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    Summary
    EudraCT Number:2014-002456-90
    Sponsor's Protocol Code Number:14060802
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-02
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2014-002456-90
    A.3Full title of the trial
    Integrated Exposure-Based Therapy for Co-occurring Posttraumatic Stress Disorder and Alcohol Dependence: Effects of the FAAH inhibitor PF-04457845 on Extinction. A Randomized Controlled Trial.
    Integrerad kognitiv beteendeterapi med exponering vid PTSD och samtidigt alkoholberoende , effekter av FAAH inhibitorn PF-04457845 på utsläckning av traumatiska minnen. En randomiserad kontrollerad studie.


    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can an integrated therapy for Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence (AD) be potentiated with the FAAH inhibitor PF-04457845 to improve the extinction of traumatic memories in women with co-morbid PTSD and AD?
    Kan en integrerad behandling för posttraumatiskt stressyndrom (PTSD) och alkoholberoende potentieras med FAAH hämmaren PF-04457845 för att förbättra utsläckningen av traumatiska minnen hos kvinnor med både PTSD och alkoholberoende?
    A.3.2Name or abbreviated title of the trial where available
    FAAH Inhibition in PTSD and Alcoholism
    FAAH-inhibition vid PTSD och alkoholberoende
    A.4.1Sponsor's protocol code number14060802
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN56834832
    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 SponsorStockholm Centre for Dependency Disorders, Department of Clinical Neuroscience, Karolinska Institutet
    B.1.3.4CountrySweden
    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 supportSRA, Systembolagets alkoholfond
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportStiftelsen (Foundation) Söderström-Königska sjukhemmet
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStockholm Centre for Dependency Disorders/Department of Clinical Neuroscience, Karolinska Institutet
    B.5.2Functional name of contact pointEWA Unit
    B.5.3 Address:
    B.5.3.1Street AddressTideliusgatan 26
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code118 69
    B.5.3.4CountrySweden
    B.5.4Telephone number0046812345 819
    B.5.5Fax number0046812349726
    B.5.6E-mailasa.magnusson@ki.se
    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.2.5The 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.3.2Product code PF04457845
    D.3.4Pharmaceutical form Tablet
    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 placeboTablet
    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
    Current Posttraumatic Stress Disorder (PTSD) and Current Alcohol Dependence
    Posttraumatiskt stressyndrom (PTSD), aktuellt och alkoholberoende, aktuellt
    E.1.1.1Medical condition in easily understood language
    Posttraumatic Stress Disorder (PTSD), an anxiety disorder triggered by severe trauma and Alcohol Dependence.
    Posttraumatiskt stressyndrom (PTSD) en ångestsjukdom som debuterar efter allvarligt trauma, samt alkoholberoende.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    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 ability of the Fatty Acid Amide Hydrolase (FAAH) inhibitor PF-04457845 to potentiate extinction of trauma memories in women with co-morbid PTSD and AD. Two hypotheses will be evaluated: That FAAH inhibition will reduce PTSD symptom severity; and that reduction in PTSD symptom severity will be associated with reduction in heavy drinking.
    Att undersöka om inhibering av fettsyraamidohydrolas (FAAH) kan förstärka utsläckningen av traumatiska minnen hos kvinnor med posttraumatiskt stressyndrom och samtidigt alkoholberoende. De hypoteser som skall testas är 1) huruvida en integrerad form av KBT med exponering och samtidig behandling av alkoholberoende (COPE), som försärks med FAAH-hämmaren PF-04457845 reducerar PTSD-symptomen jämfört med COPE plus placebo, samt 2) om reduktionen av PTSD-symptom är associerad med färre dagar med hög alkoholkonsumtion.
    E.2.2Secondary objectives of the trial
    Secondary and exploratory objective will be to evaluate whether
    1. PF-04457845 will decrease biomarkers of alcohol consumption
    2. PF-04457845 will decrease measures of stress
    3. Patient baseline characteristics, including genotype at loci within genes encoding elements of the EC system, interact with FAAH blockade to influence treatment outcomes.
    Studera om:
    1) PF-04457845 påverkar biomarkörer för alkoholkonsumtion
    2) PF-04457845 minskar stress
    3) Patientkarakteristika, inklusive genotyp vid loci inom gener som kodar för delar av EC-systemet, interagerar med FAAH-blockad och påverkar behandlingsresultatet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Female
    2) Age >18 years
    3) Diagnosed with current PTSD and current alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV), as determined by The Structured Clinical Interview for DSM IV Disorders and clinical examination by a psychiatrist.
