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The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit.
Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rimonabant (SR141716) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence | ||
| Safety data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19149823 | Derived | Rigotti NA, Gonzales D, Dale LC, Lawrence D, Chang Y; CIRRUS Study Group. A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain. Addiction. 2009 Feb;104(2):266-76. doi: 10.1111/j.1360-0443.2008.02454.x. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D010880 |
| Piperidines |