MDMA, commonly known as Ecstasy or Molly, has been shown to help those suffering from severe post-traumatic stress disorder when combined with talk therapy.
As compared with those who received therapy and a placebo, those who received MDMA during therapy experienced a significantly greater reduction in the severity of their symptoms, according to the new study, which will be published later this month in Nature Medicine. In the MDMA group, 67 percent of participants no longer qualified for a diagnosis of PTSD after two months, while 32 percent in the placebo group did.
There were no serious side effects associated with MDMA. Symptoms such as nausea and loss of appetite were temporarily experienced by some participants.
A neuroscientist at Johns Hopkins University School of Medicine, who was not involved in the study, said, “This is about as excited as I can get about a clinical trial.” Clinical trial results for neuropsychiatric diseases don’t compare to this.
A second Phase 3 trial with 100 participants is needed before MDMA-assisted therapy can be approved for therapeutic use by the Food and Drug Administration. By 2023, approval may be granted.
According to mental health experts, the first Phase 3 trial on psychedelic-assisted therapy could pave the way for further research into MDMA’s potential in treating other hard-to-treat mental health conditions, including substance abuse, obsessive compulsive disorder, phobias, eating disorders, depression, end-of-life anxiety and social anxiety in autistic adults.
According to mental health researchers, these studies could also inspire further research on banned psychedelics like psilocybin, LSD, and mescaline.
“This is a wonderful, fruitful time for discovery, because people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years,” said Jennifer Mitchell, lead author of the new study at the University of California, San Francisco.
However, some mental health experts urged restraint. Psychiatrist Allen James Frances, who was not involved in the new study, said new treatments “are never as wonderful as they seem at first.”
“New treatments in medicine have always had a temporary halo effect just because they are new and promise more than they can deliver,” Doctor said.
In contrast to traditional pharmaceuticals, MDMA does not work as a band-aid to treat PTSD symptoms. As a result, MDMA combined with therapy seems to be able to help people with PTSD process painful memories and heal themselves, according to Doctor.
It is important to note that MDMA taken in isolation, without therapy, does not automatically produce positive effects.
“It’s not the drug that works, it’s the therapy enhanced by the drug,” said Rick Doblin, senior author of the study and director of the Multidisciplinary Association for Psychedelic Studies.
A person must be primed to engage with their trauma in order for this process to work. Two trained therapists conducted preparatory sessions with participants. A month apart, they received either an inactive placebo or MDMA in three eight-hour sessions. Neither the participants nor the therapists knew which was which. This did not undermine the study’s results or methodology, which were approved by the FDA in advance, despite most participants guessing correctly whether they received a placebo or MDMA.
The study participant, Scott Ostrom, had suffered from PTSD since returning home from his second deployment in Iraq in 2007. He suffered from debilitating nightmares for more than a decade. “Bullets would drip from my gun, or I would get separated from my team and get lost in a town where insurgents were watching me,” he said.
Panic attacks punctuated Mr. Ostrom’s college days, and he dropped out. As a result, he distanced himself from friends and family, and got involved in an unhealthy romantic relationship. In addition to assault charges, he was charged with attempted suicide as well. It was not possible to get better with therapy or medication.
He no longer has nightmares after participating in the trial. “I’m a completely different person,” he said.
A spinning, oily black ball appeared to Mr. Ostrom during his first of three sessions in early 2019. Each layer of the ball was a memory, like the layers of an onion. During the next two sessions, Mr. Ostrom engaged with his PTSD alter ego, “the bully,” as he calls it, and asked for permission for Scott to return.
A 36-year-old HVAC specialist, Mr. Ostrom now lives near Boulder, Colo., with his girlfriend, Jamie Ehrenkranz, and his service dog, Tim, an English lab.
According to Mr. Ostrom, the reason I like calling this medicine medicine is that it stimulated my own consciousness’s ability to heal. When you experience unconditional love for yourself, you understand why it’s ok.”
