An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Public ClinicalTrials.gov record NCT06215261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts. * Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
Study identification
- NCT ID
- NCT06215261
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2024
- Primary completion
- Sep 22, 2025
- Completion
- Sep 22, 2025
- Last update posted
- Nov 24, 2025
2024 – 2025
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Segal Trials | Lauderhill | Florida | 33319 | — |
| Accel Research | Maitland | Florida | 32751 | — |
| CNS Healthcare | Orlando | Florida | 32801 | — |
| Uptown Clinical Research | Chicago | Illinois | 60640 | — |
| Sunstone Medical | Rockville | Maryland | 20850 | — |
| Redbird Research LLC | Las Vegas | Nevada | 89119 | — |
| Numinus | Draper | Utah | 84020 | — |
| Seattle NTC | Bellevue | Washington | 98004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06215261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 24, 2025 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06215261 live on ClinicalTrials.gov.