MDMA-assisted therapy is thought to be effective for conditions such as: Reduce symptoms of post-traumatic stress disorderAccording to study results released Thursday.
This study is the last trial conducted by MAPS Public Benefit Corporation, a company that develops prescription psychedelic drugs. The company plans to submit its findings to the Food and Drug Administration as part of its application for approval to market the psychedelic drug MDMA as a treatment for PTSD in combination with talk therapy.
If approved, “MDMA-assisted therapy would be the first new treatment for PTSD in more than 20 years,” said the company’s chief scientific officer and lead author of the study published in Nature Medicine. said one Bela Yazar Krosinski. . “PTSD sufferers can feel hope.”
Each year, approximately 5 percent of the U.S. adult population suffers from PTSD. But conventional treatments and medications can only help about 50% of patients at best, said Dr. Stephen Xenakis, a psychiatrist and executive director of the American Association of Psychedelic Physicians who was not involved in the study.
“In my clinical experience, too many men and women have lost hope with conventional treatments and treatments and feel that suicide is their only ‘way out’,” Dr. Xenakis said. “We need to do more to help them. MDMA-assisted therapy offers a new option that, if done thoughtfully and professionally, can potentially save lives.”
MDMA, also known as ecstasy or Molly, has been an illegal drug since 1985, when the Drug Enforcement Administration classified it as a Schedule 1 drug, the highest category of controlled substances the agency deems to have no medical use. Masu. There is a high possibility of abuse.
Before that, MDMA was administered by an estimated hundreds of therapists in North America and Europe for the purposes of couples counseling, personal growth, and dealing with trauma.
“The great tragedy that needs to be pointed out is that in the late 1970s and early 1980s, it was clear that MDMA had incredible therapeutic properties,” said the nonprofit organization Psychedelics, which owns MAPS. said Rick Doblin, founder of the Multidisciplinary Association for Research (MAPS). PBC. “The suffering since then due to the criminalization of MDMA has been immeasurable.”
MAPS has advocated for the legalization of MDMA-assisted therapy since 1986 and supported research into its use in the treatment of PTSD since 2001. Another nonprofit, the Hefter Institute, is conducting similar research on psilocybin, the active ingredient in magic mushrooms. Since 1993.
In 2017, the FDA granted “breakthrough therapy” status to MDMA-assisted therapy as a treatment for PTSD. This designation allows for the rapid development of promising experimental drugs. Psilocybin-assisted therapy for treatment-resistant depression achieved breakthrough status in 2018.
The 104 participants in the new study were diagnosed with moderate to severe PTSD and had been living with the condition for an average of 16 years. These included victims of childhood trauma, military veterans, and survivors of sexual assault. Many had a history of suicidal ideation and also suffered from comorbidities such as depression and alcohol use disorder.
Each participant worked with a two-person treatment team and received three 90-minute preparatory talk therapy sessions, followed by three treatment cycles 1 month apart. Each session consisted of an 8-hour experimental session in which participants took either MDMA or a placebo in combination with talk therapy, followed by three 90-minute talk therapy sessions. I participated.
During the experimental session, 53 participants were given MDMA and 51 were given an inert placebo. Neither the therapist nor the participants were informed which patient received her MDMA.
According to the research paper, participants in the group given MDMA experienced a significant reduction in PTSD symptoms compared to participants in the group given a placebo.
By the end of the study, 86.5 percent of the MDMA group achieved a measurable reduction in symptom severity, the researchers reported. Approximately 71 percent of the MDMA group improved to the point that they no longer met diagnostic criteria for PTSD. Among those who took the placebo, 69% experienced improvement in symptoms and nearly 48% no longer qualified for a PTSD diagnosis.
The findings were similar to the following: First phase 3 trial Research results on MDMA-assisted therapy for PTSD published in Nature Medicine in 2021. Of the 90 participants in the study, 67% of the MDMA group no longer qualified for a PTSD diagnosis after two months of treatment, compared with 32% of the placebo group. .
Jennifer Mitchell, a neuroscientist at the University of California, San Francisco and lead author of both studies, said one notable difference in the latest studies was the diversity of participants.
More than a quarter of participants in the new study were Hispanic or Latino and about 34 percent were non-white, compared to about 9 percent of participants in the 2021 study were Hispanic or Latino and 22 percent were non-white. were non-white.
“We worked long and hard to get a study population that was more consistent with the general population with PTSD,” Dr. Mitchell said. “This is not just privileged people with a lot of time and resources.”
The increase in participant diversity coincides with an increase in the number of therapists of color, up from 11 percent in 2021 to 28 percent in the new study. MAPS PBC also said it provided participants with transportation to and from the study site and research expenses. This may be to replace lost wages or cover childcare or nursing care.
Albert García Lomu, a psychopharmacologist at Johns Hopkins University School of Medicine who was not involved in the study, said the diversity of participants was “definitely an improvement over previous studies.” But he added: “It will be important that more Black and Indigenous people register, given the significant health disparities these groups face.”
Similar to previous studies of MDMA adjuvant therapy, data presented regarding adverse events indicated that the treatment was generally well tolerated. Common side effects, mostly in patients in the MDMA group, included muscle tension, nausea, decreased appetite, and sweating.
Two participants in the MDMA group and one participant in the placebo group experienced severe suicidal thoughts during the study, but no suicide attempts were reported.
“Although people in both groups experienced similar rates of alarming adverse events such as suicidality, it is notable that most of the study participants were already struggling with these challenges beforehand. You deserve it,” said Dr. García Lomu.
Seven participants overall also experienced cardiovascular problems, such as increased heart rate. Dr. Paul Summergrad, a professor of psychiatry at Tufts University School of Medicine who was not involved in the study, said the events were “generally not serious,” but that cardiologists should evaluate older patients or those with heart problems. This may indicate that there is a need to do so. Problems before treatment with MDMA.
MAPS PBC said it worked closely with the FDA to determine the study methods and number of participants needed to evaluate the safety and effectiveness of the new treatment.
Most participants correctly guessed whether they were given a placebo or MDMA. This is a typical challenge across psychiatric research, which the authors acknowledge, and which they have done everything possible to alleviate. said Dr. Steven Zalcman, Director of Development. I am involved in research.
Researchers are currently working on a follow-up study to examine the long-term durability of the effects of MDMA-assisted therapy. The results of the MAPS-sponsored phase 2 study show that Benefits continued for at least 12 months For most participants who received the drug.
MAPS PBC plans to submit a new drug application to the FDA seeking approval for MDMA-assisted therapy. The agency does not comment on pending drug reviews, but a decision could be made within a year.
Some outside experts said they did not believe the study results would meet FDA approval standards.
“The effect of the active drug group was not significantly greater than the effect of the placebo group,” said Dr. Allen Francis, professor emeritus of psychiatry at Duke University. “MDMA therapy adds enormous costs to the treatment system while providing only modest specific benefits, resulting in a massive misallocation of already extremely scarce resources.”
However, Dr. Acqua Prieto Brown, medical director of Alchemy Community Therapy Center in Oakland, California, who was not involved in the study, also criticized this “deficiency mentality” and said that medical professionals should focus on said it should. Instead, it focuses on “increasing treatment options for conditions that are notoriously difficult to treat.”
Dr. Xenakis said that disagreements among mental health professionals are to be expected. It’s sexual,” he added.
If MDMA-assisted therapy were approved by the federal government, it would also mean that the drug would have to be ranked as a less serious controlled substance by the DEA and the state.
Therapist training is also a potential bottleneck. The company already oversees its own therapist education program and is working with other partners, including universities, to enhance training.
Amy Emerson, chief executive officer of MAPS PBC, said it remains unclear what specific standards and requirements the FDA will require of prescribers and how the FDA will outline labeling instructions for MDMA-assisted therapies. said that it was a problem.
“Drug-assisted therapy has never been approved and there is not much precedent,” she says.
Emerson said the company has not yet set a price for the drug and has no control over how much the therapeutic ingredients will cost.
But Emerson said he is in contact with insurance companies, Medicaid and Medicare to try to secure coverage. The group also works on patient access programs to help people who are uninsured and unable to pay out of pocket receive discounted or free care.
Given the hurdles still ahead, “I feel like it’s a little too early to really celebrate,” Dr. Doblin says. “But it’s been a long, long process, and it’s amazing how far we’ve come.”
