Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation
The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker. The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period...
Brief Summary
Official Title: “Comparison of the Efficacy and Safety of a 20 mg/Day Oral Dose of Rimonabant Versus Placebo as an Aid to Smoking Cessation - a US, Randomized, Double-blind, 2 Arm, Placebo-controlled, Parallel-group, Fixed Dose, 12-week Study”
The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.
The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: November 2004
Intervention(s) in this Clinical Trial
- Drug: rimonabant
Outcome Measures for this Clinical Trial
Primary Measures
- Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
Secondary 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Clinical Sciences & Operations Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00464256
Study ID Number: EFC5794
ClinicalTrials.gov Identifier: NCT00464256
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00464256
