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
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:[email protected]
QUESTIONS/COMMENTS?
Thank you very much and Shalom