A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments with Methylone for the Treatment of PTSD

People who completed a prior clinical trial for PTSD using the drug methylone can now enrol in a year-long follow-up study to see if the treatment’s effects last. This matters because PTSD often returns after treatment ends. The earlier trials (IMPACT-1 and IMPACT-2) tested methylone—a synthetic drug related to MDMA—over a short period, but no one knows whether a single or repeated course keeps symptoms away for months. This 52-week extension study fills that gap by checking participants every four weeks for signs of relapse. If the research succeeds, it could change how clinicians manage long-term PTSD care. Instead of open-ended therapy or repeated hospital visits, doctors might offer a defined course of methylone, then monitor for relapse and re-treat only when needed. That would reduce the burden on mental health services and give patients a clearer, less disruptive treatment path. The study is a practical extension of existing clinical work, not fundamental science. Its direct impact will be on treatment protocols and patient quality of life—specifically, whether a drug-based intervention can keep PTSD at bay for a full year without constant dosing.