Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

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

PHASE2

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

Brief Summary

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Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.

The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration

2

surinabant 2,5 mg/day

Group Type ACTIVE_COMPARATOR

surinabant (SR147778)

Intervention Type DRUG

oral administration

3

surinabant 5 mg/day

Group Type ACTIVE_COMPARATOR

surinabant (SR147778)

Intervention Type DRUG

oral administration

4

surinabant 10 mg/day

Group Type ACTIVE_COMPARATOR

surinabant (SR147778)

Intervention Type DRUG

oral administration

Interventions

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surinabant (SR147778)

oral administration

Intervention Type DRUG

placebo

oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.

Exclusion Criteria

* Patients with a limited level of motivation.
* Other participant in a household enrolled in the study.
* Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product more than 3 days within the 3 months preceding the screening visit.
* Patients dependent to alcohol or illicit drugs.
* Patients with a diagnosis of Psychotic Disorder or currently presenting with a Depressive Episode.
* Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past 6 months prior to screening.
* Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No