Scientific American - USA (2022-02)

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.