Summary: The New York Times Opinion section highlights MDMA-assisted psychotherapy as a promising treatment for PTSD by exploring research results, therapeutic outcomes, and the U.S. Food and Drug Administration (FDA)’s decision to designate MDMA as a Breakthrough Therapy for PTSD. Breakthrough Therapy Designation ensures that the FDA will work closely with MAPS to complete Phase 3 trials as efficiently as possible. "The F.D.A. has clearly identified the extraordinary potential of MDMA-assisted psychotherapy treatment for PTSD," explains op-ed contributor Khaliya of the New York Times.
Khaliya interweaves experimental treatment results with her story about how experiencing underground MDMA-assisted psychotherapy helped her overcome PTSD caused from a violent crime. "MDMA doesn’t just ease the symptoms of PTSD; in the trials to date, MDMA-assisted psychotherapy has also been shown to eliminate the disorder in two-thirds of cases," says Khaliya. "The F.D.A. approval is a beacon of hope for the roughly eight million Americans believed to suffer from PTSD, a group that includes victims of abuse, refugees and combat veterans."
To conclude the op-ed article, Khaliya calls upon the federal government to fund this PTSD research, though MAPS believes that federal funding is not likely.
Originally appearing here.
In July, the Food and Drug Administration took the important step of approving two final-phase clinical trials to determine whether a party drug that has long been on the Drug Enforcement Administration’s Schedule I list of banned substances could be used to treat a psychiatric condition that afflicts millions. The drug is MDMA, a psychedelic commonly known as Ecstasy, previously deemed to have “no currently accepted medical use.” The trials aim to determine whether the drug is, as earlier trials have suggested, a safe and effective treatment for post-traumatic stress disorder, when combined with psychotherapy.
The F.D.A. approval is a beacon of hope for the roughly eight million Americans believed to suffer from PTSD, a group that includes victims of abuse, refugees and combat veterans. The shortcomings in the way we have typically treated PTSD mean that many are condemned to suffer from the condition for years, even decades, with little relief. Less than 20 percent of patients are estimated to get effective treatment through prescription psychiatric drugs like Prozac, Paxil and Zoloft, which, along with psychotherapy, have been the global standard of mental health care since the 1990s.
This could change with the F.D.A.’s decision, which has given MDMA-assisted psychotherapy for the treatment of PTSD the status of a potential “breakthrough therapy.” Based on promising early results, this designation permits the fast-tracking of trials in hopes of proving the drug, which has psychedelic and stimulant effects, to be safe and capable of doing what no other drug on the market can.
I consider myself living proof of the effectiveness of MDMA. A few years ago, I woke up confused and bruised, my head pounding. I had been the victim of a violent robbery. Although I remember little of the attack, the experience shattered me. In public, I kept up appearances. Behind closed doors, I was a wreck. I burst into sobbing fits for no apparent reason. Sleep, when I managed to get any, was filled with nightmares. I had PTSD.
After years of struggling in silence, I began to hear stories about others who had suffered from crippling PTSD, then had their lives transformed by guided therapeutic sessions with MDMA. I knew those offering this underground treatment were breaking the law, but I had to try it. I wanted my mind back. It worked. MDMA-assisted therapy allowed me to overcome the trauma and return to the person I had been before I was attacked.
To be sure, there are risks to MDMA-assisted therapy. Like any drug, MDMA has side effects, which can include sweating, sleeplessness, memory problems, and rapid heartbeat. There’s also a moderate risk of addiction, although it’s much lower with MDMA than with opioids.
Also, finding treatment means resorting to practitioners who are generally well intentioned but not mental health professionals. MDMA itself is still illegal; possession is a felony in some states. Determining the origin of the drug can be a difficult, too, and as with other street drugs, this underground MDMA carries risk of contamination by other, potentially dangerous substances.
All of these considerations make it more urgent to complete the trials and clear the way to safe clinical uses of the drug therapy. With the F.D.A.’s decision, MDMA-assisted psychotherapy has cleared one great hurdle: the regulatory restrictions on conducting research with Schedule I drugs. But another obstacle still stands in the way: money.
Despite the therapy’s promise, the research that paved the way for these final-stage trials was funded exclusively by a small California-based nonprofit, the Multidisciplinary Association for Psychedelic Studies. It raised $15 million for the research that laid the foundation for the final-stage trials, which are expected to cost $26 million. This is a colossal challenge for an organization that relies on private donors. Without better funding, research progress will stall.
To put the amount needed in context, the Department of Veterans Affairs spends about $400 million annually on treating PTSD and other mental health conditions. According to one study from 2008, the estimated total societal costs of veterans suffering from PTSD and major depression is $4 billion to $6 billion.
MDMA doesn’t just ease the symptoms of PTSD; in the trials to date, MDMA-assisted psychotherapy has also been shown to eliminate the disorder in two-thirds of cases.
For people with PTSD, an overactive amygdala, the area of the brain that scientists say produces the “fight, flight or freeze response,” may make people more vulnerable to stress. Some recent fMRI studies of the brain have shown that in people with PTSD, under stress, activity to the prefrontal cortex is diminished as activity in the amygdala increases. In a sense, with PTSD, the reasoning part of the mind gets cut out of the equation.
MDMA, in contrast, reduces blood flow to the regions in the brain linked to fear-based emotions and enhances activity in the prefrontal cortex, which is involved in memory. It also floods the brain with oxytocin and serotonin, “feel good” chemicals that tamp down fear while promoting feelings of trust and empathy.
In contrast to a lifetime of palliative care, this type of intervention could save money and improve lives. Too much is riding on these trials for them to rely on donations from a concerned few. The F.D.A. has clearly identified the extraordinary potential of MDMA-assisted psychotherapy treatment for PTSD. The federal government should back the scientific findings by underwriting the final-stage trials, and potentially bring relief to millions of suffering people.