Summary: Tonic reports on the progress of MAPS’ Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD, highlighting an upcoming meeting with the FDA to design Phase 3 clinical trials.
Originally appearing here.
Marcela Ot’alora thought she had tried everything. For most of her life, she had been living with post-traumatic stress disorder—a condition she describes as “trapping people in their memories.” Then, in 1984, at the age of 23, she took MDMA for the first time.
“It saved my life,” Ot’alora says. “That’s when I began to say this needs to be available for people.”
That same year, the Drug Enforcement Agency published a notice that they were planning to classify MDMA—a drug that acts as both a stimulant and psychedelic, and is a component of the party drug Ecstasy—as a Schedule I substance with no medical use due to its neurotoxicity and potential for abuse.
Psychotherapists who had been using MDMA to treat neuroses, relationship problems, and post-traumatic stress disorder since the early 1970s opposed the scheduling, speaking at hearings about their positive clinical experiences. Their challenge failed: In 1985, amid headlines of the drug’s escalating recreational use, the DEA announced an emergency Schedule I classification.
Ot’alora, who was working as an installation artist at the time, went back to school for a Master’s degree in mental health counseling with a newfound purpose—to help get MDMA-assisted psychotherapy legalized. Thirty-two years later, she’s still fighting—and now has reason to feel optimistic.
For the past 15 years, Ot’alora has worked with MAPS, the Multidisciplinary Association for Psychedelic Studies. The Santa-Cruz–based nonprofit recently announced an ambitious $20 million plan to make MDMA-assisted psychotherapy more widely available by 2021. So far, everything appears to be on track.
Depending on the results of their research, that could be encouraging news for the more than 7 million people afflicted with PTSD in the US alone. Earlier this year, Ot’alora and her fellow investigators—a team comprised of distinguished professors and psychotherapists—bought $400,000 of pure MDMA from a pharmaceutical company, which can legally sell the drug in the United States to researchers who have received approval from the FDA.
In January, MAPS will recruit hundreds of patients to begin four years of studies on MDMA-assisted psychotherapy. Donors have already pledged more than half of the $20 million needed for this round of trials, and Maps is meeting with the FDA on November 29 to get the design of their Phase III studies approved—an optional move that helps new drugs reach the market faster if they’re proven safe and effective.
Each treatment plan would involve 15 talk therapy sessions—two of which are eight hours long and conducted while the patient is under the influence of MDMA. In those sessions, patients would wear an eye cover and listen to music while the drug’s effects kick in. “We encourage them to focus and process what comes up,” Ot’alora says.
Ot’alora hopes this altered state of mind will allow patients to more effectively explore suppressed emotions, which experts agree is a critical step toward acceptance of trauma.
So far, this method of treatment has posed minimal risks. Since it was made illegal, MDMA has been administered to 1,133 people for research purposes without any serious adverse effects, according to a recent study. (Until now, the scale of MAPS studies has been a major barrier to gaining traction within the scientific community.) Earlier this year, it was tested for the first time to treat social anxiety in adults with autism. And in MAPS’ first MDMA-assisted psychotherapy study, a small-scale pilot completed in 2011, 83 percent of participants showed no symptoms of post-traumatic stress disorder four years after treatment. More research is also underway: In June, the DEA approved MAPS’ protocol for the first study administering MDMA to couples in which one partner has PTSD.
“I think there is more interest [from the federal government in MDMA] now because we’re simply out of options for treating psychiatric disease, particularly PTSD,” says Boris Heifets, a Stanford University neuroanesthesiology fellow.
Heifets has studied how MDMA works on a physiological level. “We know almost nothing about what parts of the brain mediate its effect,” he says. Last year, an Emory University study found that mice became less fearful when MDMA was injected directly into their amygdalas, an area of the brain that controls fear response.
For now, the only broadly accepted fact about the way MDMA works is that it releases serotonin and dopamine—chemicals associated with reward, but which actually affect many different behavioral processes. “That doesn’t mean too much—Coca Cola and Prozac both release those neurochemicals, too,” Heifets says.
Still, PTSD therapists unaffiliated with the MAPS research, including two at the US Department of Veterans Affairs, say the MDMA-assisted psychotherapy trials are promising. “We’re waiting excitedly,” says Dorene Loew, a VA psychologist in Menlo Park, California. “If our [PTSD] treatment can be advanced, we would incorporate it.”
Innovation is long overdue. The last significant release of new PTSD medications—antidepressants called SSRIs—was in the 1990s. Since then, they’ve only proven effective 20 to 30 percent of the time, says Franklin Schneier, a psychiatrist who has conducted clinical trials on PTSD medications. Some research has found that Prazosin quells nightmares, a common symptom of PTSD. Propranolol has also shown some success in blocking the development of PTSD, but only when administered directly after a traumatic incident.
The gold standard for treatment continues to be “prolonged exposure,” which involves patients repeating their memories with the help of a therapist. Brain scans show this process can decrease the volume of the rostral anterior cingulate cortex (rACC), which is associated with fear in patients. It’s effective more than half the time, says Yuval Neria, director of Columbia University Medical Center’s Trauma and PTSD Program. But more than 20 percent of participants drop out because discussing their trauma openly is too grueling.
“If you had this awful experience, then it can be rough to sit and talk about it in detail,” says Marcel Bonn-Miller, a professor of psychology at the University of Pennsylvania.
“This is why people continue to look for new treatments. We just don’t have it solved yet.”