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)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00358228
First received: July 28, 2006
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.

Condition Intervention Phase
Smoking Cessation
Drug: Rimonabant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Smoking Cessation (STRATUS US, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Analysis of mean change from baseline to last evaluation of the total score of QSU.
  • 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.

Enrollment: 787
Study Start Date: September 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358228

Locations
United States, Pennsylvania
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Lowell C. DALE, MD Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00358228     History of Changes
Other Study ID Numbers: EFC4964, SR141716
Study First Received: July 28, 2006
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Smoking cessation
Abstinence

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

ClinicalTrials.gov processed this record on October 29, 2014