Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00464165
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.
The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 789
Inclusion Criteria
- Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
- Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale
Exclusion Criteria
- Non tobacco cigarettes consumption
- Chronic use of marijuana
- Pregnancy, breastfeeding
- Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
- Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇬🇧Guildford, Surrey, United Kingdom