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CompletedPhase 1/2

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

Key facts

Who runs it
Transcend Therapeutics
Where
Berlin, Boston, Denver, Jacksonville, Maitland, Murray, Oklahoma City, and Rockville, United StatesSee the 8 sitesAlso in 2 other countries, 8 sites
Status
Completed
Phase
Phase 1/2
People taking part
79 people enrolled
Started
1 Mar 2023
Ended
19 Feb 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Methylone
  • Placebo
Record updated
15 April 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
  • CAPS-5 score of ≥35 at Screening
  • Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment)
  • Proficient in reading and writing in local language sufficient to complete questionnaires
  • Free from any other clinically significant illness or disease

Who cannot take part

  • Current or previous history of clinically significant cardiovascular/cerebrovascular conditions
  • Primary diagnosis of any other DSM-5 disorder
  • Uncontrolled hypertension at Screening
  • Body mass index (BMI) <18 kg/m2 or ≥40 kg/m2
  • Smokes an average of >10 cigarettes and/or e-cigarettes per day
  • Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening
  • Use of an SSRI or other antidepressant within 8 weeks of screening

Where in United States

Also in 2 other countries, 8 sites

  • Cenexel HRIBerlin, United States
  • Boston Clinical TrialsBoston, United States
  • Mountain View Clinical ResearchDenver, United States
  • Clinical Neuroscience Solutions - JacksonvilleJacksonville, United States
  • Maitland, FloridaHospital not named in the registry
  • Cedar Clinical ResearchMurray, United States
  • The Rivus Wellness & Research InstituteOklahoma City, United States
  • Sunstone TherapiesRockville, United States

About the trial

What the trial wants to find out

This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.

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* 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.

The 2 groups in the trial

  • MethyloneTreatment being tested
  • PlaceboPlacebo, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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])
Publications
Record updated
15 April 2026