The Healing Potential of MDMA

Report
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?
Obstacles to treating
PTSD
MDMA Diminishes the
Obstacles:
Fear
Decrease fear and defensiveness
Hyper vigilance
Increase trust and empathy
Defensiveness / numbing
Provide Affirming experiences
Lack of trust
More realistic perspective about
present circumstances/safety
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
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Amygdala and Prefrontal Cortex
PTSD
Mediated by emotional
memory- increased
amygdala activity
MDMA
Reduces fear &
suppresses activity in
amygdala
Rauch SL et al. Biol Psychiatry. 2006;60(4):376-382, Gamma et al. 2000
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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:
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
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
4
A Window of Tolerance
Hyperarousal Zone
•
Increased sensation
•
Emotional reactivity
•
Intrusive imagery
•
Disorganized cognitive processing
Window of Tolerance / Optimal Arousal Zone
Hypoarousal Zone
•
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
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“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
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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 PASAT
No change pre and post MDMA or placebo
•Changes in Vital signs during sessions similar between
MDMA and Placebo Group
7
Common Side Effects
More common with MDMA:
Decreased concentration
Jaw Clenching
Dizziness
Dry mouth
More common with
inactive placebo:
Anxiety
Drowsiness
Insomnia
Feeling cold
Impaired Balance
Anxiety
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.
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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
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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
90 min Prep
Sessions
90- Min
Integrative
Sessions
1
1
Screening/
Baseline
1
2
2
3
12
mn
Exp
Session
MDMA or
Placebo
3
2
Exp
Sessio
n
3
O
u
t
c
o
m
e
1
2
Exp
Session
3
MDMA
O
u
t
c
o
m
e
F
o
l
l
o
w
U
p
Stage 2
phone session for 7 days following each experimental session
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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
Private Practice Setting
ER Doctor Psychiatrist,
IFS, Holotropic Breathwork
Assistant Clinical Professor
Medical University of South Carolina
Psychiatric Nurse
Holotropic Breathwork
Hakomi
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PTSD Severity-Mean CAPS Score
by Group after MDMA or Placebo
Baseline
Session 3
Post Session 2 Placebo/Active
Post
Mithoefer MC et al. J Psychopharm. 2011;25(4):439-452
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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, YazarKlosinski, BB, Michel, Y, Brewerton, T, Doblin, R. Durability of
Improvement in Posttraumatic Stress Disorder Symptoms and Absence of
Harmful Effects or Drug Dependency after {+/-}3,4methylenedioxymethamphetamine-assisted psychotherapy: A Prospective
Long-term Follow-up Study. J Psychopharmacol, Epub online 2012, Nov 20.
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