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

Phase 3 Completed 755 enrolled Sanofi

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2004-09
Primary completion: 2005-07
Completion: 2005-07

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rimonabant	Small molecule	20 mg	—

Indications

No indication recorded.