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The Healing Potential of MDMA

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Presentation on theme: "The Healing Potential of MDMA"— Presentation transcript:

1 The Healing Potential of MDMA
1 Dr. Ingrid Pacey Principal Investigator MDMA / PTSD Research in Canada Multidisciplinary Association for Psychedelic Studies May, 2014 My talk will focus on our work as a non-profit sponsor of clinical research. Currently our primary focus is on MDMA- assisted therapy for the treatment of PTSD. I will give an overview of our program, review some of our study results and briefly talk about a few case reports of tinnitus in our study subjects.

2 Why MDMA for PTSD? Obstacles to treating PTSD
Why do we think MDMA is the right choice for treating PTSD…. There are many reasons including the hormonal, neurological and subjective effects of PTSD that are specifically countered by the effects of MDMA. This combined with its ability to enhance therapy in very few sessions currently just 2-3 in our studies makes it a good candidate. Lets look first at the subjective effects. ********* PTSD- is a fear based disorder it is Characterized by Hyper-vigilance, defensiveness, numbing, Nightmares, intrusive memories, lack of trust and over activation of the amygdala M D M A d i r e c t l y e f f e c t s t h e s e s y m p t o m s b y R e d u c i n g f e a r a n d d e f e n s i v e n e s s A n d I n c r e a s i n g t h e r a p e u t i c b o n d i n g , t r u s t a n d e m p a t h y T h i s i s m e d i a t e d b y a r e l e a s e o f p r o - s o c i a l h o r m o n e l i k e o x y t o c i n w h i c h l e a d s t o I n c r e a s e d f e e l i n g s o f w e l l - b e i n g . T h r o u g h t h e s e a f f i r m i n g e x p e r i e n c e s s u b j e c t s g a i n n e w p e r s p e c t i v e o n t h e i r c u r r e n t s i t u a t i o n a n d p r e s e n t s t a t e o f s a f e t y Throughout the MDMA experience participants are able to be present and emotionally connected and this is very important for the integration of insights in follow up visits. The effects of MDMA in the sessions are Gentle but profound, the experiences are not necessarily easy– in fact we often hear “why is this called ecstasy” but because the flight or fight response is calmed subjects can stay with the experiences and continue to process them. 2 Why MDMA for PTSD? Obstacles to treating PTSD Fear Hyper vigilance Defensiveness / numbing Lack of trust Integration Present and connected during the experience MDMA Diminishes the Obstacles: Decrease fear and defensiveness Increase trust and empathy Provide Affirming experiences More realistic perspective about present circumstances/safety Greer & Tolbert, J Psychoactive Drugs, 1986; 18(4): ; Greer & Tolbert, J Psychoactive Drugs, 1998; 30(4): 2

3 Amygdala and Prefrontal Cortex
We can see these same ideas of fear and the suppression of fear in the model of the brain. ********* Fear memories are learned and stored in the amygdala, the traumatic event activates neurons, the signals are passed from one group of neurons to the next and on scans you can see this increased activity or hyper-activation in the amygdala. At the same time in the thought processing center of the brain, the the prefrontal cortex, you see decreased activity, equating to a Deficit in the extinction of fear conditioning *********** In contrast during MDMA administration you see a suppression of activity in the amygdala and an increase in blood flow to the prefrontal cortex where thoughts are processed leading to decrease in fear responses. The activity in the brain supports the idea that PTSD is a fear based disorder and MDMA can work to counteract the symptoms of PTSD and allow reprocessing of memories. We even see this in the way some of are subjects describe the experience. One participants said "It's like PTSD changed my brain and MDMA changed it back.” And here is another quote from a 12 month follow up: "It's helped me in so many ways.... "It feels like it's gradually rewiring my brain"....It feels like the MDMA sessions were the crack in the ice, because the trauma was so solid before that. 3 Amygdala and Prefrontal Cortex MDMA Reduces fear & suppresses activity in amygdala Increased blood flow and Activity in prefrontal cortex PTSD Mediated by emotional memory- increased amygdala activity Decreased activity in prefrontal cortex- Thought Center Rauch SL et al. Biol Psychiatry. 2006;60(4): , Gamma et al. 2000 3

