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Could a party drug ease PTSD? new trial tests methylone

NCT ID NCT05741710

Symptom relief Sponsor: Transcend Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether methylone, a substance similar to MDMA, can safely reduce PTSD symptoms in adults. 79 participants with moderate to severe PTSD received either methylone or a placebo once a week for four weeks, then were followed for six more weeks. The goal was to see if the drug helps lower symptom severity and is well-tolerated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

79 people

The number who actually took part.

Started

Mar 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Primary diagnosis of any other DSM-5 disorder * Body mass index (BMI) \<18 kg/m2 or ≥40 kg/m2. * Smokes an average of \>10 cigarettes and/or e-cigarettes per day * Uncontrolled hypertension at Screening * 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. * Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

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Conditions

The condition(s) this trial relates to.

post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post traumatic stress disorder

Contacts and locations

Locations

  • Accel Research Sites

    Maitland, Florida, 32751, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, United Kingdom

  • Cedar Clinical Research

    Murray, Utah, 84107, United States

  • Cenexel HRI

    Berlin, New Jersey, 08009, United States

  • Clerkenwell Health

    London, United Kingdom

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida, 32256, United States

  • Glasgow Clinical Research Facility, QEUH

    Glasgow, United Kingdom

  • King's College

    London, United Kingdom

  • La Nua Day Hospital Mental Health Centre

    Galway, Ireland

  • Mirabilis Health

    Belfast, Northern Ireland, United Kingdom

  • Mountain View Clinical Research

    Denver, Colorado, 80209, United States

  • Oxford Health NHS Foundation Trust

    Oxford, United Kingdom

  • Sunstone Therapies

    Rockville, Maryland, 20850, United States

  • Tallaght Adult Mental Health Services

    Dublin, Ireland

  • The Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma, 73112, United States

More trials for these conditions

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