MordechaiMashiah,MD,MHA.

DeputyDirector,AbarbanelMentalHospital,Israel

PromisingResultsinanOpenPilotStudy

MEDICALCANNABISASTREATMENTFORCHRONIC

COMBATPTSD

Patients Out of Time Conference,

Tucson, Arizona April 28, 2012

INTRODUCTION IamtheDeputyDirectoroftheAbarbanelMentalHospital‐thelargestmentalhospitalinIsraelwith300+beds

 Forthepast3yearsthelicensingofthecannabistreatmentprogramforparMcipantssufferingfromPTSDhasbeenundermychargeinIsrael.

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

DSM‐IV‐TRCRITERIAFORPTSD

Adisorderbasedonseveralcriterion

experiencedoverMme.

 ThepersonhasbeenexposedtoatraumaMceventinwhichbothofthefollowinghavebeenpresent:

 Thepersonhasexperienced,witnessed,orbeenconfrontedwithaneventoreventsthatinvolveactualorthreateneddeathorseriousinjury,orathreattothephysicalintegrityofoneselforothers.

 Theperson'sresponseinvolvedintensefear,helplessness,orhorror.

A B C DE F

STRESSORCRITERION

A

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

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

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

A B C DE F

HYPERAROUSALCRITERION

D

DuraMonofthedisturbance(symptomsinB,C,andD)ismorethanonemonth.

A B C DE F

DURATIONCRITERION

E

Thedisturbancecausesclinicallysignificantdistressorimpairmentinsocial,occupaMonal,orotherimportantareasoffuncMoning.

A B C DE F

FUNCTIONALSIGNIFICANCECRITERION

F

Acute:IfduraMonofsymptomsislessthanthreemonthsChronic:IfduraMonofsymptomsisthreemonthsormoreWithorWithoutdelayonset:Onsetofsymptomsatleastsixmonthsaherthestressor

DSM‐IVPTSDSpecify if:

Specify if:

CLINICALADMINISTEREDPTSD(CAPS)

CAPS

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

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

 Israelisastressfulanddenseplacewithmanywarsandterroristajacks.AsaresultwehavemanyvicMmsofPTSD.IbelievethebaselineforPTSDisprobablyhigheringeneralinIsrael.

 ThesewerealreadywellestablishedchronicandseverePTSDsufferers.

PTSDINISRAEL

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

OUROBJECTIVE:REMISSION

 EnrollmentProfileAsmallnumber(N=29)ofIsraelimale,combatveterans,diagnosedwithPTSD

•  bytheIsraelDefenseForcePTSDUnit•  bytheMinistryofDefenseRehabilitaMonDivision.

 Assessments• AssessmentsincludedPTSDsymptomseverityusingthe(CAPS)interview

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

METHODOLOGY(2008)

or

 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)

MEDICALCANNABIS

 29startedthestudy. 26completedthesecondCAPS 25completedthethirdCAPS 10completedthefinalCAPS

PRELIMINARYRESULTS

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

 UseofmedicalcannabiswasassociatedwithareducMoninPTSDsymptomsinthisopen‐labelpilotstudy.

 Largerstudiesusingrandomized,double‐blindmethodologyareneededtodemonstrateacausalrelaMonship.

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

CONCLUSIONS

 AddiMonalareasofstudyinclude: IdenMfyingtheacMveingredientsin

cannabisthathelpwithPTSD Establishingappropriatedoseand

duraMonoftreatment Determininghowcannabisreducesthe

needforothermedicaMons Clarifyingrisksofabuseandotherlegal

aspectsofmedicalcannabisuse.

FUTURERESEARCH

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

ContactInforma0on:MordechaiMashiah,MD,MHA.DeputyDirectorAbarbanelMentalHealthCenterBatYamIsraelTelephone(fromtheUSA):972.50.626.56.38Email:moM.mashiah@abr.health.gov.il

QUESTIONS/COMMENTS?

Thank you very much and Shalom