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Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation (STRATUS-WW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459173
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : April 7, 2009
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Brief Summary:

The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking.

Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.

Condition or disease Intervention/treatment Phase
Maintenance of Smoking Cessation Drug: rimonabant (SR141716) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)
Study Start Date : November 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
  2. Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day

Secondary Outcome Measures :
  1. Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
  2. Safety data

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Smokers smoking at least 10 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459173

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Australia, New South Wales
Cove, New South Wales, Australia
Canada, Quebec
Laval, Quebec, Canada
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00459173     History of Changes
Other Study ID Numbers: EFC4796
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

Keywords provided by Sanofi:

Additional relevant MeSH terms:
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Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs