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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

787 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Keywords

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Smoking cessation Abstinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Rimonabant

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Lowell C. DALE, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US

Locations

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Sanofi-Aventis Administrative Office

Malvern, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SR141716

Identifier Type: -

Identifier Source: secondary_id

EFC4964