the healing potential of mdma dr. ingrid pacey principal investigator mdma / ptsd research in canada...
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The Healing Potential of MDMA
Dr. Ingrid PaceyPrincipal Investigator
MDMA / PTSD Research in CanadaMultidisciplinary Association for Psychedelic Studies
May, 2014
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Why MDMA for PTSD?
Obstacles to treating PTSDFear
Hyper vigilance
Defensiveness / numbing
Lack of trust
Integration
Present and connected during the experience
Greer & Tolbert, J Psychoactive Drugs, 1986; 18(4):319-327; Greer & Tolbert, J Psychoactive Drugs, 1998; 30(4):371-379
MDMA Diminishes the Obstacles:
Decrease fear and defensiveness
Increase trust and empathy
Provide Affirming experiences
More realistic perspective about present circumstances/safety
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Amygdala and Prefrontal Cortex
PTSDMediated by emotional memory- increased amygdala activity
Decreased activity in prefrontal cortex- Thought Center
MDMAReduces fear & suppresses activity in amygdala
Increased blood flow and Activity in prefrontal cortex
Rauch SL et al. Biol Psychiatry. 2006;60(4):376-382, Gamma et al. 20003
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Neurotransmitters and Hormones
Monoamine release and reuptake inhibition Serotonin (5-HT)Norepinephrine (NE)Dopamine (DA)Greatest effects are on serotonin release
Elevates plasma concentrations of a number of hormones:OxytocinVasopressinCortisolProlactinDehydroepiandrosterone (DHEA)Adrenocorticotropic hormone (ACTH)
Wolff, et al. J. Psychopharm, 2006, 20(3):400-410; Dumont, et al. Soc Neurosci, 2009, 4(4): 359-366; Hysek, et al. Psychopharmacology (Berl), 2012, 222(2): 293-302; Bedi et al., Biol Psychiatry, 2010, 68(12): 1134-1140; Guastella, et al. Biol Psychiatry, 2010, 67: 692-694; Parrott, et al. Neuropsychobiology, 2009, 60(3-4): 148-158;
Cami, et al. Ann N Y Acad Sci, 2000, 914:225-237; Harris, et al. Psycopharmacol (Berl) 2002, 162(4): 396-405; Farre, et al. Psycopharmacol (Berl) 2004, 173(3-4): 364-375
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A Window of Tolerance
•Increased sensation•Emotional reactivity•Intrusive imagery•Disorganized cognitive processing
•Relative absence of sensation•Numbing of emotions•Disabled cognitive processing•Reduced physical movement
Ogden P et al. Psychiatr Clin North Am. 2006;29(1):263-279, xi-xii
Hyperarousal Zone
Hypoarousal Zone
Window of Tolerance / Optimal Arousal Zone
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“Before, I knewthe path wasthrough a battlefield,but I could not getthrough it.During MDMA therapy,I knew I couldwalk through it andI wasn’t afraid.MDMA gave methe abilitynot to fear.”Donna, a patient inthe US pilot study
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Positive Safety Profile
•Phase 1 & Phase 2 clinical trials > 800 people
•No unexpected unexpected drug-related serious adverse events in medical research settings using pure MDMA
•Adverse Events are generally mild to moderate and self limited
•Neurocognitive function –RBANS and PASATNo change pre and post MDMA or placebo
•Changes in Vital signs during sessions similar between MDMA and Placebo Group
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More common with MDMA:
Decreased concentration
Jaw Clenching
Dizziness
Dry mouth
Feeling cold
Impaired Balance
Anxiety
Common Side Effects
More common with inactive placebo:Anxiety
Drowsiness
Insomnia
Jerome L. (+/-)-3,4-methylenedioxymethamphetamine (MDMA, “Ecstasy”) Investigator’s Brochure. December 2007. www.maps.org/research/mdma/protocol/ib_mdma_new08.pdf. Accessed Aug. 16, 2012.8
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Toxicity in Recreational Users
Rare cases of Serious acute toxicity in recreational usersNeurotoxicity in animals at high, repeated IV doses, not relevant to doses used in human studiesPET scans- no change in estimated serotonin transporter binding sites 4 weeks after a clinically relevant dose of MDMAModerate abuse potential
Jerome L. (+/-)-3,4-methylenedioxymethamphetamine (MDMA, “Ecstasy”) Investigator’s Brochure. December 2007. www.maps.org/research/mdma/protocol/ib_mdma_new08.pdf. Accessed Aug. 16, 2012; Mithoefer MC et al. J Psychopharm. 2011;25(4):439-452; Mithoefer MC et al. J Psychopharm. 2012; In press. 9
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Benefits of MDMA
•Enhances psychotherapy, not taken as ongoing medication
•Desirable effects on brain activity, neurochemistry and hormones
•Positive Risk/Benefit Ratio
•Attenuates the fear response and decreases defensiveness without blocking access to memories while encouraging a deep and genuine experience of emotion (Metzner et al. 1988).
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Study Design
phone session for 7 days following each experimental session
Screening/Baseline
90 min Prep Sessions
1
2
3
MDMA orPlacebo
1
2
3
90- MinIntegrativeSessions
ExpSession
1
2
3ExpSession
ExpSession
1
2
3
MDMA
Outcome
12 mn
Follow
Up
Outcome
Stage 2
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Objectives and Measures
Clinician Administered PTSD Scale (CAPS)
Beck Depression Inventory (BDI-II)Global Assessment of Functioning (GAF)Posttraumatic Growth Inventory (PTGI)Pittsburgh Sleep Quality Index (PSQI)NEO Personality Inventory (NEO)VAS for pain and tinnitus
Monitoring for Safety•Side effects, adverse events•Concomitant medication•Suicidality•Vital Signs
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Therapeutic Approach
Characterized as non-directive and supportive of the emerging experience
Treatment Manual is available at www.maps.org 13
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Private Practice Setting
ER Doctor Psychiatrist,IFS, Holotropic BreathworkAssistant Clinical ProfessorMedical University of South Carolina
Psychiatric NurseHolotropic BreathworkHakomi
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PTSD Severity-Mean CAPS Score by Group after MDMA or Placebo
Baseline Post Session 2 Placebo/Active Post Session 3
Mithoefer MC et al. J Psychopharm. 2011;25(4):439-45215
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“After the MDMA took effect, my soul sparked back to life. I felt connected to a vibrant life force, and I awakened to a childlike curiosity and inner power. I learned that I shape my reality and control my destiny with how I perceive and how I act. Now I feel that my true strength is facing my weaknesses and fears, and moving on from there. I am not perfect, but I have learned a lot about myself. If something gets the fear going, I can see it as something I can learn from.”
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Visit us online at:www.maps.org
www.mdmaptsd.org
www.facebook.com/mapsmdma
www.youtube.com/mapsmdma
http://www.bluelight.ru/MAPS-Forums
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Publications of this Work
Mithoefer, MC, Wagner, MT, Mithoefer, AT, Jerome, L, Doblin, R. The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. J Psychopharmacol, 2011. 25(4): p. 439-52.
Mithoefer, MC, Wagner, MT, Mithoefer, AT, Jerome, L, Martin, SF, Yazar-Klosinski, BB, Michel, Y, Brewerton, T, Doblin, R. Durability of Improvement in Posttraumatic Stress Disorder Symptoms and Absence of Harmful Effects or Drug Dependency after {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy: A Prospective Long-term Follow-up Study. J Psychopharmacol, Epub online 2012, Nov 20. 18