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

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00432575

Enrollment

810

Registered

2007-02-08

Start date

2007-01-31

Completion date

2008-04-30

Last updated

2009-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

tobacco use cessation, cigarette smokers

Brief summary

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.

Interventions

DRUGsurinabant (SR147778)

oral administration

DRUGplacebo

oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit	during the last four weeks of treatment

Secondary

Measure	Time frame
Change from baseline in total body weight	8 weeks
Total score of the Questionnaire of Smoking Urges	8 weeks
Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)	14 weeks

Countries

Belgium, France, Germany, Italy, Norway, Spain, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026