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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00458718
First received: April 10, 2007
Last updated: April 17, 2009
Last verified: April 2009
History of Changes
  Purpose

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 Intervention Phase
Smoking Cessation
 Drug: rimonabant (SR141716)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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
  • Safety data

Enrollment: 755
Study Start Date: September 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458718

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00458718     History of Changes
Other Study ID Numbers: EFC4798
Study First Received: April 10, 2007
Last Updated: April 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
abstinence
nicotine patch

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013