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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2006-005334-2L |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Active Comparator | surinabant 2,5 mg/day |
|
| 3 | Active Comparator | surinabant 5 mg/day |
|
| 4 | Active Comparator | surinabant 10 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surinabant (SR147778) | Drug | oral administration |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
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| Name | Affiliation | Role |
|---|---|---|
| Claire VILAIN, M.D. | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Diegem | Belgium | ||||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22219220 | Derived | Tonstad S, Aubin HJ. Efficacy of a dose range of surinabant, a cannabinoid receptor blocker, for smoking cessation: a randomized controlled clinical trial. J Psychopharmacol. 2012 Jul;26(7):1003-9. doi: 10.1177/0269881111431623. Epub 2012 Jan 4. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C492668 | surinabant |
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| placebo |
| Drug |
oral administration |
|
| 14 weeks |
| Paris |
| France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Lysaker | Norway |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |