MDMA, the active ingredient in the party drug ecstasy, is likely to help millions of Americans suffering from post-traumatic stress disorder, according to the Food and Drug Administration. FDA declared MDMA a “Breakthrough Therapy” for PTSD last week, a designation that usually means faster clinical trials and drug approval. The nonprofit financing the therapy, the Multidisciplinary Association for Psychedelic Studies, says that if it can raise the required $25 million to run Phase III trials, we could see MDMA used to treat PTSD in the clinic as soon as 2021.
Phase III trials are the final hurdle to clear before drug approval. That such trials are soon to start is especially good news for parents with PTSD, a condition known to harm children of sufferers. Hard data on how many dads suffer from PTSD is unavailable, but since roughly 7.6 million men in the United States are living with PTSD and about half of all American men are fathers, there could be as many as 3.8 million trauma-stricken dads in the U.S. hoping for a cure.
“Reaching agreement with FDA on the design of our Phase III program and having the ability to work closely with the agency has been a major priority for our team,” Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, wrote in a release. “Our Phase II data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently.”
Moving quickly is crucial, because PTSD—a chronic condition, in which a small trigger such as a sound or smell can bring a traumatic memory to the surface—is one of the most difficult psychiatric conditions to treat. Existing therapies simply do not work for many war veterans and trauma victims, and the tragic result is that some take their own lives. “I’m cautious but hopeful,” Charles Marmar, a psychiatrist at New York University’s Langone School of Medicine told The New York Times after preliminary MDMA studies showed promise. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people.”
But MDMA is a hard sell. Not so much because scientists are worried it won’t work, but because of anti-drug pushback. Strict drug laws in the United States have stymied promising scientific research into the medicinal effects of marijuana, LSD, and ecstasy for decades. That’s one of the reasons why the FDA’s breakthrough designation is so important. “This is not a big scientific step. It’s been obvious for 40 years that these drugs are medicines,” David Nutt, a neuropsychopharmacologist at Imperial College London told Science. “But it’s a huge step in acceptance.”
Prior studies have shown that MDMA can tamp down not a traumatic memory, but turn a patient’s emotional response to that memory into one that borders on euphoric. If nothing else, the drug could offer at least fleeting reprieve for trauma victims who feel trapped by their own thoughts. The treatment that is currently being tested involves several sessions of psychotherapy under the influence of ecstasy, and may help up to 70 percent of long-term PTSD sufferers.
Several challenges remain, however. First, MDMA increases heart rate, blood pressure, and body temperature, which could mean that the treatment is dangerous for patients with certain preexisting conditions. Although there have been no serious adverse effects so far, some experts worry that destigmatizing MDMA is, itself, dangerous. “It sends the message that this drug will help you solve your problems, when often it just creates problems,” Andrew Parrott, a psychologist at Swansea University in Wales, told the New York Times. “This is a messy drug we know can do damage.”
Another challenge is designing an effective placebo. Usually, researchers test a drug by giving some patients a sham pill under the guise of a therapy, just to make sure that those claiming to feel an effect are actually feeling it. But patients can instantly tell that they’ve been given ecstasy—ruining the blind placebo standard. For now, FDA and MAPS have agreed to give some patients sham pills despite this problem, ignoring the fact that the patients cannot truly be blinded.
The single biggest hurdle, however, is funding. MAPS has already raised $12.75 million for the study, but estimates that it will cost closer to $25 million to run the definitive Phase III trial. And efforts to crowd fund the remainder have been disappointing. Regardless, MAPS Executive Director Rick Doblin says the trial will go forward. “We are going to people in the tech world and family foundations, but we’re also trying with the Veterans Administration,” he told Science.
“It’s always been the philosophy of MAPS that if we can do the work, the money will follow.”