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COMPLETED
NCT05741710
PHASE1/PHASE2

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

Sponsor: Transcend Therapeutics

View on ClinicalTrials.gov

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.

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])

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

79

Start Date

2023-03-01

Completion Date

2025-02-19

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

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

Locations (16)

Mountain View Clinical Research

Denver, Colorado, United States

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, United States

Accel Research Sites

Maitland, Florida, United States

Sunstone Therapies

Rockville, Maryland, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Cenexel HRI

Berlin, New Jersey, United States

The Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, United States

Cedar Clinical Research

Murray, Utah, United States

Tallaght Adult Mental Health Services

Dublin, Ireland

La Nua Day Hospital Mental Health Centre

Galway, Ireland

Mirabilis Health

Belfast, Northern Ireland, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Glasgow Clinical Research Facility, QEUH

Glasgow, United Kingdom

Clerkenwell Health

London, United Kingdom

King's College

London, United Kingdom

Oxford Health NHS Foundation Trust

Oxford, United Kingdom