Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD
This open-label, randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted sessions in U.S. military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic (n=26 actual enrollment); MDMA 120 mg + supplemental 60 mg with manualized psychotherapy.
Details
Open-label, randomized, parallel-group trial comparing two versus three monthly MDMA-assisted psychotherapy sessions (120 mg initial dose with optional 60 mg supplemental) in U.S. military veterans with moderate chronic PTSD; each experimental session is accompanied by manualized psychotherapy.
Protocol includes three preparatory non-drug therapy sessions prior to the first MDMA session and three integrative non-drug therapy sessions after each experimental session; primary outcome is CAPS-5 assessed by a centralized blinded independent rater pool at post-treatment.