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An Ecstatic Update on Phase III Trials for Possible PTSD Treatment

Written by Dominic Javonillo

In late August, the U.S. Food and Drug Administration (FDA) designated the use of MDMA (commonly known as “ecstasy”) as a form of breakthrough therapy in treating post-traumatic stress disorder (PTSD). Through a press release, the Multidisciplinary Association for Psychedelic Studies (MAPS)—a research organization searching for advantages in safe consumption of psychedelic drugs—announced its collaboration with the FDA in examining psychotherapies using MDMA on thousands of PTSD patients through Phase III Trials, the final set of clinical trials on human subjects before awaiting final FDA approval for treatment [1].

PTSD debilitates individuals following a highly traumatic event. This anxiety and stress condition is predominantly characterized by the chronic re-emergence of aversive memories through related stimuli [2]. In healthy individuals confronting negative memories, their fear response becomes weaker when the anticipated threats fail to occur—that is, when the stimulus producing the fear is unharmful [3]. This reduction in fear response becomes impaired in PTSD patients re-experiencing their trauma [3]. Current psychotherapies rely on collaborative efforts between the patient and the therapist, in such as engaging with repeated exposure to traumatic stimuli without harmful outcomes [2]. Unfortunately, these practices often lead to high treatment-resistance and dropout rates due to the overwhelming stress and the lack of trusting relationships with therapists [2, 4]. With very few approved pharmaceuticals to treat PTSD, a drug that diminishes fear response would significantly improve benefit current psychotherapies while improving trust formation between patients and therapists [24].

Fortunately, prior research has found that MDMA acts on specific receptors in the brain that induce effects that may significantly improve psychotherapeutic treatment of PTSD where current therapies fail. 3,4-methylenedioxymethanphetamine (MDMA) is an illegal form of methamphetamine that acts primarily on membrane transporters of serotonin, a neurotransmitter used for communication between brain cells [2]. It interacts with a specific transporter that increases levels of serotonin surrounding neurons to diminish feelings of depression and increase positivity [4].  A recent study found that MDMA’s interaction with serotonin plays a key role in diminishing fear responses [3]. In addition to accumulating serotonin, MDMA also releases oxytocin, which initiates emotional attachments and enhances trust and empathy [4].

With MDMA facilitating much-needed effects in improving treatment and psychotherapies for individuals with PTSD, it is useful to learn that its recent clinical trials are producing substantial results. After consuming controlled amounts of MDMA before therapy sessions with therapists, 85% of patients within a small sample no longer met criteria for PTSD and sustained this outcome for the next four years [4]. In a larger clinical study, similar results were reproduced and set the course for the current Phase III trials underway. FDA approval is projected to arrive in 2021 and it is important to emphasize that MDMA will be treated simultaneously with current psychotherapy techniques for PTSD [4]. However, gaining FDA approval will not be without social obstacles, considering MDMA’s illegal status around the world. Despite the controversy surrounding research on illegal drugs, the advancements in MDMA studies show significant promise for the substantial treatment of PTSD and in combatting mental health disorders.

References:

1. Burge, Brad. “PRESS RELEASE: FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD, Agrees on Special protocol Assessment for Phase 3 Trials.” Multidisciplinary Association for Psychedelic Studies. Web. 16 October 2017.
2. Amoroso T. 2015. The Psychopharmacology of ±3,4, Methylenedioxymethamphetamine and its Role in the Treatment of Posttraumatic Stress Disorder. Journal of Psychoactive Drugs47:337-344.
3. Young M.B., Norrholm S.D., Khoury L.M., Jovanovic T, Rauch S.A.M., Reiff C.M., Dunlop B.W., Rothbaum B.O., Howell L.L. 2017. Inhibition of serotonin transporters disrupts enhancement of fear memory extinction by 3,4-methylenedioxymethamphetamine (MDMA). Psychopharmacology234:2883-2895.
4. Sessa, B. 2016. MDMA and PTSD treatment “PTSD: From novel pathophysiology to innovative therapeutics.” Neuroscience Letters649:176-180.

Published in Medicine

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