Phase 2
Completed N=79
A Study to Assess the Use of Methylone in the Treatment of PTSD
Source: ClinicalTrials.gov NCT05741710 ↗Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Apr 2026
Primary outcomePrimary: Change From Baseline in CAPS-5 Total Severity Score — -36.2; -23.3; -13.6 points — p=0.011
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in CAPS-5 Total Severity Score |
-36.2; -23.3; -13.6 | 0.011 sig |
Eligibility Criteria
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) 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.
Data sourced from ClinicalTrials.gov (NCT05741710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.