clinical trial · NCT06215261
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Post Traumatic Stress DisorderMethylone
brief summary
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts. * Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
started
Apr 4, 2024
primary completion
Sep 23, 2025
completion
Sep 23, 2025
last updated
Nov 25, 2025
official title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol