Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch

Completed · Phase 3

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT00458718

Run by

Sanofi

People needed

755

Starts

2004-09-01

Expected to finish

2005-07-01

Last updated by the study team

2009-04-20

Who can join

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

You may qualify if…

• Smokers smoking at least 15 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 — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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