Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation

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

4850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-09-30

Brief Summary

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The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking.

Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.

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Detailed Description

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Conditions

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Maintenance of Smoking Cessation

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 (SR141716)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No