    Inklusionskriteriet för studiedeltagande är 1) kvinnligt kön 2) 18 år eller äldre 3) PTSD samt alkoholberoende enligt DSM-IV.
    E.4Principal exclusion criteria
    1) Current DSM-IV substance dependence other than nicotine, as determined by SCID and clinical examination by a psychiatrist and negative urine screen for illicit drugs.
    2) Current DSM-IV psychotic, as determined by SCID, and clinical examination by a psychiatrist.
    3) Clinically significant suicidal or homicidal ideation on clinical assessment with the relevant section of The Mini International Neuropsychiatric Interview (MINI) and clinical examination by a psychiatrist.
    4) Any current medication or medical condition that in the judgment of the investigator could interfere with treatment.
    5) Pregnancy or nursing. To be eligible, women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug, and agree to use a method of contraception that is adequate in the judgment of the investigator for the duration of the study.
    6) Insufficient memory of the trauma (for prolonged exposure to be effective).
    7) Dissociative disorder which is more severe or affects the subject more than her PTSD.
    1) Aktuellt drogberoende enligt DSM-IV annat än nikotinberoende
    2) Aktuell obehandlad eller ej stabilt behandlad psykossjukdom
    3) Kliniskt signifikanta suicidtankar
    4) Pågående nödvändig medicinering, som bedöms kunna påverka studieresultatet eller interagera med det läkemedel som testas
    5) Somatisk sjukdom som bedöms kunna interagera med behandlingen/medicineringen
    6) Pågående graviditet eller amning. De kvinnor som rekryteras måste gå med på att använda preventivmedel under den period studien pågår
    7) Otillräckligt minne av traumat
    8) Dissociation som är svårare och påverkar patienter mer än PTSD-symptomen.
    E.5 End points
    E.5.1Primary end point(s)
    The CAPS-DX will be the primary outcome to determine PTSD symptom severity. CAPS-DX is a structured interview that corresponds to the DSM-IV criteria for PTSD, and a Swedish translation has been validated.

    Alcohol use ,alcohol consumption per week (grams per week) and heavy drinking days (HDD) derived from Timeline Follow back (TLFB).
    PTSD-symptomens svårighetsgrad mäts med CAPS-DX. CAPS-DX är en strukturerad intervju som motsvarar DSM-IV-kriterierna för PTSD, och en svensk översättning har validerats.
    Alkohol, alkoholkonsumtion per vecka (gram per vecka) och tunga dryckesdagar (HDD) som härrör från en så kallad alkonacka, Timeline Follow back (TLFB).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline, post session 12 and three months post treatment.
    Förändringar från baslinjemätningen jämfört med efter den avslutande 12:e COPE-sessionen samt tre månader efter avslutad behandling.
    E.5.2Secondary end point(s)
    Secondary and exploratory objective will be to evaluate whether
    1. PF-04457845 will decrease biomarkers of alcohol consumption (gamma glutamyltransferase (GGT), mean corpuscular volume (MCV), phosphatidylethanol (PEth), carbohydrate deficient transferrin (CDT), and ethylglucuronide (EtG))
    2. PF-04457845 will decrease measures of stress, indexed as cortisol in hair.
    3. Patient baseline characteristics, including genotype at loci within genes encoding elements of the EC system, interact with FAAH blockade to influence treatment outcomes.
    Studera om
    1. PF-04457845 påverkar biomarkörer för alkoholkonsumtion (gamma glutamyltransferas (GGT), medelcellvolym (MCV), fosfatidyletanol (PEth), kolhydratfattig transferrin (CDT), och ethylglucuronide (EtG))
    2. PF-04457845 minskar stress, mätt utifrån kortisolnivåer, indexerade som kortisol i håret.
    3) Patientkarakteristika, inklusive genotyp vid loci inom gener som kodar för delar av EC-systemet, interagerar med FAAH-blockad och påverkar behandlingsresultatet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline, post session 12 and three months post treatment.
    Förändringar från baslinjemätningen jämfört med efter den avslutande 12:e COPE sessionen samt tre månader efter avslutad behandling.
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 (120 of 120)
    Sista besök av sista deltagaren (120 av 120)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    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 No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    No other plans for treatment are planned after the subjects have ended their partcipation in the trial other than the expected normal treatment for alcohol use disorder.
    Inga andra planer för behandling efter studien avslutats än de sedvanliga vid alkoholberoende.
    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 Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-03-15
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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