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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00458718
• Collaborator: (none)
• Enrollment: 755
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 75.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: rimonabant (SR141716)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 755 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements []

Secondary Outcome Measures

1. 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 []

2. Safety data []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: ICD CSD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00458718
• Other Study ID Numbers: EFC4798
• First Posted: Apr 11, 2007
• Last Update Posted: Apr 20, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: abstinence; nicotine patch
• Additional relevant MeSH terms: Rimonabant

Study Results

No Results Posted as of Apr 20, 2009