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

Smoking Cessation Clinical Trial

— CIRRUS  

Official title:

Single Country, Double-Blind, Randomized, 2-Arm, Parallel-Group Study, Evaluating Efficacy and Safety of Rimonabant 20 mg OD, With/Without Association of Nicotine Patch, as Aid to Smoking Cessation During 9-Week Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458718
• Other study ID #: EFC4798
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2007
• Last updated: April 17, 2009
• Start date: September 2004
• Est. completion date: July 2005

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 755
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• rimonabant (SR141716)

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements
Secondary	Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
Secondary	Safety data