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The Healing Potential of MDMA . Dr. Ingrid Pacey Principal Investigator MDMA / PTSD Research in Canada Multidisciplinary Association for Psychedelic Studies May, 2014. Why MDMA for PTSD?. MDMA Diminishes the Obstacles: Decrease fear and defensiveness Increase trust and empathy

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The Healing Potential of MDMA


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    1. The Healing Potential of MDMA Dr. Ingrid Pacey Principal Investigator MDMA / PTSD Research in Canada Multidisciplinary Association for Psychedelic Studies May, 2014

    2. Why MDMA for PTSD? • MDMA Diminishes the Obstacles: • Decrease fear and defensiveness • Increase trust and empathy • Provide Affirming experiences • More realistic perspective about present circumstances/safety • Obstacles to treating PTSD • Fear • 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 2

    3. Amygdala and Prefrontal Cortex PTSD Mediated by emotional memory- increased amygdala activity Decreased activity in prefrontal cortex- Thought Center MDMA Reduces 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. 2000 3

    4. 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: • Oxytocin • Vasopressin • Cortisol • Prolactin • Dehydroepiandrosterone (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 AcadSci, 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 4

    5. A Window of Tolerance Hyperarousal Zone Window of Tolerance / Optimal Arousal Zone Hypoarousal Zone • 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 5

    6. “Before, I knew the path was through a battlefield, but I could not get through it. During MDMA therapy, I knew I could walk through it and I wasn’t afraid. MDMA gave me the ability not to fear.” Donna, a patient in the US pilot study 6

    7. 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 PASAT • No change pre and post MDMA or placebo • Changes in Vital signs during sessions similar between MDMA and Placebo Group 7

    8. 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

    9. Toxicity in Recreational Users • Rare cases of Serious acute toxicity in recreational users • Neurotoxicity in animals at high, repeated IV doses, not relevant to doses used in human studies • PET scans- no change in estimated serotonin transporter binding sites 4 weeks after a clinically relevant dose of MDMA • Moderate 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

    10. 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). 10

    11. Study Design 90- Min Integrative Sessions 90 min Prep Sessions 12 mn F o l l o w U p O u t c o me O u t c o me 1 1 1 1 Screening/Baseline 2 2 2 2 Exp Session Exp Session Exp Session 3 3 3 3 MDMA MDMA or Placebo Stage 2 • phone session for 7 days following each experimental session 11

    12. 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 • . 12

    13. Therapeutic Approach Characterized as non-directive and supportive of the emerging experience Treatment Manual is available at www.maps.org 13

    14. Private Practice Setting ER Doctor Psychiatrist, IFS, Holotropic Breathwork Assistant Clinical Professor Medical University of South Carolina Psychiatric Nurse Holotropic Breathwork Hakomi 14

    15. PTSD Severity-Mean CAPS Score by Group after MDMA or Placebo Baseline Post Session 2 Placebo/Active Post Session 3 15 Mithoefer MC et al. J Psychopharm. 2011;25(4):439-452

    16. “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.” 16

    17. Visit us online at: www.maps.org www.mdmaptsd.org www.facebook.com/mapsmdma www.youtube.com/mapsmdma http://www.bluelight.ru/MAPS-Forums 17

    18. 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