Drug Scheduling and Breakthrough Therapy
MDMA (3,4 methylenedioxymethamphetamine), the molecule comprising the popular party drug dubbed “Ecstasy,” was cleared by the Food and Drug Administration in August 2017 as a breakthrough therapy for the treatment of Post-Traumatic Stress Disorder.
Breakthrough Therapy Designation was introduced in 2012 as part of the Food and Drug Administration Safety and Innovation Act. “Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions,” according to the FDA. Thus, obtaining breakthrough therapy status means MDMA can be used in FDA-approved clinical trials for treating PTSD, the goal of which is the approval of MDMA for pharmaceutical use. A press release by the Multidisciplinary Association for Psychedelic Studies (MAPS), the organization that ran the clinical trials, states, “MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct.”
In MAPS’s phase 2 trial, “61% of patients no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment.” In addition, according to the 107-participant study, 68% no longer had PTSD in the 12 months following treatment. Participants in phase 2 had suffered from chronic, treatment-resistant PTSD for an average 17.8 years. In fact, MAPS claims an 80 percent success rate for treating PTSD after “years of treatment” with MDMA.
Phase 3 of the MAPS study is scheduled to begin in early 2018, and will include a wider variety of sufferers of PTSD. It will involve 200-300 patients over 18 years of age from the USA, Canada, and Israel. Randomly selected participants will receive either MDMA or a placebo in conjunction with psychotherapy. All participants in the study will undergo “12 associated 90-minute non-drug preparatory and integration sessions.” Upon completion of the study, the results will be assessed and quantified using the Clinician-Administered PTSD Scale (CAPS-5) by a “blinded pool of independent raters.” MAPS’s double-blind phase 3 study is scheduled to conclude in 2021, hopefully garnering FDA approval for MDMA as a prescription treatment for PTSD.
Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorder, as defined by the National Institutes of Health, is “a disorder that develops in some people who have experienced a shocking, scary, or dangerous event.” Various traumatic events that can lead to PTSD include the sudden death of a loved one, fighting in a war, life-threatening illness, or any other event that triggers the brain’s flight-or-fight response, such as rape, a natural disaster, or a car accident. PTSD can occur suddenly following a traumatic event, or it can lay dormant and flare up long after the trauma occurs. It is not yet understood why PTSD has so much variability.
The Sidran Institute Traumatic Stress & Advocacy is a nonprofit that researches the causes of and treatments for PTSD. The Sidran Institute estimates that Post-Traumatic Stress Disorder affects 5 percent of Americans, while an additional 8 percent can be expected to develop PTSD within their lifetimes. Upwards of 70 percent of Americans will experience severe psychological trauma, 20 percent of which will develop into PTSD. Women are twice as likely than men to get PTSD; the Sidran Institute estimates that 1 in 10 women will develop PTSD.
PTSD is diagnosed in people who exhibit certain symptoms over a given period time. Traumatic experiences often leave sufferers with feelings of fear, horror, or helplessness. In cases of prolonged trauma, such as chronic illness, brain chemistry can be altered, leading to the development of PTSD. The Sidran Institute outlines the requirements for a PTSD diagnosis. Symptoms of PTSD are grouped into clusters. Clusters are divided into three families; patients reliving the traumatic event, patients avoiding reminders of the event, and patients who are on guard or hyper-vigilant regarding their surroundings. This is known as hyperarousal, and it is common in soldiers returning home from war. Sadly, PTSD causes twenty veterans to commit suicide every day in the United States (suicide is the leading cause of gun deaths in the US).
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