An organization that&#x2019;s been conducting clinical trials on MDMA therapy has filed a new drug application with the Food and Drug Administration that would make the drug legal for treating post-traumatic stress disorder if approved.

The Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a company that promotes the regulation of psychedelics, [said Tuesday](https://www.prnewswire.com/news-releases/maps-pbc-announces-submission-of-new-drug-application-to-the-fda-for-mdma-assisted-therapy-for-ptsd-302011980.html) it filed the application for MDMA capsules which would be used in conjunction with psychotherapy or talk therapy and other supportive services.

If approved by the FDA, MDMA would be rescheduled by the Drug Enforcement Agency so that it could be prescribed. MDMA is currently a Schedule I drug under the Controlled Substances Act, meaning the government believes &#x201c;it has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.&#x201d;

"The filing of our (new drug application) is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades," said Amy Emerson, chief executive officer of MAPS PBC, in the announcement.

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The FDA has 60 days to decide if it will review the application and whether it will be a  priority or a standard review, which take six and 10 months, respectively.

MAPS PBC completed two Phase-3 clinical trials on MDMA therapy. Results from the first Phase 3 study, published in [Nature](https://www.nature.com/articles/s41591-021-01336-3), showed 88 percent of participants with severe PTSD experienced &#x201c;a clinically significant reduction in PTSD diagnostic scores&#x201d; after three sessions compared to 60 percent of placebo participants. Of 1,700 participants who were given MDMA, only one had an adverse reaction, according to MAPS PBC.

A decidedly stock photo of a couple who are probably not doing ketamine therapy.

