At a glance
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A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
In Brief
A Phase 2 clinical trial evaluating Methylone and Placebo for Post Traumatic Stress Disorder. Completed, enrolled 79 participants across 16 sites in 3 countries.
Detailed Summary
This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts. * Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.
Study Details
Timeline
Interventions
Methylone capsules, given orally, once a week for 4 weeks
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B