4 Neurotransmitters and Hormones
4 W e c a n a g a i n s e e t h e s a m e i d e a s o f c h a n g e s i n f e a r a n d t r u s t r e f l e c t e d i n t h e e n d o c r i n e s y s t e m . P e o p l e w i t h P T S D h a v e d e c r e a s e d l e v e l s o f f e e l g o o d h o r m o n e s a n d i n c r e a s e d s t r e s s . M D M A h a s t h e a b i l i t y t o t u r n s o n a l l t h e f a u c e t s i n t h e b r a i n – i t i s a m o n o a m i n e r e l e a s e a n d r e u p t a k e i n h i b i t e r . t h e m a i n m o l e c u l e r e l e a s e i s s e r o t o n i n a l o n g w i t h n o r e p i n e p h r i n e a n d d o p a m i n e . T h i s r e l e a s e i s a N e u r o t r a n s m i t t e r c a s c a d e t h a t r e l e a s e s p r o - s o c i a l f e e l g o o d h o r m o n e s l i k e O x y t o c i n , V a s o p r e s s i n , c o r t i s o l a n d D H E A . T h i s i s a c t u a l l y s i m i l a r t o t h e h o r m o n e r e l e a s e d u r i n g h u g s , b o n d i n g w i t h a n e w i n f a n t , a n d p o s t o r g a s m . H e r e i s a q u o t e f r o m o n e o f o u r p a r t i c i p a n t s " A f t e r y o u ' v e r i d d e n a f e w o f t h o s e w a v e s o f f e a r t h e n i t g e t s e a s i e r a n d e a s i e r t o t r u s t t h e n e x t o n e . 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): ; Dumont, et al. Soc Neurosci, 2009, 4(4): ; Hysek, et al. Psychopharmacology (Berl), 2012, 222(2): ; Bedi et al., Biol Psychiatry, 2010, 68(12): ; Guastella, et al. Biol Psychiatry, 2010, 67: ; Parrott, et al. Neuropsychobiology, 2009, 60(3-4): ; Cami, et al. Ann N Y Acad Sci, 2000, 914: ; Harris, et al. Psycopharmacol (Berl) 2002, 162(4): ; Farre, et al. Psycopharmacol (Berl) 2004, 173(3-4): 4

5 Ogden P et al. Psychiatr Clin North Am. 2006;29(1):263-279, xi-xii
All of these effects create a window of tolerance in which processing of the trauma is possible. Typically people with PTSD are either hyper-aroused and in a overly sensitive reactionary state of they are hypo-aroused and numb. MDMA seems to balance this and creates and optimal arousal zone. In this state of optimal arousal people can find empathy for themselves, make connections and process the trauma instead of being caught in their conditioned fear response. It allows patients to recall truamtic memories but reconsolidate them without the intense emotions and physiologic arousal that can cause further trauma. 5 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 Hyperarousal Zone Window of Tolerance / Optimal Arousal Zone Hypoarousal Zone Ogden P et al. Psychiatr Clin North Am. 2006;29(1): , xi-xii 5

