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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432575
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : April 15, 2009
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: surinabant (SR147778) Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
oral administration

Active Comparator: 2
surinabant 2,5 mg/day
Drug: surinabant (SR147778)
oral administration

Active Comparator: 3
surinabant 5 mg/day
Drug: surinabant (SR147778)
oral administration

Active Comparator: 4
surinabant 10 mg/day
Drug: surinabant (SR147778)
oral administration

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432575

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Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
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Study Director: Claire VILAIN, M.D. Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00432575     History of Changes
Other Study ID Numbers: DRI6938
EUDRACT: 2006-005334-2L
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
tobacco use cessation
cigarette smokers

Additional relevant MeSH terms:
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Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs