In recent years there’s been a surge in research on the use of psychedelic drugs, like psilocin, esketamine, and mescaline, to treat psychiatric disorders.
In this case, MDMA would be used in conjunction with long therapy sessions to help the patient connect with the therapist and the work being done.
“MDMA is really interesting because it’s an empathogen,” said team leader, Dr. Jennifer Mitchell, a neurologist at the University of California at San Francisco (UCSF), said 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.”
Previous studies have shown MDMA can help “reconsolidate,” or process, fear memories in an area of the brain called the amygdala. Its growing popularity as a street drug since the 1980s has caused overdoses and deaths, prompting the Food and Drug Administration (FDA) to make MDMA illegal in the United States in 1985.
But under controlled circumstances, there’s growing evidence MDMA can be a powerful tool in helping people with long-term trauma. Mitchell’s team focused on treating PTSD, a debilitating condition characterized by amnesia, flashbacks, and nightmares related to a traumatic event.
People with PTSD experience depression, anxiety, substance use disorders, and suicide. Current therapeutics are only effective in about half of patients, Mitchell says. And many people with PTSD either fail to respond or quit going to psychotherapy sessions.
“The aspect of this work that is most intriguing is that the study is exploring how psychological and drug therapies can work together to be truly synergistic,” Dr. Nick Allen, the co-founder of Ksana Health and director of the University of Oregon’s Center for Digital Mental Health, told Healthline.
“It’s not just a matter of adding the effects together, but the drug may actually help the psychological therapy to work more effectively by helping the person to be able to learn more from their psychotherapy experience,” Allen told Healthline.
“This may be because of the way MDMA can expand people’s capacity to experience empathy, which is a key component of many psychological therapies. So, both aspects are likely to be necessary components.”
Mitchell’s team enrolled 90 people with severe PTSD in the first phase 3, randomized, double-blind, placebo-controlled study of MDMA-assisted therapy for the treatment of this disorder. Participants attended an 8-hour therapy session after a half dose. This process was repeated twice, a month apart each time, in addition to weekly therapy.
Two months after the final session, about two-thirds of the subjects no longer met the diagnostic criteria for PTSD, compared with one-third of those who received placebo plus therapy. Side effects, which included jaw clenching and nausea, were minimal. Researchers say there were no signs of addiction.
Regardless, MDMA won’t be something patients can pick up at a pharmacy and take home, Dr. Carlene Macmillian, the medical director at psychedelic-assisted therapy provider Osmind and co-founder of Brooklyn Minds Psychiatry, told Healthline.
“When MDMA gets FDA approval for treating PTSD, it will be quite unique amongst FDA approvals in that it will also specify on the label that psychotherapy be included in the labeling,” Macmillan told Healthline.
“Just as esketamine has a risk evaluation and mitigation program [REMS], we anticipate MDMA will as well, and that part of this REMS will entail clinicians documenting that therapy was provided during the multi-hour sessions.”
Macmillan also said that the structure of the therapy may vary for different drugs but that therapists will have to adhere to guidelines followed in similar trials.
“This also includes integration and preparation sessions prior to the sessions that involve administration of the MDMA,”Macmillan said.
“Esketamine, which was FDA approved in 2019, has a REMS program that also specifies that it must be administered in a clinic setting that is registered with the program. We anticipate the same will be true of MDMA.”
Dr. Paul Poulakos, a board certified psychiatrist in Greenwich Village, New York, told Healthline that the effectiveness of MDMA depends on a patient-therapist bond it helps develop.
“Although research regarding MDMA-assisted psychotherapy is limited, the psychotherapy component is an essential part of the treatment,” Poulakos said. “MDMA typically increases empathy, encourages introspective thought, and allows for an increased closeness between patient and therapist.
“The idea is that MDMA positively influences the dynamics between therapist and patient and thereby enhances the efficacy of psychotherapy,” Poulakos continued. “Rather than being a replacement to psychotherapy, MDMA is a potential tool that has the potential to improve the efficacy of psychotherapy and potentially allow for a quicker recovery.”
Poulakos said that there would need to be more studies comparing the outcomes of groups who have received MDMA in conjunction with psychotherapy compared to those who received MDMA alone to figure out assess whether there’s a benefit from MDMA when it’s administered without of psychotherapy.
Opinions vary as to whether the acceptance of MDMA as a legitimate therapeutic to treat conditions like PTSD, anxiety, drug and alcohol disorders, or other psychological problems would increase its street availability.
“Not necessarily,” Dr. James Giordano, a professor of neurology ad biochemistry at Georgetown University Medical Center in Washington, D.C. “MDMA that is used in clinical protocols (to treat PTSD, depression, etc.) would be directly administered by a clinician, in a clinical (office or hospital) setting.
“The drug would not be directly provided to the patient, and therefore the possibility for distribution of MDMA outside of the clinical environment is low, if not nil, due to the ‘gatekeeping’ effect of clinician administration,” Giordano told Healthline.
“At present, MDMA that is available for investigational purposes is provided by FDA and DEA approved chemical manufacturing commercial entities, Giordano said.
“Given the increased interest in, consideration of, and viable and valuable use for MDMA in therapeutic interventions for PTSD, and other neuropsychiatric conditions, there have been increased calls for more standardized good manufacturing processes (GMP) and in this light, such processes and protocols have been proposed.
“Any and all such manufacturing would be fully regulated by the Food and Drug Administration in the United States, and comparable agencies internationally.”
The UCSF team is currently enrolling participants for a second phase 3 trial, and if all goes well, they anticipate that MDMA-assisted therapy for PTSD could be approved by the FDA as early as 2023.