The first time Isabel and her husband did MDMA together, they were at Burning Man, just a couple of weeks before their wedding. It was a profound experience.  “It was like being seen for the first time for who we really were because it allows you to be super vulnerable and allows you to share these deep parts of yourself without fear of being judged,” said Isabel.  “I felt like we got married out there.”  She and her husband Joseph, both physicians in their 40s who live in British Columbia, have been together for 15 years. VICE News has changed their names to protect their privacy because MDMA is illegal. They don’t use drugs often—the Burning Man trip, 11 years ago, was Joseph’s first time taking MDMA. These days their trips look pretty different from a festival. Once a year, they get a babysitter for their two kids, rent a room at a resort and take the psychedelic to work through conflicts in their relationships.  “We wind up spending a night and just pushing through about six months worth of marriage crap all at once,” Joseph said. “You're just kind of a different couple on the other side of it. It’s very interesting.”  Because of Isabel’s training in using both ketamine and MDMA for therapeutic reasons, the couple generally trips on their own while going through their issues. But they’ve also had a guided trip with an underground therapist who serves people under the influence of psychedelics. They’re part of a growing number of couples who are adding psychedelics to their couples’ therapy experiences. <div style="max-width:660px" data-iframely-id="zGZyPkZ" data-embedded-url="https://www.instagram.com/p/CupKf_cMEJr/?img_index=1" class="article__embed article__embed--instagram article__embed--iframely"><div style="left:0;width:100%;height:0;position:relative;padding-bottom:63%;padding-top:284px" data-iframely-smart-iframe="true"><iframe src="https://oembed.vice.com/zGZyPkZ?v=1&lazy=1&app=1&img=1&playerjs=1" style="top:0;left:0;width:100%;height:100%;position:absolute;border:0" allowfullscreen data-iframely-smart-iframe="true" frameborder="0"></iframe></div></div> Psychedelics are having a renaissance, with substances like ketamine, psilocybin (the active ingredient in magic mushrooms), and MDMA being studied and used to treat issues like depression, post-traumatic stress disorder, drug addiction, and end-of-life anxiety. While MDMA remains illegal in the U.S. and Canada, last year the nonprofit group Multidisciplinary Association for Psychedelic Studies (MAPS) completed a second phase-three trial on using the drug as PTSD treatment and is expecting the Food and Drug Administration to evaluate its findings in 2023, potentially approving it for people with the disorder. In the meantime, MAPS and other groups already offer training in psychedelic-assisted therapy, while some therapists are already adding ketamine to their services because it’s legal. Others are offering discreet therapy sessions using illegal drugs. And both underground and above ground practitioners told VICE News demand is growing among couples who think psychedelics could help them take on their issues.  “I tell my couples, ‘Look, this is not a magic pill. It's an assist.’ And I would say that if they're willing to do the work, it expedites forgiveness,” said Jayne Gumpel, a Woodstock, New York-based clinical social worker who has treated around 150 couples using ketamine.  Some of them have recommitted to each other after being on the brink of divorce, she said.  Gumpel also offers group retreats for couples; private sessions run for $200 an hour, while four-day retreats are $1,850 a person on a sliding scale. She said people often choose partners who provoke their defences or trigger trauma for their childhood, but they don’t necessarily realize it. While using ketamine, she said people’s defences are lowered and they’re less attached to the idea that their side of the story is correct.  <div class="article__embed article__embed--vice" data-related-article="true" data-children-count="0"><iframe src="https://www.vice.com/en_us/embed/article/n7eea8/embed" frameborder="0" style="border:0px none;margin:0px" allowfullscreen></iframe></div> “When the person who's listening learns how to hold that space and not get reactive…what happens is the person who's sharing their frustration about messiness starts to talk about their childhood when their mother was alcoholic and the house was a mess and they took it upon themselves to have to be the one to keep things organized. And that's how she felt safe,” Gumpel explained. “All of a sudden, the partner who feels ragged on because he's sloppy has empathy for the person who's complaining to him about it. “It’s like a magical moment when they’re now understanding they have consciousness of this pattern they’re stuck in,” she added.  Recently, Isabel said she and Joseph had a similar revelation, where she told him about “something really horrible” that happened to her as a child.  “It was one of those moments in the relationship where you’re like, ‘Oh, that explains 40 percent of what I've been wondering about you for 15 years,” Joseph said, adding that it gave context to questions he had about her relationship with her family. During other sessions, they’ve cried, and even vomited.  Dr. Reid Robison, chief clinical officer at Numinus, a mental health care company that provides ketamine-assisted therapy to couples in the U.S. and Canada, said having one partner supporting the other as they work through trauma can be a powerful bonding experience.  “We can identify the barriers that we have to love in ourselves, and then we can just do it so much more freely in our partnership.” Numinus charges around $300 for dosing sessions, but typically a person also has integration sessions afterwards to talk about what they learned.   Robison said whether a person is using MDMA or ketamine, the drugs help people in “turning towards each other” instead of turning away. He’s even seen it work with people going through a divorce, helping them to get over old wounds so that they can co-parent better.   Isabel and Joseph have put up signs in their home that say “turn towards”—gentle reminders that they’ve put in place to integrate the lessons they’ve learned while on MDMA. She said they’ve managed to break a pattern where she would complain about something, and he would withdraw, causing her to also pull away.  Both of them said doing MDMA, which boosts a person’s levels of dopamine and serotonin (neurotransmitters that impact pleasure and sexual desire), has also greatly improved their sex life.  “We had a good sex life, but now we have an amazing sex life,” Isabel said, noting they’ll typically put in five hours of work on their relationship before having sex during one of their resort stays. “It really allowed us to explore breathing together and doing all these like deepening, like soul connection things.”  Joseph said he considers MDMA a medicine, not a drug, and that it should be legally available to people. In fact, it was legal and used for couples therapy in the 1970s and 1980s, before being designated a Schedule I drug in 1985, meaning the government determined it had no medical use and a high potential for abuse. <a href="https://www.frontiersin.org/articles/10.3389/fpsyg.2021.733456/full" target="_blank">Early reports </a>found that it was useful in navigating relationship issues and communication.  Depending on what happens with the FDA’s evaluation of MAPS’ study, it may soon be available for people with PTSD.  Robison said that could open the door for it being allowed to be used for people with other issues, though it’ll be a slow process. He said people with PTSD can also struggle with relationships or have depression and anxiety, though, so “there are ripple effects to their healing work that will be felt in their partnerships.”  He said more research is needed on the impact of psychedelics on couples and he expects to see more therapists wanting to work with it in the years to come.

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Couples Are Doing MDMA and Ketamine Therapy To Save Their Relationships

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Ketamine

While ketamine-assisted therapy clinics have ballooned around the country, ketamine is not approved by the FDA for therapeutic purposes. It is a legal anesthetic that&#x2019;s prescribed for mental health conditions off label.

The US Is One Step Closer To MDMA Therapy

Couples Are Doing MDMA and Ketamine Therapy To Save Their Relationships

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