Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

Sanofi789 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

789

Conditions

Smoking Cessation

Interventions

rimonabantDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Sanofi-Aventis Administrative Office

Hørsholm, Denmark

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Barcelona, Spain

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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