6 6 “Before, I knew the path was through a battlefield,
T h i s i s a q u o t e f r o m D o n n a , t h e f i r s t s u b j e c t i n o u r U S s t u d y . S h e h a d s u f f e r e d f o r 8 y e a r s w i t h P T S D B e f o r e , I k n e w t h e p a t h w a s t h r o u g h a b a t t l e f i e l d , b u t I c o u l d n o t g e t t h r o u g h i t . D u r i n g M D M A t h e r a p y , I k n e w I c o u l d w a l k t h r o u g h i t a n d I w a s n ’ t a f r a i d , M D M A g a v e m e t h e a b i l i t y n o t t o f e a r . ” “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
M D M A h a s G o o d s a f e t y r e c o r d i n s t u d i e s w i t h r e s e a r c h s u b j e c t s t h a t a r e c a r e f u l l y s c r e e n e d f o r c o n t r a i n d i c a t i o n s . T h e O n s e t e f f e c t s a r e a b o u t t o m i n u t e s a f t e r a d m i n i s t r a t i o n , w i t h p e a k e f f e c t s t o m i n u t e s p o s t - d r u g , d u r a t i o n o f e f f e c t s l a s t s f r o m t h r e e t o s i x h o u r s , w i t h m o s t e f f e c t s r e t u r n i n g t o b a s e l i n e s i x h o u r s a f t e r d r u g a d m i n i s t r a t i o n . I t p r o d u c e s a n e a s i l y c o n t r o l l e d i n t o x i c a t i o n c h a r a c t e r i z e d b y e u p h o r i a , i n c r e a s e d w e l l b e i n g , s o c i a b i l i t y , s e l f - c o n f i d e n c e , a n d e x t r o v e r s i o n , w i t h s o m e i n c r e a s e d a n x i e t y a n d m i n o r a l t e r a t i o n s i n p e r c e p t i o n . P r i o r t o s c h e d u l i n g a p p r o x i m a t e l y , d o s e s w e r e a d m i n i s t e r e d i n p s y c h o t h e r a p y s e s s i o n s i n N o r t h A m e r i c a . I n s t u d i e s p o s t s c h e d u l i n g o v e r p e o p l e h a v e r e c e i v e d M D M A i n p h a s e 1 a n d 2 s t u d i e s c o n d u c t e d b y v a r i o u s g r o u p s i n c l u d i n g M A P S . T h e r e h a v e b e e n N o u n e x p e c t e d s e r i o u s d r u g - r e l a t e d e v e n t s a n d e x p e c t e d A d v e r s e E v e n t s a r e g e n e r a l l y m i l d t o m o d e r a t e a n d s e l f l i m i t e d I n o u r f i r s t P h a s e 2 s t u d y w e m e a s u r e d n e u r o c o g n i t i v e f u n c t i o n w i t h t h e R B A N S a n d P A S A T a n d f o u n d n o d i f f e r e n c e b e t w e e n g r o u p s a t b a s e l i n e o r p o s t M D M A o r p l a c e b o . W e a r e r e p e a t i n g t h e s e m e a s u r e i n 2 a d d i t i o n a l s t u d i e s a n d e x p e c t t o c o n f i r m t h e s e f i n d i n g s . I n a l l o f o u r s t u d i e s w e m e a s u r e b l o o d p r e s s u r e p u l s e a n d b o d y t e m p e r a t u r e t h r o u g h t h e s e s s i o n s a n d s o f a r t h a t h a s b e e n n o d i f f e r e n c e i n a v e r a g e V i t a l s i g n s b e t w e e n M D M A a n d P l a c e b o G r o u p R e p e a t a b l e B a t t e r y f o r A s s e s s m e n t o f N e u r o p s y c h o l o g i c a l S t a t u s ( R B A N S ) I m m e d i a t e m e m o r y , d e l a y e d m e m o r y , l a n g u a g e , v i s u o s p a t i a l / c o n s t r u c t i o n a l , a t t e n t i o n P a c e d A u d i t o r y S e r i a l A d d i t i o n T a s k ( P A S A T ) R e y - O s t e r r e i t h C o m p l e x F i g u r e T e s t ( R C F T ) 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 Common Side Effects More common with MDMA:
8 Common Side Effects More common with MDMA: Decreased concentration Jaw Clenching Dizziness Dry mouth Feeling cold Impaired Balance Anxiety More common with inactive placebo: Anxiety Drowsiness Insomnia ********** This is the list of the most common effects in our studies, its in line with what has been reported in the literature from studies in healthy adults. We collect all side effects during the MDMA sessions and for 7 days after or until resolution, Most side effects are mild or moderate in intensity and resolve on the day of or within a few days. If you want to see more adverse event and side effect data we have this detailed in our investigator brochure that is available on our website MDMAPTSD.org Jerome L. (+/-)-3,4-methylenedioxymethamphetamine (MDMA, “Ecstasy”) Investigator’s Brochure. December Accessed Aug. 16, 2012. 8

