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Completed

NCT Number: NCT00432575

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

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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Key information

Conditions

Smoking Cessation Behavior Health Behavior Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

surinabant (SR147778)

Drug

oral administration

Placebo

Drug

oral administration

Primary outcomes

  1. Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit

    Time frame: during the last four weeks of treatment

Secondary outcomes

  1. Change from baseline in total body weight

    Time frame: 8 weeks

  2. Total score of the Questionnaire of Smoking Urges

    Time frame: 8 weeks

  3. Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 8, 2007
Registry last updated
Apr 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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