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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tallaght Adult Mental Health Services, Dublin, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylone

Drug

Methylone capsules, given orally, once a week for 4 weeks

Placebo

Drug

Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Primary outcomes

Change From Baseline in CAPS-5 Total Severity Score

Time frame: up to 10 weeks

CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.

Sponsors and collaborators

Lead sponsor

Transcend Therapeutics

Industry

Registry information

Official study 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])

Acronym: IMPACT-1

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Feb 23, 2023
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed