Clinical Evidence for the Use of Methylone in the Treatment of PTSD: A Case Series with Long-Term Follow- Up

Kelmendi B1,2,3*, Pittenger C1,4, Ching THW1, Farré M5,6, Mandell B3, Stogniew M3, Seelig M7 and Averill LA1,2,8,9

1Department of Psychiatry, Yale School of Medicine, USA 2Department of Veterans Affairs, National Center for PTSD – Clinical Neurosciences Division, USA 3Transcend Therapeutics, New York, USA 4Yale School of Medicine, Yale Child Study Center, USA 5Clinical Pharmacology Unit, Hospital Universitari Germans Trias i Pujol-Institut de Recerca Germans Trias i Pujol (HUGTiP-IGTP), Badalona, Spain 6Department of Pharmacology, Therapeutics and Toxicology and Department of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain 7Usona Institute, Madison, USA 8Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, USA 9Department of Veterans Affairs, Michael E. DeBakey VA Medical Center, USA

^*Correspondance to: Kelmendi B 

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Abstract:

Background: The Rapid Acting Empathogen (RAE) 3,4-methylenedioxy-N-methylcathinone (methylone; also known as MDMC, βk-MDMA, and M1), is a phenethylamine compound with chemical and pharmacological similarities to 3,4-Methylenedioxymethamphetamine (MDMA). It has been used outside of medical settings to treat Posttraumatic Stress Disorder (PTSD) and depression with encouraging preliminary clinical outcomes. A recent observational study comparing the acute effects of methylone and MDMA in healthy participants reported that while the subjective drug effects of the two drugs were categorically similar, methylone demonstrated significant clinical, physiological, and pharmacological differences, including “softer” empathogenic and psychostimulant effects that may have potential for accelerated adoption across a broader range of medical settings and clinical applications. Objective: Here we present clinical experience with 21 patients (57% female) treated with one or more oral doses of methylone for PTSD in a naturalistic setting. Methods: Archival data was used to examine patient characteristics. Results: Methylone was well tolerated. All patients achieved at least “minimal improvement” following treatment and 81% were “much” or “very much” improved on the Clinician Global Impressions Scale. Conclusion: There is an urgent need for rapid-acting and robust interventions for PTSD. These promising acute therapeutic outcomes warrant controlled trials to further characterize the role of methylone as a monotherapy and augmentation in the pharmacotherapy of PTSD.

Keywords:

Posttraumatic stress disorder; PTSD; Methylone; Treatment; Case series; Rapid Acting Empathogen (RAE)

Cite the Article:

Kelmendi B, Pittenger C, Ching T, Magí Farré, Mandell B, Stogniew M, et al. Clinical Evidence for the Use of Methylone in the Treatment of PTSD: A Case Series with Long-Term Follow-Up. Ann Clin Case Rep. 2022; 7: 2209..