In 1912, Merck pharmacists invented MDMA, or 3,4-methylenedioxy-N-methylamphetamine. However, the compound was largely forgotten until 1976, when Alexander Shulgin, a well-known psychedelic chemist, synthesized MDMA. In 1977, Doctor shared MDMA with Leo Zeff, a psychotherapist who introduced it to other mental health professionals. It is estimated that half a million doses of MDMA were administered over the next eight years by hundreds of therapists and others. It has been reported that some patients achieved progress in just a few sessions with the medication.
MDMA, however, escaped from the clinic and became Ecstasy on the dance floor in the 1980s. It was criminalized as a Schedule I substance by the Drug Enforcement Administration in 1985 because it had “no currently accepted medical use and a high potential for abuse.”
While some mental health professionals continued to administer MDMA-assisted therapy underground, most stopped. As a result, fewer scientists pursued studies with MDMA. Nonetheless, a few individuals continued to advocate strongly for MDMA research, including Doctor, who founded his association in 1986 in order to develop MDMA and other psychedelic drugs into FDA-approved drugs. It took nearly two decades to overcome alarmist claims about Ecstasy’s dangers, including that it ate holes in users’ brains, to gain approval to begin studies. At the doses administered in clinical trials, MDMA does not cause neurotoxic effects in animals or humans.
However, Ecstasy or Molly can be adulterated with other potentially harmful substances, and users may take higher doses than are safe. According to a database maintained by the Substance Abuse and Mental Health Services Administration, MDMA accounted for 1.8 percent of all U.S. drug-related emergency department visits in 2011. From 2013 to 2014, MDMA was responsible for 8 percent of drug-related emergency visits to 16 major hospitals in 10 countries.
MDMA’s therapeutic effects remain a mystery to scientists. The substance binds to proteins that regulate serotonin, a neurotransmitter that, among other things, lifts mood. Prozac and other antidepressants bind to these same proteins and block their reabsorption of serotonin, but MDMA stimulates these proteins to pump serotonin into synapses, enhancing their chemical activity.
Additionally, MDMA elevates levels of oxytocin, dopamine and other chemical messengers, producing feelings of empathy, trust, and compassion.
But its primary therapeutic effect may result from its ability to reopen what neuroscientists call the “critical period,” the period during childhood when the brain is more capable of making and storing memories. According to a study published in Nature in 2019, MDMA may restore the malleability of the adult brain.
In the United States, 7 percent of the population will experience PTSD at some point in their lives, and 13 percent of combat veterans suffer from it. During 2018, over one million veterans with post-traumatic stress disorder received disability payments from the Department of Veterans Affairs.
A half-to-one-third of those who do not find relief through treatment can develop chronic PTSD, lasting for years or even a lifetime.
The Phase 3 trial included 90 participants, including combat veterans, first responders, victims of sexual assault, mass shootings, domestic violence, or childhood trauma. The average diagnosis of PTSD was 14 years old, with all of them suffering from severe PTSD. 90 percent had considered suicide, and many had a history of alcohol and substance abuse disorder. A total of 80 therapists collected data at 15 sites in the United States, Canada, and Israel as part of the study.
In spite of the fact that three quarters of the trial participants were white, Albert Garcia-Romeu, a psychopharmacology researcher at Johns Hopkins University School of Medicine, said that more research is needed to determine whether the therapy is effective for people of diverse racial and ethnic backgrounds. Furthermore, he said, people of color and those with lower socioeconomic status, who already suffer from health disparities and trauma, should have access to these treatments.
However, Doctor said the findings “make a clear case for medical approval,” something that “could revolutionize health care.”
Among the patients who benefited from the drug is Nathan McGee, 43. He has been in and out of therapy and on and off depression and anxiety medications since he was a teenager.
“I was always angry without reason,” he said. An event that occurred when Mr. McGee was 4 years old caused him to develop PTSD in 2019.
At first, he thought he had received a placebo as a trial participant. He felt himself moving inward about an hour into his first session at a Boulder, Colo., study site.
Mr. McGee was able to revisit his traumatic memory through the eyes of his 4-year-old self while under the influence of MDMA and guided by his therapists.
“I was able to accept myself and recognize who I was as a result,” he said.
As a result of taking part in the trial in early 2020, he is less easily enraged and is able to enjoy the experience more.
McGee said he is constantly learning new things and improving. “It has given me a deeper understanding of joy.”