MDMA for active-duty troops: Aaron Wolfgang on DoD’s unprecedented study

Josh Hardiman of Psychedelic Alpha reports on an interview with Aaron Wolfgang, Chief of Inpatient Psychiatry at the US Army, about a first-ever clinical trial of MDMA-assisted therapy for active-duty service members with PTSD. He writes: "The landmark trial, funded via the Defense Appropriations Act, has a number of interesting features. Those include the use of D-amphetamine as a control, a combination of the Lykos Therapeutics model as well as Acceptance and Commitment Therapy (ACT), and a Simultaneous Dosing Paradigm, to name just a few. The project is currently titled A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Safety and Efficacy of MDMA-Assisted Therapy for Active Duty Service Members with PTSD. 3 dosing sessions: MDMA at 80mg, 120mg for 2nd dose, and 3rd dose with flexibility to go with 80 or 120mg depending on shared decision-making between participant and study team – similar to the Phase 3 studies. Control will be D-amphetamine; it was a close call between D-amphetamine and low-dose MDMA since there’s decent evidence and rationale to support either, but the deciding factor was that one of our key secondary outcomes is looking at cardiac safety which we believe needs to be better characterized. And given D-amphetamine is already FDA-approved with a well-characterized cardiac profile, that was the deciding factor."

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