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

Launched by TRANSCEND THERAPEUTICS · Feb 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a substance called methylone to help treat adults with Post-Traumatic Stress Disorder (PTSD). The study aims to determine if methylone is safe, tolerable, and effective for people experiencing moderate to severe PTSD symptoms. It will take place in two parts: the first part will involve up to 15 participants receiving methylone openly, while the second part will include up to 64 participants who will be randomly assigned to receive either methylone or a placebo (a non-active substance) without knowing which one they are getting.

To be eligible for the study, participants must be between the ages of 18 and 75, have been diagnosed with PTSD for at least six months, and have tried at least one other treatment that didn’t work for them. During the trial, participants will take methylone or a placebo once a week for four weeks, followed by a six-week follow-up period where they will attend additional visits to discuss their experiences. It's important to note that certain health conditions and recent use of specific medications or substances may exclude individuals from participating in this trial. If you or someone you know is interested in learning more about this study, it could be a valuable opportunity for those looking for new treatment options for PTSD.

Gender

ALL

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.