MDMA-Assisted Therapy: A PTSD Breakthrough? (MAPS Phase III Clinical Trial)

Описание: This 6.5 min Micro-Lecture summarizes MAPS' Randomized, Placebo-Controlled Phase III Clinical Tiral of MDMA-Assisted Therapy in Adults with Moderate to Severe PTSD (Mitchel et al., 2023).

I. PTSD's Treatment Chalenge
(1) Gold Standard PTSD Treatment: Trauma-Focussed Psychotherapy.
High dropout rates (18% avg.; confronting trauma is challenging).
(2) Pharmacotherapies.
Expensive, High rates of non-response.
Need for New Treatment Options.

II. MDMA-Assisted Therapy: A Novel Candidate for PTSD Treatment
MDMA combined with structured threapy sessions
...to enhance psychotherapeutic process; enable greater psychotherapy.

III. Therapeutic Hypothesis
MDMA calms brain's fear response.
Creates window of openness for psychotherapeutic processing.

IV. MDMA-Assisted Therapy (MDMA-AT) Protocol
1. Prep Sessions. (Three 90-min therapy sessions without medication).
2. Dosing Sessions. (Three 8-hour sessions with MDMA plus therapy).
3. Integration (Three 90-min sessions to process the experience).

V. Study Design
Randomized: Participants assigned to treatment group randomly.
Placebo-Controlled: Plarticipants Received Either:
(A) MDMA with MDMA-AT Protoocl (II above).
(B) Inactive Placebo with MDMA-AT Protocol (II above).
Double-Blinded: Participants & Researchers Blind to Group Assignments.

VI. Study Participants
104 Adults with Moderate to Severe PTSD.
73% witih severe PTSD; Average duration: 16.2 Years.
Multi-Racial: 43% White; 23% Hispanic/Latino; 34% Other than White.
96% with Comorbid Major Depression; 88% with Suicidal Ideation.

VII. Intervention (n = 53).
MDMA-AT (II Above).
Session 1: 80 mg dose with 40 mg suppplement 1.5 - 2 hrs later.
Sessions 2 & 3: 120 mg dose; 60 mg supplement 1.5 - 2 hrs later.

VIII. Control (n = 51).
Inactive Placebo administered instead of MDMA.
MDMA-AT (but with Placebo)(as outlined in II above).
Split Dosing administered to match MDMA group.

IX. Outcomes
(1) Dropout Rates:
Placebo: 16% dropout (n=8 total; 5 after 1st dosed session).*
MDMA: 2% dropout (n=1; after 3rd session).
*Standard PTSD dropout rates: 18% (Imel et al., 2013).
(2) Blinding Study:
75% of Placebo participants were certain of placebo receipt.
94% of MDMA Participants were certain of MDMA receipt.
(3) Mean Change in CAPS-5 Scores:
CAPS-5: Cliniician-Administered PTSD Scale for DSM-5.
Placebo: −14.8 (−18.28, −11.28). MDMA: −23.7 (−26.94, −20.44). P less than 0.001.
MDMA-AT: 71.2% No longer met diagnostic criteria for PTSD.
MDMA-AT: Twice as likely to achieve full remission.
(4) Mean Change in SDS Score
SDS: Sheehan Disability Scale.
Placebo: −2.1 (−2.89, −1.33). MDMA: −3.3 (−4.03, −2.60). P = 0.03.
(5) Safety:
7% severe treatment-emergent adverse event (TEAE) total (n=7).
Placebo: 3.9% (n = 2). MDMA: 9.4% (n = 5).
No deaths or serious TEAEs.

X. Conclusions: "These data suggest MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated."

Source: Mitchell, J. M., Ot'alora G, M., van der Kolk, B., Shannon, S., Bogenschutz, M., Gelfand, Y., Paleos, C., Nicholas, C. R., Quevedo, S., Balliett, B., Hamilton, S., Mithoefer, M., Kleiman, S., Parker-Guilbert, K., Tzarfaty, K., Harrison, C., de Boer, A., Doblin, R., Yazar-Klosinski, B., & MAPP2 Study Collaborator Group (2023). MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature medicine, 29(10), 2473–2480. https://pmc.ncbi.nlm.nih.gov/articles....
ClinicalTrials.gov identifier: NCT04077437.

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