In an important step towards medical approval, MDMA, the illegal drug popularly known as ecstasy or molly, was shown to bring relief to those suffering from severe post-traumatic stress disorder when paired with talk therapy.
Of the 90 people who participated in the new study, which is expected to be published later this month in Nature Medicine, those who received MDMA during treatment experienced a significantly greater reduction in the severity of their symptoms compared to those who received treatment. and an inactive placebo. Two months after treatment, 67% of MDMA participants no longer qualified for a diagnosis of PTSD, compared with 32% in the placebo group.
MDMA produced no serious side effects. Some participants temporarily experienced mild symptoms such as nausea and loss of appetite.
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“This is about as excited as I can get a clinical trial,” said Gul Dolen, a neuroscientist at Johns Hopkins University School of Medicine who was not involved in the research. “There is nothing like this in clinical trials for a neuropsychiatric disease.”
Before MDMA-assisted therapy can be approved for therapeutic use, the Food and Drug Administration needs another positive phase 3 trial, which is currently underway with 100 participants. Approval could come as early as 2023.
Mental health experts say this research – the first Phase 3 trial conducted on psychedelic-assisted therapy – could pave the way for further studies of MDMA’s potential to help address other difficult therapeutic mental conditions, including substance abuse, obsessive-compulsive disorder, phobias, eating disorders, depression, life anxiety and social anxiety in autistic adults.
And psychiatric researchers say these studies may also encourage further research into other banned psychedelics, including psilocybin, LSD and mescaline.
“This is a wonderful, fruitful time for discovery because people are suddenly willing to consider these drugs as drugs again, which has not happened in 50 years,” said Jennifer Mitchell, a neuroscience at the University of California, San Francisco, and lead author. of the new study.
But some psychic experts called for restraint. Allen James Frances, professor emeritus and former president of psychiatry at Duke University, who was not involved in the new study, warned that new treatments “are never as wonderful as they seem at first.”
“All new treatments in medicine have always had a temporary halo effect by virtue of being new and by promising more than they can possibly deliver,” Frances said.
Unlike traditional drugs, MDMA does not act as a band-aid that attempts to dull symptoms of PTSD. Instead, MDMA combined with therapy in people with PTSD seems to allow the brain to process painful memories and heal itself, Mitchell said.
Critically, MDMA isolated without treatment does not automatically produce a beneficial effect.
“It’s not the drug – it’s the therapy that enhances the drug,” said Rick Doblin, senior author of the study and director of the Multidisciplinary Association for Psychedelic Studies, a nonprofit research group that sponsored and funded the clinical trials.
For this process to work, a person must be ready to engage in their trauma. Participants first conducted preparatory sessions with two trained therapists. Then, in three sessions of eight hours each, they received either an inactive placebo or MDMA at one-month intervals. Neither the participants nor the therapists knew which one. While most participants correctly guessed whether they were receiving placebo or MDMA, this did not undermine the results of the study or its method agreed upon by the FDA in advance.
Scott Ostrom, who participated in the study, has suffered from PTSD since returning home from his second deployment in Iraq in 2007. For more than a decade, he experienced debilitating nightmares. “Bullets drip out of the end of my gun, otherwise I will be separated from my team and lost in a city where rebels saw me,” he said.
Ostrom’s days were punctured by panic attacks and he dropped out of college. He pushed friends and family away and got into an unhealthy romantic relationship. He was charged with assault and attempted suicide. Therapy and medication did not help.
But after attending the trial, he no longer has nightmares. “I’m literally a different person,” he said.
During his first of three sessions in early 2019, lying on a sofa with eye shadows and in a clear dreamlike state, Ostrom encountered a spinning, greasy black ball. Like an onion, the sphere had many layers, each a memory. At the center, Ostrom revived the moment in Iraq, he said, “I became the person I had to be to survive that rollout.” Over the next two sessions, Ostrom dealt with the “bully” as he calls his PTSD alter ego and asked permission for Scott to return.
Ostrom, 36, now works steadily as an HVAC specialist and owns a home near Boulder, Colorado, which he shares with his girlfriend, Jamie Ehrenkranz, and his service dog, an English lab named Tim.
“The reason I like to call this medicine is that it stimulated my own consciousness’ ability to self-heal,” Ostrom said. “You understand why it’s OK to experience unconditional love for yourself.”
