Research library / Clinical trial
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
Mitchell JM, Ot'alora G M, van der Kolk B, et al. Nature Medicine 2023;29(10):2473-2480
This was the second phase 3 trial of MDMA-assisted therapy for PTSD, run at multiple sites with an ethnically diverse group of 104 adults with moderate to severe PTSD. Everyone received the same therapy; half also received MDMA and half a placebo. Assessors who did not know the group assignments measured PTSD symptoms. Symptoms fell in both groups, and fell further with MDMA: about 24 points on the clinician scale against about 15 with placebo. Daily functioning also improved more. Severe side effects were more common with MDMA, but there were no deaths or serious adverse events. The authors conclude that MDMA-assisted therapy reduced PTSD symptoms and impairment and was generally well tolerated.
What it found
- Clinician-rated PTSD scores (CAPS-5) fell by 23.7 points with MDMA-assisted therapy and by 14.8 points with placebo plus therapy (P<0.001, effect size d=0.7)
- Functional impairment (Sheehan Disability Scale) also improved more with MDMA (-3.3 vs -2.1, P=0.03)
- Severe treatment-emergent adverse events: 5 of 53 (9.4%) on MDMA, 2 of 51 (3.9%) on placebo; no deaths and no serious adverse events