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

Smoking Cessation Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432575
• Other study ID #: DRI6938
• Secondary ID: EUDRACT: 2006-00
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2007
• Last updated: April 14, 2009
• Start date: January 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• surinabant (SR147778)
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
Norway	Sanofi-Aventis Administrative Office	Lysaker
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma
Switzerland	Sanofi-Aventis Administrative Office	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Norway,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit		during the last four weeks of treatment	No
Secondary	Change from baseline in total body weight		8 weeks	No
Secondary	Total score of the Questionnaire of Smoking Urges		8 weeks	No
Secondary	Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)		14 weeks	Yes