9 Toxicity in Recreational Users
9 I would like to cover some toxicity data but please not most of this is gathered from poly-drug users in a recreational context, use is often combined with dehydration or over hydration, high ambient temperatures with over exertion. These conditions are not comparable to our clinical research setting or our 3 dose model. However these are the reports that are publicized in the media and they are important, we do include summaries in our investigator brochure. S e r i o u s a c u t e t o x i c i t y a n d M e d i c a l c o m p l i c a t i o n s i n c l u d i n g d e a t h h a v e o c c u r r e d i n t h e s e r e c r e a t i o n a l s e t t i n g s , t h e s e e v e n t s a r e q u i t e r a r e g i v e n t h e m i l l i o n s o f u s e r s . T h e s e c o m p i l a t i o n s a n d d e a t h s h a v e n e v e r o c c u r r e d i n c l i n i c a l s e t t i n g s . S o m e e a r l y s t u d i e s s h o w e d d e c r e a s e s o f s e r o t o n i n r e c e p t o r s i n a n i m a l s a f t e r h i g h o r r e p e a t e d d o s e s o f M D M A a d m i n i s t r a t i o n . H o w e v e r d u e t o t h e n o n l i n e a r m e t a b o l i s m o f M D M A a n d t h e v e r y h i g h d o s e s t h e r e s u l t s w e r e n o t r e l e v a n t t o d o s e s i n h u m a n c l i n i c a l t r i a l s . R e c e n t l y p u b l i s h e d m e t a - a n a l y s i s o f h e a v y e c s t a s y u s e r s w h i c h i s d e f i n e d a s o r m o r e u s e d f o u n d o n l y s m a l l e f f e c t s o n n e u r o c o g n i t i v e f u n c t i o n - a g a i n t h i s i s n o t r e l a t i v e t o o u r m o d e l . M o r e r e c e n t l y a n d m o r e r e l e v a n t t o o u r s t u d i e s i s a P E T S c a n s t u d y o f a c l i n i c a l l y r e l e v a n t d o s e o f M D M A w h i c h s h o w e d n o c h a n g e i n s e r o t o n i n t r a n s p o r t e r b i n d i n g s i t e s f o u r w e e k s a f t e r u s e . M D M A h a s a m o d e r a t e a b u s e p o t e n t i a l , M o n k e y s w i l l s e l f - a d m i n i s t e r i t i n d o s e s e q u i v a l e n t t o o r s l i g h t l y h i g h e r t h a n d o s e s u s e d b y h u m a n s , b u t t h e y r e d u c e t h e i r M D M A i n t a k e o n t h e i r o w n o v e r t i m e . T h e D r u g E n f o r c e m e n t A d m i n i s t r a t i o n w e b s i t e s a y s t h e d a t a s u g g e s t s i t i s o n e o f t h e l e s s a d d i c t i v e r e c r e a t i o n a l d r u g s . O b s e r v a t i o n s f r o m o u r s t u d i e s a t l o n g t e r m f o l l o w u p u s i n g s e l f r e p o r t a n d d r u g t e s t i n g d u r i n g s t u d i e s s u p p o r t t h a t s u b j e c t s d o n o t g o o n t o u s e M D M A r e c r e a t i o n a l l y . S o f a r w e h a v e h a d 1 i n c a s e , t h i s w a s p r i o r t o o u r s w i t c h t o a 3 d o s e m o d e l a n d t h e p e r s o n i n d i c a t e d t h e y w o u l d n o t d o i t a g a i n , t h e y w e r e t r y t o r e c r e a t e t h e t h e r a p e u t i c s e t t i n g a n d i t w a s n o t p o s s i b l e . 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 pdf. Accessed Aug. 16, 2012; Mithoefer MC et al. J Psychopharm. 2011;25(4): ; Mithoefer MC et al. J Psychopharm. 2012; In press. 9

