor:
Sanofi
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.
Exclusion
- Patients with a limited level of motivation.
- Other participant in a household enrolled in the study.
- Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product more than 3 days within the 3 months preceding the screening visit.
- Patients dependent to alcohol or illicit drugs.
- Patients with a diagnosis of Psychotic Disorder or currently presenting with a Depressive Episode.
- Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past 6 months prior to screening.
- Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT00432575
Start Date
January 1 2007
End Date
April 1 2008
Last Update
April 15 2009
Active Locations (8)
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1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Paris, France
3
Sanofi-Aventis Administrative Office
Berlin, Germany
4
Sanofi-Aventis Administrative Office
Milan, Italy