- A second large phase 3 clinical trial found that the psychedelic MDMA, alongside psychotherapy, is an effective treatment for post-traumatic stress disorder (PTSD)
- MDMA is currently illegal in all countries except Australia, which recently approved it as a treatment for certain mental health conditions.
- The sponsor of the new study will ask the Food and Drug Administration to approve MDMA-assisted therapy as a treatment for PTSD.
The psychedelic drug MDMA, commonly known as “ecstasy” or “molly,” has moved one step closer to receiving approval from the Food and Drug Administration as a treatment for post-traumatic stress disorder (PTSD).
This comes after a second large phase 3
“A lot of the patient population that we work with have tried everything else or have been struggling with ineffective [PTSD] treatments for a long time,” said Brett Waters, co-founder and executive director of Reason for Hope, a group that advocates on behalf of veterans and others on issues related to psychedelic medicine and assisted therapies.
“So this development is very exciting, and hopefully will lead to a significant new treatment option for people who really need it,” he told Healthline.
In the new study, sponsored by nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), 104 people with moderate or severe PTSD received MDMA-assisted therapy — using a protocol developed by MAPS — or an inactive placebo with therapy.
After three 8-hour treatment sessions spaced approximately 1 month apart, 71% of people in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD, compared to 48% of those in the placebo with therapy group.
The results of the clinical trial were published September 14 in
MDMA-assisted therapy seemed to work equally well regardless of the severity of a person’s PTSD, and in people at risk of alcohol or substance use disorder, or with a history of childhood trauma.
It also worked just as well across racial and ethnic groups. One-third of participants identified their race as “other than white,” and over one-fourth identified their ethnicity as Hispanic/Latino.
People from racial and ethnic minorities and other diverse groups are
Nehal Vadhan, PhD, a clinical psychologist at Northwell Health’s Zucker Hillside Hospital, said one of the strengths of the study is its greater diversity.
“This study did a much better job of being able to recruit individuals from non-white populations, while still demonstrating a powerful effect,” he told Healthline. “So that’s a great leap forward for this field.”
The results of the new study were similar to an earlier
In that study, after three 8-hour treatment sessions spaced around 4 weeks apart, 67% of those who received MDMA-assisted therapy no longer qualified for a PTSD diagnosis, compared to 32% of those who received placebo with therapy.
For people with PTSD who benefit from this treatment, MDMA potentially enhances psychotherapy by “reducing sensations of fear, threat and negative [emotions],” the authors write.
However, while the results of these two trials are promising, Vadhan cautions that MDMA-assisted therapy may not work for everyone.
“Many people are not willing to take psychedelics, for whatever reason,” he said. “And there are people, as you can see from the study results, who have negative side effects from taking such a powerful drug.”
The most common adverse events experienced by participants in the new study who took MDMA included muscle tightness, nausea, decreased appetite and excessive sweating. Most cases were mild or moderate and went away on their own.
Although none of the participants who took MDMA had a severe reaction, Vadhan said a minority of people who use a psychedelic have lasting negative outcomes, such as after a “bad trip.”
So for people who can’t or don’t want to undergo psychedelic-assisted therapy, “we need to improve existing treatments to accommodate those people,” he said.
One of the promising aspects of the new study is that only 2% of people in the MDMA-assisted therapy group dropped out of the trial early. In the placebo with therapy group, 16% dropped out, which the researchers said may be due to them receiving “less effective treatment.”
In contrast, a 2022
“I think that there will be a large demand for this treatment, if it is approved,” said Waters, “particularly among the veteran population, including those who haven’t been helped by gold-standard therapies such as SSRIs [selective serotonin reuptake inhibitors] and other medications.”
MAPS and other groups have been advocating for the legalization of MDMA, which is a Schedule I drug in the United States, a federal designation for substances with high potential for misuse and no currently accepted medical use.
MDMA is also illegal in most other countries. However, in July of this year, Australia became the first country to allow psychiatrists to prescribe MDMA for the treatment of certain mental health conditions.
MAPS plans to seek formal approval from the FDA later this year. Because the agency has designated MDMA as a “breakthrough therapy” — a category for potentially promising treatments for serious or life-threatening conditions — the application should be evaluated quickly.
If MDMA is approved by the FDA as a treatment for PTSD, the Secretary of Health and Human Services (HHS) would recommend the drug be rescheduled to a less restrictive tier. After that, the Drug Enforcement Agency would release an interim rule for the rescheduling of the drug.
While MDMA would still have restrictions — how many would depend upon the final scheduling — it would no longer be strictly illegal.
LtGen. Martin R. Steele, a retired three-star General in the United States Marine Corps and co-founder of Reason for Hope, said even after FDA approval, there would still be a lot of work to do to ensure that people, especially veterans, can access and afford this treatment.
“We need to train more providers using veteran-focused protocols, both inside and outside the Veterans Administration,” he told Healthline. In addition, treatment options such as community-based care and group therapy, and robust coverage by health insurance will be needed, he added.
“What we don’t want to happen after this success is for only a minority of people to be able to afford the treatment,” said Steele.
Dr. Rick Strassman, author of The Psychedelic Handbook and clinical associate professor of psychiatry at the University of New Mexico School of Medicine, said the Schedule I status of MDMA is the main roadblock to wider availability of this drug as a treatment.
Schedule I status also makes it harder for researchers to study MDMA as a treatment for various conditions, because they have to go through many levels of approval in order give the drug to study participants.
FDA approval and rescheduling of MDMA would allow researchers to more easily pursue larger clinical trials of the drug, including to examine why some people don’t respond to MDMA, whether certain types of therapy work better with the drug, and how long the effects last.
“In order to really know what the long-term effects [of a treatment] are, often that requires FDA approval,” said Vadhan, “which allows doctors to be able to administer the drug clinically.”
While the new study focused on the use of MDMA-assisted therapy for PTSD, Strassman said the results may support research on other psychedelics.
“This does have rub-off effects on other psychedelic research,” he told Healthline. “That is, psychedelics given under strict clinical research conditions can be helpful.”
However, “each condition and each medication has to be studied independently,” emphasized Vadhan. “One shouldn’t assume that you would see the same results, for example, with psilocybin.”
In a large phase 3 clinical trial, researchers found that MDMA-assisted therapy improved symptoms in more than two-thirds of people with moderate to severe PTSD.
The sponsor of this racially-diverse study will submit an application to the FDA for approval of MDMA-assisted therapy for PTSD.
Patient advocates say more work is needed to ensure that this treatment is widely available and affordable to those in need, including veterans, who may not benefit from existing treatments for PTSD.
Source link : https://www.healthline.com/health-news/will-the-fda-approve-psychedelic-mdma-to-treat-ptsd-what-to-know
Publish date : 2023-09-21 18:56:09
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