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First human test of methylone for PTSD begins

NCT ID NCT06303648

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested the safety and drug levels of methylone in 40 healthy volunteers aged 25 to 55. Participants received a single oral dose of methylone or a placebo. The study measured how the drug moves through the body and checked for side effects. This is a first step toward possibly using methylone to treat PTSD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylone
What this could lead to
If successful, this could pave the way for future studies testing methylone as a treatment for PTSD.
What could go wrong
This is a very early Phase 1 safety study in healthy people, not patients. It only measures drug levels and safety, not whether methylone works for PTSD. Many early-stage drugs fail to show benefit later.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 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

25 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Key Inclusion Criteria: * Healthy adult male or female aged 25 to 55 inclusive * Normal resting ECG * Normal hematologic and hepatic function * Normal renal function Key Exclusion Criteria: * Vital sign abnormalities * Positive urine drug screen at screening and / or Day -1 * Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders

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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

  • CMAX Clinical Research

    Adelaide, South Australia, 5000, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.