The results of a phase 3, randomized, double-blind, placebo-controlled study of MDMA-assisted therapy suggest the drug, when combined with therapy, can be an effective treatment for Post Traumatic Stress Disorder as well as drug and alcohol use disorders, researchers say.
Jennifer Mitchell, a neurology professor at the University of California, San Francisco and principal investigator on the study presented the findings on Tuesday at the American Chemical Society’s spring meeting.
“MDMA is effective in allowing people to revisit previous trauma in a way that does not immediately initiate their detachment or their withdrawal. And I think that that's really hard to do otherwise”, Mitchell said in a media briefing.
What you need to know first— An estimated six percent of people in the United States will experience PTSD at some point in their life, and those numbers have likely increased over the past two years. PTSD is a challenging disorder to treat, especially because people who have it are at a higher likelihood of developing other disorders, like substance use disorders.
Following in the footsteps of previous research looking at the use of MDMA combined with psychotherapy, Mitchell and colleagues wanted to evaluate if MDMA could increase the effectiveness of psychotherapy for patients with PTSD.
“MDMA is really interesting because it’s an empathogen,” said Mitchell in a statement. “It causes the release of oxytocin in the brain, which creates feelings of trust and closeness that can really help in a therapeutic setting.”
Animal studies have shown that MDMA can help process traumatic memories in the amygdala, an area of the brain that controls stress response and is associated with memory.
What the researchers did— For the phase 2 trial, the researchers wanted to determine the best dose of MDMA, ultimately concluding a full dose, followed by a half dose an hour later, was optimal.
In this first part of phase 3, 90 participants with severe PTSD received the full and a half dose an hour later. In contrast to phase 2, however, the 90 participants in phase three attended an eight-hour therapy session after taking the half dose.
A month later, the process was repeated. In addition, the participants attended weekly therapy.
Participants were spread out across “15 study sites located across North America and two study sites in Israel as well,” Mitchell said in the ACS briefing. “All of the study sites contributed phase three data.”
The placebo group received a placebo and the same amount of therapy.
Two months following the last treatment session, the researchers assessed the participants' PTSD symptomology.
What they found— A whopping two-thirds of people in the MDMA group no longer met the criteria for PTSD two months after their last treatment.
“The subjects that received MDMA plus therapy fared significantly better. They improved significantly more than subjects that received placebo plus therapy,” Mitchell explained in the briefing.
Mitchell believes that MDMA allows people to relive a traumatic experience without dissociating or having other reactions that might hinder psychotherapy.
“You can imagine if people are reliving an experience that was stressful and fear-provoking, in essence traumatizing. It’s not simple in a therapeutic setting. So MDMA allows them to recall the original experience without guilt or shame,” Mitchell said.
What’s next— What’s still unknown is precisely how long the PTSD relief will last.
“Based on the findings from the phase two studies, it appears that MDMA is a particularly long-lasting therapeutic,” Mitchell said. “In those studies, they followed the subject population out for in some cases 18 months and they found that the effects continued to last and in some cases, even improved over time. So that was really interesting. And hopefully, in another year, we'll know for phase three.”
For now, the researchers are trying to replicate their results. “The pivotal trials are completed and published, and now we're in the replication phase,” she said. “The FDA has asked for at least another 100 subjects, and once those data are wrapped up, then the sponsor can take a look at the data and determine whether they have enough there to actually go ahead and submit that new drug application.”
If all goes well, MDMA therapy could be available to the public by the end of 2023, Mitchell said.
