Graphic by 5W Infographics February 2022, ScientificAmerican.com 59
Source: “MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled
Phase 3 Study,” by Jennifer M. Mitchell et al., in
Nature Medicine,
Vol. 27; June 2021
Screening
1331 preliminary
phone screening
345
further
screening
131 enrolled
91 confirmed for randomization
1 withdrew
46 randomly assigned to MDMA 44 randomly assigned to placebo
Enrollment
Study Termination
Assessment Assessment Assessment Assessment
Week number: -1 0 1 4 5 8 9 18
Three Preparatory Sessions
90-minute therapy sessions to establish
trust and provide guidance on how to
respond to the memories and feelings
that could arise during treatment
Three Experimental Sessions
Eight-hour experimental sessions
of either MDMA-assisted
therapy or therapy with inactive
placebo control
Nine Integration Sessions
Each experimental session was followed by three
90-minute integration sessions, spaced about one
week apart, to allow the participants to understand
and incorporate their experience
Participant
Selection
Tapering off
psychiatric
medications
RESULTS
After One Session
MDMA-Assisted Therapy Placebo with Therapy
After Two Sessions
After Three Sessions
Nonresponders
= 1 participant
Responders who improve but retain a PTSD diagnosis
No longer diagnosed with PTSD
Participant withdrawal
met criteria for remission
(vs. 5% in placebo group)
of the participants in the MDMA group no longer
met the diagnostic criteria for PTSD
(vs. 32% in placebo group)
67%
33%
Loss of diagnosis
Remission
15 10 5 00 5 10 15 20 25
A Daunting Trek toward fda Approval
Revived interest in psychedelics for psychiatric disorders brought
an immediate focus on MDMA as a possible treatment for
intractable post-traumatic stress disorder (PTSD). A major
challenge in conducting this type of research relates to the legal
legacy of psychedelics, classified by regulators as recreational
drugs of abuse with no medical use. To legitimize their use, the
Multidisciplinary Association for Psychedelic Studies (MAPS)
has undertaken a 20-year MDMA research program, some of it
with crowdsourced funding. MAPS formulated an intricate
study protocol involving 15 study sites across three countries
with over 70 therapists. The researchers reported last May the
results of the first-ever, late-stage clinical trial for a psychedelic.
The phase 3 study showed a major benefit for PTSD patients
and may be a model for future psychedelic studies. Here is a
look at the study protocol devised by MAPS in preparation for
a possible 2023 application for FDA approval.
PARTICIPANT SELECTION An attempt was made to recruit participants
from diverse backgrounds and cultures who had had PTSD for many years.
TIME LINE The protocol for the phase 3 study administered three doses of MDMA in conjunction with therapy sessions over the course of 18 weeks.