A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)
Post Traumatic Stress Disorder
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring methylone, PTSD, IMPACT-1, Transcend Therapeutics
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) <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.
Sites / Locations
- Mirabilis HealthRecruiting
- Clerkenwell HealthRecruiting
- St. Pancras Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Methylone
Placebo