MDMA-Assisted Therapy

The originally published report (1) presented results from multiple studies performed in our laboratory over a span of approximately 2 years demonstrating that a novel systemic dose regimen of what we believed was MDMA produced severe dopamine neurotoxicity in two species of nonhuman primates, in addition to the previously reported serotonin neurotoxicity (3–6). Subsequent to the publication of those findings, we were unable to extend the dopamine neurotoxicity to orally administered doses. Multiple subsequent attempts to reproduce the original findings with systemically administered doses of MDMA identical to those used in the original study were also unsuccessful, under a variety of laboratory conditions.

MDMA is under investigation as an adjunct to psychotherapy for various anxiety-related conditions. Compelling results from six Phase 2 studies led the FDA to issue a Breakthrough Therapy designation for MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD) in 201716. In the Phase 2 trials, participants who were given active-dose MDMA (75–125 mg) and psychotherapy experienced significantly greater reductions in PTSD symptoms when compared with participants given inactive placebo or low-dose MDMA (0–40 mg)17,18,19,20,21. MDMA-assisted psychotherapy also reduced symptoms of depression and improved sleep quality. A study of MDMA-assisted psychotherapy in autistic adults with social anxiety also found significantly greater improvement in Leibowitz Social Anxiety Scale (LSAS) Total scores in the MDMA group compared to the placebo group22.