10 In summary we think MDMA is a desirable treatment to study because
Its only used a few times to enhance therapy, It has a desirable effect on brain activity, neurotransmitters and hormones And is has a positive risk benefit profile And It counteracts many PTSD symptoms- this is summarized nicely with a quote from Ralf Metzner: A combined treatment of MDMA with psychotherapy can attenuate the fear response and decrease defensiveness without blocking access to memories while encouraging a deep and genuine experience of emotion. 1010 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 Stage 2 1111 11 12 mn F o l w U O u t c o me O u t c o me
Now lets look at Our basic study design We use a Randomized, Double –blind design and compare either Placebo or active placebo to full dose MDMA of 125mg with optional supplemental half dose at 1.5 hours into the session The treatment is a Combination of drug & non-drug psychotherapy Which is always done by a Male/female team After screening and enrollment there are 3 preparatory sessions MDMA or placebo is administered during 2 or 3 8 hour “experimental session” 3-5 weeks apart These are followed by an Overnight stay And 7 days of follow up phone calls Then there are 3 integrative visits after each experimental session W i t h i n - s u b j e c t c o m p a r i s o n i n c r o s s o v e r a r m a l l o w i n g p l a c e b o s u b j e c t s t o r e c e i v e 3 f u l l d o s e s e s s i o n s a f t e r u n b l i n d i n g E v e r y o n e h a s a 2 m o n t h f o l l o w u p & l o n g - t e r m f o l l o w - u p a t m o n t h s a f t e r t h e i r l a s t s e s s i o n . W e m e a s u r e P T S D s e v e r i t y a t b a s e l i n e , a f t e r t h e s e c o n d a n d t h i r d M D M A s e s s i o n a n d a t a o n e y e a r f o l l o w u p . 1111 Study Design 90- Min Integrative Sessions 90 min Prep Sessions 12 mn F o l w U p O u t c o me O u t c o me 1 1 1 1 Exp Session Exp Session Exp Session Screening/Baseline 2 2 2 2 3 3 3 3 MDMA MDMA or Placebo Stage 2 phone session for 7 days following each experimental session 11

12 Objectives and Measures
1212 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 Our main goal is to Explore safety and efficacy Determine effect size for this subject population ****************** Our Primary Objective is to measure Changes in PTSD symptoms and severity using CAPS after 2 sessions, in our secondary measures we look at symptoms after the third MDMA session and at a one year follow up In addition we have secondary objectives to measure Quality of life, Depression, Post Traumatic Growth, Sleep, Changes in Personality, and most recently we have added measure to look at changes in chronic pain and tinnitus. Our Safety measures include Collection of Adverse Events and serious adverse events, side effects during experimental sessions and for 7 days after, changes in Concomitant Medications, suicidality and Vital signs during experimental sessions Blood pressures- every 30 minutes during experimental session or more if over 160/11 Heart rate every 30 minutes during experimental session more if over 110BPM Body temperature every minutes during experimental session . 12

13 1313 Therapeutic Approach Characterized as non-directive and supportive of the emerging experience Treatment Manual is available at Our therapeutic method is based on a non- directive approach that follows where the subject leads, the therapists maintain an empathetic presence that supports the emerging experience of the participant. Participant are encouraged to fully experience and express whatever arises without avoiding or suppressing feelings or thoughts. There are typically alternating periods of both inner focus as well as talk. Many different types of therapy may arise during the course of the session in response to the needs of the participant. We follow a treatment manual that you can find on our MAPS,org site and we provide 5 day training sessions for all of our therapists to ensure consistency in the treatment method. In the training they learn to integrate the principles of this method with their own experience and intuition as a therapist. After the 5 day therapists can continue training through participation in a phase 1 clinical study. In this study they receive an MDMA experience in a therapeutic context that collects psychological effects in normal volunteers- the study is limited to therapists being trained by us. 13

