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    Summary
    EudraCT Number:2014-004978-42
    Sponsor's Protocol Code Number:ADDICTSTATINE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2014-004978-42
    A.3Full title of the trial
    Pilot randomized double blind, placebo controlled trial of the efficacy of simvastatin for smoking cessation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot randomized double blind, placebo controlled trial of the efficacy of simvastatin for smoking cessation
    A.3.2Name or abbreviated title of the trial where available
    ADDICTSTATINE
    A.4.1Sponsor's protocol code numberADDICTSTATINE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU DE POITIERS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFONDATION DE L AVENIR
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCORNWELL & MANN
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCHU DE POITIERS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE POITIERS
    B.5.2Functional name of contact pointABRIAT FANNY
    B.5.3 Address:
    B.5.3.1Street AddressDIRECTION DE LA RECHERCHE-2 RUE DE LA MILETRIE-CS90577
    B.5.3.2Town/ cityPOITIERS
    B.5.3.4CountryFrance
    B.5.4Telephone number0549443796
    B.5.5Fax number0549443058
    B.5.6E-mailfanny.abriat@chu-poitiers.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name simvastatin ZOCOR®40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMSD FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZOCOR
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Smoking cessation
    E.1.1.1Medical condition in easily understood language
    Cessation of Smoking
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10008374
    E.1.2Term Cessation of smoking
    E.1.2System Organ Class 100000004869
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy after a 3 months treatment by simvastatin versus placebo as an aid to quit smoking. The efficacy is estimated according the tobacco status: no reduction, reduction of 50% or more, abstinence.
    E.2.2Secondary objectives of the trial
    - To evaluate smoking abstinence rate. A participant is considered abstinent if he/she reports continuous abstinence from smoking confirmed by expired air carbon monoxide ≤8ppm and urinary cotinine concentration ≤10ng/mL during the last month of the 3 months treatment period.
    - To evaluate the decrease in cigarette consumption over the 3-month period of treatment with simvastatin versus placebo
    - To evaluate the duration of the abstinence from tobacco smoking over the 3-month period
    - To evaluate changes in tobacco smoking behavior (craving)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >=18 and <=70 years
    - Smoking more than 10 cigarettes per day for at least 1 year
    - Motivated to quit smoking
    - Without legal tutors or subordination
    - Affiliated to a health insurance system as required by the French law on biomedical research
    - Written informed consent for participation in the study
    E.4Principal exclusion criteria
    - Age < 18 or > 70 years
    - Presenting a contraindication to simvastatin use
    - With depression and/or psychosis and/or cognitive disorder and/or mental retardation or chronic use of medications for these disorders
    - Substance use disorder other than smoking
    - More than 3 months of abstinence from cigarette smoking in the previous year
    - Use of nicotine replacement therapy, bupropion, varenicline on last 3 months
    - Use of clonidine or nortriptyline on last 3 months
    - Undergoing on last 3 months’ cognitive-behavioral therapy for smoking cessation
    - Premenopausal women without contraception
    E.5 End points
    E.5.1Primary end point(s)
    Self-reported number of cigarettes smoked
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 3 months of simvastatin treatment
    E.5.2Secondary end point(s)
    - Self-reported continuous abstinence during the last 4 weeks of the 3 months of treatment with simvastatin versus placebo
    - Expired air carbon monoxide ≤ 8 ppm
    - Urinary cotinine concentration ≤ 10 ng/mL
    - Nicotine craving assessed by the FTCQ-12
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 3 months of simvastatin treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS+9 months for analysis +3 months for data verification =12 months after LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years24
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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