Merck pharmacists invented MDMA, an abbreviation for 3,4-methylenedioxy-N-methylamphetamine, in 1912. But the compound was largely forgotten until 1976, when Alexander Shulgin, a well-known psychedelic chemist, synthesized MDMA and tried it himself. When he discovered that his discovery could have therapeutic value, Shulgin shared MDMA in 1977 with Leo Zeff, a psychotherapist who introduced it to other mental health professionals. Over the next eight years, hundreds of therapists and others administered an estimated half a million doses of MDMA. Some reported that in a few sessions with the medication, the patients achieved an improvement that usually took years.
In the early 1980s, however, MDMA fled from the clinic to the dance floor, where it became known as ecstasy. In 1985, the Drug Enforcement Administration criminalized MDMA as a Form I drug, defined as “nothing currently accepted for medical use and a high potential for abuse.”
Some mental health professionals continued to administer MDMA-assisted therapy underground, but most stopped. The number of researchers pursuing studies with MDMA also declined. But a few individuals continued to push hard on behalf of MDMA research, including Doblin, who founded his association in 1986 to focus on developing MDMA and other psychedelics for FDA-approved drugs. It took nearly two decades to overcome alarmist claims about the dangers of ecstasy, including eating holes in users’ brains to finally get approval to start studies. Animal and human research confirms that MDMA does not produce any neurotoxic effects at doses administered in clinical trials.
Ecstasy or molly, on the other hand, can be counterfeited with other potentially dangerous substances, and users can take much higher doses than is safe. In 2011, MDMA accounted for 1.8% of all U.S. drug-related emergency visits, according to a database maintained until that year of substance abuse and mental health administration. In Europe, MDMA was responsible for 8% of drug-related emergency visits to 16 major hospitals in 10 countries from 2013 to 2014.
Researchers still do not fully understand the source of MDMA’s therapeutic effects. The substance binds to proteins that regulate serotonin, a neurotransmitter that can, among other things, lift the mood. Antidepressants like Prozac bind to the same proteins and block their reabsorption of serotonin, but MDMA takes this process further and causes the proteins to pump serotonin into synapses and strengthen their chemical signal.
MDMA also raises levels of oxytocin, dopamine and other chemical messengers, giving feelings of empathy, confidence and compassion.
But its primary therapeutic effect may come from its apparent ability to reopen what neuroscientists refer to as a “critical period,” the window of childhood when the brain has the superior ability to create new memories and store them. Evidence from a mouse study published in Nature in 2019 indicates that MDMA may return the adult brain to this earlier state of malleability.
An estimated 7% of the U.S. population will experience PTSD at some point in their lives, and as many as 13% of combat veterans have the condition. In 2018, the U.S. Department of Veterans Affairs spent $ 17 billion on disability payments for more than 1 million veterans with PTSD.
For about half to a third of people who do not find relief through treatment, PTSD can become chronic lasting years or even a lifetime.
The 90 participants who participated in the Phase 3 trial included combat veterans, first responders, and victims of sexual assault, mass shootings, domestic violence, or trauma from children. All had severe PTSD and were on average diagnosed for more than 14 years. Many had a history of alcohol and drug abuse, and 90% had considered suicide. The trial included data collected by 80 therapists at 15 sites in the United States, Canada and Israel.
Albert Garcia-Romeu, a psychopharmacologist at Johns Hopkins University School of Medicine who was not involved in the study, said further research is needed to investigate the effectiveness of the therapy for people of different races and ethnicities because three-quarters of the trial the participants were white. This limitation also underscores, he said, “the importance of the availability of these types of treatments for people of color and people with lower socioeconomic status who already suffer from health inequalities and high levels of trauma.”
But overall, Garcia-Romeu said, the findings “make it clear for medical approval,” something that “represents a sea change that could revolutionize health care.”
Nathan McGee, 43, is another example of a patient who has benefited from the drug. Since he was a teenager, he has been in and out of therapy and on and off medication for depression and anxiety.
“I was always angry for no reason,” he said. In 2019, McGee was diagnosed with PTSD as a result of an event that happened when he was 4 years old.
As a trial participant, he first thought he had received placebo. But about an hour into his first session at a Boulder campus, a calm consciousness slipped over him and he felt himself moving inward.
Under the influence of MDMA and guided by his therapists, McGee was able to revise his traumatic memory through the eyes of his 4-year-old self, unheard of by stigmas, adult interpretations, or heavy emotions.
“This allowed me to accept myself and recognize who I am,” he said.
Since attending the trial in early 2020, he is less angry and more able to enjoy the moment.
“I’m constantly discovering new things and improving,” McGee said. “It made me really understand what the feeling of joy is.”
This article originally appeared in The New York Times.
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