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A Study to Assess the Use of Methylone in the Treatment of PTSD
Sponsor: Transcend Therapeutics
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
Conditions
Interventions
Methylone
Methylone capsules, given orally, once a week for 4 weeks
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