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

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

Outcome

Met primary endpoint

paper Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6-9 PMID 19149823 ↗

paper 39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71-2.37; P < 0.01 PMID 19149823 ↗

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.