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A Study to Assess the Use of Methylone in the Treatment of PTSD — IMPACT-1  

Post Traumatic Stress Disorder Clinical Trial

Official title:
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])

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05741710
Study type Interventional
Source Transcend Therapeutics
Contact Study Director
Phone 650-769-6472
Email amanda@transcendtherapeutics.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 1, 2023
Completion date December 2024
View Details
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