NCT05741710

A Study to Assess the Use of Methylone in the Treatment of PTSD

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])

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Transcend Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Methylone	Methylone capsules, given orally, once a week for 4 weeks
DRUG	Placebo	Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-02-19
• Completion: 2025-02-19
• First posted: 2023-02-23
• Last updated: 2026-04-15
• Results posted: 2026-04-15

Locations

16 sites across 3 countries: United States, Ireland, United Kingdom

Regulatory

• FDA-regulated drug study