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

Inclusion Criteria:

• Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with asymptom duration of at least 6 months

• CAPS-5 score of ≥35 at Screening.

• Failed at least one treatment for PTSD (either psychotherapy or pharmacologicaltreatment).

• Proficient in reading and writing in local language sufficient to completequestionnaires.

• 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 asMDMA, 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/cerebrovascularconditions.