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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: surinabant (SR147778)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* oral administration<br>|
| Active Comparator: 2<br>surinabant 2,5 mg/day | Drug: surinabant (SR147778)<br>* oral administration<br>|
| Active Comparator: 3<br>surinabant 5 mg/day | Drug: surinabant (SR147778)<br>* oral administration<br>|
| Active Comparator: 4<br>surinabant 10 mg/day | Drug: surinabant (SR147778)<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco use cessation, cigarette smokers