This randomized, double-blind, single-site Phase II trial (n=40) will investigate MDMA-assisted therapy’s safety and preliminary efficacy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in veterans with at least moderate PTSD severity.
Randomized, double-blind, single-site Phase II trial in up to 40 veterans comparing MDMA-assisted therapy versus low-dose d-amphetamine-assisted therapy with 1:1 allocation and stratification by gender.
Procedures include screening and baseline CAPS-5, three preparatory therapy sessions, three experimental dosing sessions (flexible divided doses) each followed by an integration session, and follow-up assessments including CAPS-5 for the primary outcome.
Flexible divided-dose MDMA administered in experimental sessions paired with MAPS-style therapy.
Initial 68 or 100 mg, supplemental 34 or 50 mg 1.5–2 h later (equivalents 80/120 mg and 40/60 mg MDMA HCl). Flexible divided-dose per session.
Behavioral: MAPS-trained therapy paired with drug sessions.
Flexible divided low-dose d-amphetamine administered in experimental sessions paired with therapy.
Initial 5 or 10 mg d-amphetamine, supplemental 2.5 or 5 mg 1.5–2 h later (flexible divided-dose).
Behavioral: MAPS-trained therapy paired with drug sessions.