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

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ClinicalTrials.gov Identifier: NCT00432575
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 7, 2007
First Posted Date  ICMJE February 8, 2007
Last Update Posted Date April 15, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2007)
Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxyde and cotinine) at every visit during the last four weeks of treatment
Change History Complete list of historical versions of study NCT00432575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2007)
  • Main secondary: body weight
  • Others: Questionnaire of Smoking Urges, Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: surinabant (SR147778)
    oral administration
  • Drug: placebo
    oral administration
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Active Comparator: 2
    surinabant 2,5 mg/day
    Intervention: Drug: surinabant (SR147778)
  • Active Comparator: 3
    surinabant 5 mg/day
    Intervention: Drug: surinabant (SR147778)
  • Active Comparator: 4
    surinabant 10 mg/day
    Intervention: Drug: surinabant (SR147778)
Publications * Tonstad S, Aubin HJ. Efficacy of a dose range of surinabant, a cannabinoid receptor blocker, for smoking cessation: a randomized controlled clinical trial. J Psychopharmacol. 2012 Jul;26(7):1003-9. doi: 10.1177/0269881111431623. Epub 2012 Jan 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2009)
810
Original Enrollment  ICMJE
 (submitted: February 7, 2007)
800
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   Belgium,   France,   Germany,   Italy,   Norway,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00432575
Other Study ID Numbers  ICMJE DRI6938
EUDRACT: 2006-005334-2L
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claire VILAIN, M.D. Sanofi
PRS Account Sanofi
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP