Evaluating Safety and Effectiveness of Group Versus Individual MDMA-Assisted Therapy for PTSD Diagnosed After October 7, 2023 Events

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of group-based MDMA-assisted therapy compared to individual MDMA-assisted therapy for adults with PTSD diagnosed after the events of October 7, 2023. This trial aims to determine if group-based therapy is not less safe or effective than individual therapy. The study is an open-label, randomized, non-inferiority trial focused on PTSD symptoms and related safety outcomes. Participants will be randomly assigned to receive either group-based or individual MDMA-assisted therapy. MDMA HCl is given orally in divided doses during three dosing sessions, with a supplemental dose 1.5 to 2 hours after the initial dose. Both groups attend preparatory sessions before dosing and integration sessions afterward. Group sessions include up to seven participants sharing the same trauma type. Throughout the study, participants undergo medical and psychiatric screenings, complete questionnaires to assess symptoms, and are monitored closely for adverse events and suicidality using the Columbia-Suicide Severity Rating Scale C-SSRS. Safety assessments include vital signs, ECG, drug tests, and laboratory tests. An external Data Safety Monitoring Board oversees participant safety. The main outcomes measured are changes in PTSD symptom severity from baseline to the end of treatment, with safety and tolerability monitored through the study duration.

Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events