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Mordechai Mashiah, MD, MHA. Deputy Director, Abarbanel Mental Hospital, Israel Promising Results in an Open Pilot Study MEDICAL CANNABIS AS TREATMENT FOR CHRONIC COMBAT PTSD Patients Out of Time Conference, Tucson, Arizona April 28, 2012
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MEDICAL CANNABIS AS TREATMENT FOR CHRONIC COMBAT PTSD€¦ · treatment program for parcipants suffering from PTSD has been under my charge in Israel. Currently due to Ministry of

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Page 1: MEDICAL CANNABIS AS TREATMENT FOR CHRONIC COMBAT PTSD€¦ · treatment program for parcipants suffering from PTSD has been under my charge in Israel. Currently due to Ministry of

MordechaiMashiah,MD,MHA.

DeputyDirector,AbarbanelMentalHospital,Israel

PromisingResultsinanOpenPilotStudy

MEDICALCANNABISASTREATMENTFORCHRONIC

COMBATPTSD

Patients Out of Time Conference,

Tucson, Arizona April 28, 2012

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INTRODUCTION IamtheDeputyDirectoroftheAbarbanelMentalHospital‐thelargestmentalhospitalinIsraelwith300+beds

 Forthepast3yearsthelicensingofthecannabistreatmentprogramforparMcipantssufferingfromPTSDhasbeenundermychargeinIsrael.

 CurrentlyduetoMinistryofDefenserestricMonsastocombat‐relatedPTSDoutofthe~8,000totalpaMentstreatedwithcannabisinIsraelthereareonly~200parMcipantsreceivingcannabistotreatchronicPTSD.

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DSM‐IV‐TRCRITERIAFORPTSD

Adisorderbasedonseveralcriterion

experiencedoverMme.

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 ThepersonhasbeenexposedtoatraumaMceventinwhichbothofthefollowinghavebeenpresent:

 Thepersonhasexperienced,witnessed,orbeenconfrontedwithaneventoreventsthatinvolveactualorthreateneddeathorseriousinjury,orathreattothephysicalintegrityofoneselforothers.

 Theperson'sresponseinvolvedintensefear,helplessness,orhorror.

A B C DE F

STRESSORCRITERION

A

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Thetrauma0ceventispersistentlyre‐experiencedinatleastoneofthefollowingways:1. RecurrentandintrusivedistressingrecollecMonsoftheevent,includingimages,thoughts,orpercepMons.2. Recurrentdistressingdreamsoftheevent.3. AcMngorfeelingasifthetraumaMceventwererecurring(includesasenseofrelivingtheexperience,illusions,hallucinaMons,anddissociaMveflashbackepisodes,includingthosethatoccuruponawakeningorwhenintoxicated).4. IntensepsychologicaldistressatexposuretointernalorexternalcuesthatsymbolizeorresembleanaspectofthetraumaMcevent.5. PhysiologicreacMvityuponexposuretointernalorexternalcuesthatsymbolizeorresembleanaspectofthetraumaMcevent

A B C DE F

INTRUSIVERECOLLECTIONCRITERION

B

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Persistentavoidanceofs0muliassociatedwiththetraumaandnumbingofgeneralresponsiveness(notpresentbeforethetrauma),asindicatedbyatleastthreeofthefollowing:1.  Effortstoavoidthoughts,feelings,orconversaMons

associatedwiththetrauma2.  EffortstoavoidacMviMes,places,orpeoplethatarouse

recollecMonsofthetrauma3.  Inabilitytorecallanimportantaspectofthetrauma4.  MarkedlydiminishedinterestorparMcipaMoninsignificant

acMviMes5.  Feelingofdetachmentorestrangementfromothers6.  Restrictedrangeofaffect(e.g.,unabletohaveloving

feelings)7.  Senseofforeshortenedfuture(e.g.,doesnotexpectto

haveacareer,marriage,children,oranormallifespan)

A B C DE F

CRITERION

C AVOIDANT/NUMBING

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Persistentsymptomsofincreasingarousal(notpresentbeforethetrauma),indicatedbyatleasttwoofthefollowing:1.  Difficultyfallingorstayingasleep2.  Irritabilityoroutburstsofanger3.  DifficultyconcentraMng4.  Hyper‐vigilance5.  Exaggeratedstartleresponse

A B C DE F

HYPERAROUSALCRITERION

D

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DuraMonofthedisturbance(symptomsinB,C,andD)ismorethanonemonth.

A B C DE F

DURATIONCRITERION

E

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Thedisturbancecausesclinicallysignificantdistressorimpairmentinsocial,occupaMonal,orotherimportantareasoffuncMoning.

