Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: placebo; Drug: surinabant (SR147778)

• Registration Number: NCT00432575
• Lead Sponsor: Sanofi

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-07
• Study First Submitted QC: 2007-02-07
• Study First Posted: 2007-02-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-14
• Last Update Posted: 2009-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 810

Inclusion Criteria

• Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	surinabant (SR147778)	surinabant 2,5 mg/day
3	surinabant (SR147778)	surinabant 5 mg/day
4	surinabant (SR147778)	surinabant 10 mg/day

Primary Outcome Measures

Name	Time	Method
Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit	during the last four weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in total body weight	8 weeks
Total score of the Questionnaire of Smoking Urges	8 weeks
Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)	14 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇭 Geneva, Switzerland