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

Completed · Phase 3

Conditions studied: Smoking Cessation

In brief

The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker. 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.

Key facts

Study ID

NCT00464256

Run by

Sanofi

People needed

533

Starts

2004-04-01

Expected to finish

2004-11-01

Last updated by the study team

2010-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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