A B C DE F

FUNCTIONALSIGNIFICANCECRITERION

F

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Acute:IfduraMonofsymptomsislessthanthreemonthsChronic:IfduraMonofsymptomsisthreemonthsormoreWithorWithoutdelayonset:Onsetofsymptomsatleastsixmonthsaherthestressor

DSM‐IVPTSDSpecify if:

Specify if:

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CLINICALADMINISTEREDPTSD(CAPS)

CAPS

• ThisisaniniMalself‐reportsymptomchecklist.• ItcoversallkindsofPTSDsymptoms.• Theself‐reportchecklistisusedbythecliniciantoguidetheinterviewfortheassessment.• CAPShasbecomethestandardofPTSDassessmentbecauseitgivesclinicianstheabilitytofocusonthemosteffecMveareasoftreatment.

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BaselinePTSDinthisstudy: Studysymptomseverity(CAPSscore)washigh:(97.7+/‐13.3)

 Israelisastressfulanddenseplacewithmanywarsandterroristajacks.AsaresultwehavemanyvicMmsofPTSD.IbelievethebaselineforPTSDisprobablyhigheringeneralinIsrael.

 ThesewerealreadywellestablishedchronicandseverePTSDsufferers.

PTSDINISRAEL

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TheefficacyofcurrentlyavailablemedicaMonsinthetreatmentofchroniccombatpost‐traumaMcstressdisorder(PTSD)isvariable,withsomepaMentsnotachievingremission.• ThisopenpilotstudywasdesignedtotesttheeffectsofsmokedcannabisonsymptomsofchroniccombatPTSD.

OUROBJECTIVE:REMISSION

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 EnrollmentProfileAsmallnumber(N=29)ofIsraelimale,combatveterans,diagnosedwithPTSD

•  bytheIsraelDefenseForcePTSDUnit•  bytheMinistryofDefenseRehabilitaMonDivision.

 Assessments• AssessmentsincludedPTSDsymptomseverityusingthe(CAPS)interview

•  aself‐assessmentofqualityoflife(QOL)(partofCAPS)•  aclinician‐assessmentofclinicalimprovement.

METHODOLOGY(2008)

or

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 Howourpar0cipantsusedCannabis?Smokedmedicalindicacannabisofroughly23%THCandless

than1%CBDwasdispensedtothesubjects:•  atanamountofnomorethan100gramspermonth(basedontheirlicense’slimitandsetatahighleveltothwartunduedistress)

•  Cannabiswasaddedtosubjects'standingtreatment•  SubjectswereinstructedtosmokethecannabisdailyatMmes,frequenciesandamountsoftheirownchoosingunMltheyfeltrelaxed.

 Followup:whatwelearned?CAPSassessmentswereconductedbythePaMent’sPsychiatrist:

•  Atonset,andthenatanaverageof:•  4.3months,(+/‐3.3months),•  7.6months(+/‐2.7months),•  11.3months(+/‐2.9months).

METHODOLOGY(2008)

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MEDICALCANNABIS

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 29startedthestudy. 26completedthesecondCAPS 25completedthethirdCAPS 10completedthefinalCAPS

PRELIMINARYRESULTS

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Whathappenedfollowingcannabisuse? Onaverage,symptomreducMonintheremaining

26subjectswasseeninthesecondCAPSassessment:

PRELIMINARYRESULTS

CAPSAssessment AverageDura0onsincelastCAPSin

Months

AverageCAPSGlobal

SeverityScore*

Baseline ‐ 97.7±13.3

2 4.3±3.3 60.3±20.1

3 7.6±2.7 57.0±20.6

4 11.3±2.9 53.7±18.3

* CAPS Global Severity score of 50 is diagnostic cut-off for moderate PTSD

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 UseofmedicalcannabiswasassociatedwithareducMoninPTSDsymptomsinthisopen‐labelpilotstudy.

 Largerstudiesusingrandomized,double‐blindmethodologyareneededtodemonstrateacausalrelaMonship.

 Resultsshowthataher:4.3,7.6and11.3months,paMentssMllhadmoderatetoseverePTSD.

CONCLUSIONS

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 AddiMonalareasofstudyinclude: IdenMfyingtheacMveingredientsin

cannabisthathelpwithPTSD Establishingappropriatedoseand

duraMonoftreatment Determininghowcannabisreducesthe

needforothermedicaMons Clarifyingrisksofabuseandotherlegal

aspectsofmedicalcannabisuse.

FUTURERESEARCH

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WHATWEAREDOINGTODAYIbelievecannabiscanbeaneffec0vepartofaholis0ccaretreatmentinourclinics Wehavebegunplanninganewdouble‐blindrandomizedcontrolledtrialbasedontherequirementsputforthbyourMinistryofRehabilitaMon(partofourMinistryofDefense)mandaMng:clinicaltrialstoestablishcausalitybetweencannabisastreatmentandPTSD. WehavebegunplanningaretrospecMvestudytoassessthereducMonofmedicaMoncostanduse.

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ContactInforma0on:MordechaiMashiah,MD,MHA.DeputyDirectorAbarbanelMentalHealthCenterBatYamIsraelTelephone(fromtheUSA):972.50.626.56.38Email:[email protected]

QUESTIONS/COMMENTS?

Thank you very much and Shalom