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 Smoking Cessation (STRATUS US)

Smoking Cessation Clinical Trial

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 Smoking Cessation (STRATUS US, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358228
• Other study ID #: EFC4964
• Secondary ID: SR141716
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2006
• Last updated: December 9, 2010
• Start date: September 2002
• Est. completion date: August 2003

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 study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary study objectives were:

• To evaluate the effects of rimonabant on craving and weight;

• To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period

• To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers);

• To observe the percentage of abstinent patients during a 40-week follow-up post treatment period;

• To evaluate quality of life (QOL) and pharmacoeconomics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 787
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smokers smoking at least 10 cigarettes/day (on average) in the 2 months preceding screening visit;

• Motivated to quit smoking (Motivation Scale Score above or equal to 6 on a 10-point scale).

Exclusion Criteria:

• Smoked or consumed more than 3 times within the 3 months immediately preceding the screening visit: non tobacco cigarettes or related products or any form of tobacco product other than cigarettes;

• Current and regular consumption of marijuana (hashish).

• Met current criteria on the MINI International Neuropsychiatric Interview (MINI) for any of the following psychiatric disorders/states: major depressive episode, dysthymia, suicidality, manic episode or hypomanic episode, panic disorder, agoraphobia, social phobia (social anxiety disorder), obsessive compulsive disorder, posttraumatic stress disorder, alcohol dependence or abuse, substance dependence or abuse (excluding nicotine or caffeine), anorexia nervosa, bulimia nervosa, or generalized anxiety disorder;

• Met lifetime criteria on the MINI for manic episode or hypomanic episode, or psychotic disorders;

• Carried a diagnosis of, or suspicion of any cognitive disorder (eg, delirium, dementia, amnestic disorder) or any other psychiatric or developmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) that may interfere with his/her ability to understand or complete study related procedures;

• Had a history of severe depression, ie, those who have required hospitalization, or patients with 2 or more recurrent episodes of depression, or a history of multiple suicide attempts;

• Had used, within 3 months before the screening visit:

• Nicotine replacement of any type for more than 3 days at the maximum prescribed dose, or

• Behavioral and/or motivational counseling, therapy, support group, or other procedure intended to assist smoking cessation on more than 3 days, or

• Bupropion (amphebutamone), or

• Systemic long acting corticosteroids, or

• Any therapy intended to treat or alleviate depressive symptoms (pharmacologic, somatic, or psychological) for more than 1 week.

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	Malvern	Pennsylvania

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 tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.
Secondary	Analysis of mean change from baseline to last evaluation of the total score of QSU.
Secondary	Brief scale evaluating craving for tobacco cigarettes and relative change in body weight from baseline to last evaluation in patients with BMI lower than 30 kg/m2 at baseline achieving prolonged abstinence.