Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2004

Interventions

  • Drug: rimonabant

Clinical Trial Outcome Measures

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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Trial Transparency Team, sanofi-aventis
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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