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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: rimonabant (SR141716)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00458718

EFC4798

Details and patient eligibility

About

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.

Enrollment: 755 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind