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 PTSDPart B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSDEligible 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.

Inclusion Criteria:Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 monthsCAPS-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 diseaseExclusion Criteria:Primary diagnosis of any other DSM-5 disorderBody mass index (BMI) <18 kg/m2 or ≥40 kg/m2.Smokes an average of >10 cigarettes and/or e-cigarettes per dayUncontrolled hypertension at ScreeningUse 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.