Transcript The Healing Potential of MDMA

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
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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
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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
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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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