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

Smoking Cessation Clinical Trial

— STRATUS-META  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464256
• Other study ID #: EFC5794
• Secondary ID: SR141716
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2007
• Last updated: December 9, 2010
• Start date: April 2004
• Est. completion date: November 2004

Study information

• Verified date: December 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• rimonabant

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety data