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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432575
First Posted: February 8, 2007
Last Update Posted: April 15, 2009
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.
Information provided by:
Sanofi
  Purpose

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 Intervention Phase
Smoking Cessation Drug: surinabant (SR147778) Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • Change from baseline in total body weight [ Time Frame: 8 weeks ]
  • Total score of the Questionnaire of Smoking Urges [ Time Frame: 8 weeks ]
  • Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events) [ Time Frame: 14 weeks ]

Enrollment: 810
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00432575


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00432575     History of Changes
Other Study ID Numbers: DRI6938
EUDRACT: 2006-005334-2L
First Submitted: February 7, 2007
First Posted: February 8, 2007
Last Update Posted: April 15, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
tobacco use cessation
cigarette smokers

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