14 Private Practice Setting
1414 This is the treatment room of our study in South Carolina with with Michael and Annie Mithoefer who conducted our first study and are now doing our Vets study. All of our studies set up a similar space for treatment. you can see a lot of attention has been paid to creating a supportive setting. Participants work with one co therapy team for their whole treatment- they will see the co therapists between times . They spend a lot of intense time in the treatment room during MDMA sessions and integration visits. 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
This is data from our first US study done by Michael and Annie. These subjects had severe treatment resistant PTSD for an average 19 years, The 0-90 scale on the vertical axis represents the severity of PTSD measured by CAPS, A score 50 or above indicates moderate PTSD and was required for entering the study. These subjects started with an average score of 80. They were Mostly women, a few men, and most survivors of sexual abuse, domestic violence, or accidents There was a placebo group which is the blue line compared to a full dose MDMA group of 125mg shown by the bottom red line. The placebo group was able to cross over to full dose MDMA shown by the upper red line. After two MDMA sessions and about 11 total therapy sessions, the means CAPS score in the full dose group represented by the bottom red line dropped to a mean of 30************. Compared to 2 session in the placebo group shown as the blue line with only a small drop in CAPS to a mean score of 70.****** After cross over by the placebo group to 2 full dose session shown as the upper red line their CAPS scores also dropped to a mean of 35 in line with the full dose group ******** Both group then received a 3rd MDMA session and the mean CAPS dropped to 25.****** 8 3 % o f t h e p e o p l e i n t h e s t u d y n o l o n g e r h a d P T S D A s a c o m p a r i s o n , Z o l o f t w a s a p p r o v e d w i t h o n l y a 7 % d r o p i n t h e C A P S , a n d y o u h a v e t o t a k e t h e d r u g e v e r y d a y We completed a long term follow up of these subjects 3.8 Years later and found sustained results 3 people did relapse- permission to treat them with a single additional session and their CAPS scores once again dropped below 50. W e c o m p l e t e d a s i m i l a r s t u d y i n S w i t z e r l a n d w h e r e t h e r e s u l t w e r e n o t a s d r a m a t i c d u e t o t h e s m a l l s a m p l e s i z e b u t t h e y w e r e c l i n i c a l l y s i g n i f i c a n t a n d w e s a w a s i m i l a r e f f e c t s i z e . B o t h o f t h e s e s t u d i e s h a v e b e e n p u b l i s h e d i n t h e J o u r n a l o f P s y c h o m a r m a c o l o g y W e a r e n o w d o i n g s i m i l a r s t u d i e s a t m u l t i p l e s i t e s t o s e e i f t h e r e s u l t s r e m a i n c o n s i s t e n t a n d I c a n s h o w y o u s o m e e a r l y d a t a . 1515 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):

16 1616 I would like to end with a quote from Tony one of the Vets in our current study who After two MDMA treatments felt completely transformed. He said: “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.” He also stopped taking the meds. Tony was so inspired, he has begun to volunteer and tell people about his experience. In fact he wrote a letter for our year end fundraising campaign. Here is what he said at the end of the letter. “ O n e t h i n g I l e a r n e d f r o m t h e m i l i t a r y t h a t I h o l d t r u e i s t h a t y o u n e v e r l e a v e a f a l l e n s o l d i e r b e h i n d . I w i l l n e v e r g i v e u p o n h e l p i n g o t h e r s . M D M A - a s s i s t e d t h e r a p y w o r k e d f o r m e , a n d I t h i n k i t c a n w o r k f o r o t h e r s a s w e l l . W e n e e d e v i d e n c e - b a s e d r e s e a r c h t o h a v e t h e m e d i c i n e s w e n e e d . B y a d d i n g t h i s t o o l , w e c a n h e l p a l o t o f p e o p l e — s u b s t a n t i a l l y . ” “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
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18 Publications of this Work
We can also see these improvement are enduring In our long-term follow-up, we've found that the benefits have, on average, persisted over an average of 3 1/2 years since the last MDMA-assisted psychotherapy session. 2 people did relapse but 88% sustained benefits We have permission to treat the 2 people who relapsed due to a re-triggering of their trauma. 1 has completed a single full dose treatment CAPS: 92 to 18 (80% drop) W e h a v e n o t h a d a n y d r u g - r e l a t e d S e r i o u s A d v e r s e E v e n t s i n o u r s t u d i e s t o d a t e , w e a r e c o l l e c t i n g c o m m o n r e a c t i o n s a n d m o s t f a l l i n l i n e w i t h w h a t i s r e p o r t e d i n t h e l i t e r a t u r e . Y o u c a n r e a d a l l a b o u t t h e s a f e t y p r o f i l e i n o u r i n v e s t i g a t o r b r o c h u r e o n M D M A o n t h e M A P S w e b s i t e . Y o u c a n r e a d m o r e a b o u t t h i s s t u d y i n t h e J o u r n a l o f P s y c h o m a r m a c o l o g y w h e r e t h e r e s u l t s w e r e p u b l i s h e d I n J u l y a n d l o n g - t e r m f o l l o w - u p r e s u l t s h a v e a l s o b e e n a c c e p t e d ( 2 0 J u n 1 2 ) i n t h e s a m e j o u r n a l We also completed our second study in Switzerland where the result were not as dramatic but were clinically significant and we were also able to demonstrate a successful double blind using an active placebo – we did not see any placebo effect in this study. You will be able to read about this in more detail in the J of P in February 1818 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, (4): p 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


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