FDA Clears Researchers To Study MDMA Use By Therapists Being Trained In Psychedelic Medicine

The Food and Drug Administration (FDA) has already authorized clinical trials into the therapeutic potential of MDMA for patients with post-traumatic stress disorders—but now it’s given the green light to a psychedelics research institute to expand its studies by administering the substance to certain therapists.

Volunteer therapists who are being trained to treat people with PTSD will be able to participate in the Phase 1 trials to gain personal experience with the treatment option. This is a complementary research project that comes as the Multidisciplinary Association for Psychedelic Studies (MAPS) is in the process of conducting Phase 3 trials involving people with the disorder.

The development comes months after Canadian regulators announced that certain therapists would be allowed to take psilocybin in order to gain a better understanding of the psychedelic when treating patients.

MAPS sought permission to proceed with the therapist-specific trials in 2019, but FDA placed them on a 20-month hold because of concerns about the merits, risks and credentials of investigators. MAPS appealed that hold, providing evidence about the study’s scientific value and ability of its staff, and FDA cleared them on Tuesday.

The U.S. FDA granted MAPS' appeal of the clinical hold on the Phase 1 #research study to assess the safety and psychological effects of #MDMA-assisted #therapy in healthy volunteer therapists.

Read the full press release: https://t.co/1PUJ9mpIQkpic.twitter.com/MnEyUSY6TB

— MAPS (@MAPS) May 13, 2021

The organization “chose to dispute” FDA’s hold not just because of the impact it had on the planned studies, “but in an attempt to resolve an ongoing issue with the FDA regarding investigator qualifications across studies,” it said in a press release on Wednesday.

“While the term ‘dispute’ may seem adversarial, this process can actually strengthen the relationship and trust between us and our review Division and ensures the Division has support on this project from the [FDA] Office of Neuroscience,” MAPS Public Benefit Corporation (PBC) CEO Amy Emerson said. “This decision demonstrates how our strategic, data-driven strategy in challenging the FDA rulings can be successful.”

Now MAPS is able to launch the Phase 1 clinical trials into MDMA-assisted therapy for therapists.

It will be designed to “measure development of self-compassion, professional quality of life, and professional burnout among clinicians delivering the treatment to patients,” the association said.

Getting personal experience with the substance “is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.”

This will “support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers,” and it “builds capacity to deliver quality, accessible care to patients, pending approval of MDMA-assisted therapy as a legal prescription treatment,” MAPS PBC Director and Head of Training and Supervision Shannon Carlin said.

FDA first granted MAPS’s request for an emergency use authorization for MDMA in PTSD in 2017. The organization expects to complete its Phase 3 trails in 2022.

The scientific expansion move also comes as the psychedelics decriminalization movement continues to build in the U.S.

Nebraska Activists Relaunch Medical Marijuana Ballot Campaign After Legislative Filibuster Blocks Bill

Psychedelics Group Raises $30 Million From Execs At GoDaddy, SpaceX And Others For MDMA Study

The nation’s leading psychedelics research organization announced on Thursday that it has raised $30 million in donations—including from several notable business leaders outside the drug policy realm—that will enable it to complete a study on using MDMA to treat post-traumatic stress disorder (PTSD).

The Multidisciplinary Association for Psychedelic Studies (MAPS) said it will use those funds to conduct a Phase 3 trial on the substance, which is commonly called ecstasy, in hopes of gaining approval from the Food and Drug Administration (FDA). The federal agency has already designated MDMA as a “breakthrough therapy” based on findings from the group’s earlier trials.

About 2,500 individual donors helped MAPS reach their fundraising goal within six months. Here are some of the notable contributors:

-Bob Parsons, founder of GoDaddy ($2 million)

-Blake Mycoskie, founder of TOMS Shoes ($1 million)

-John Gilmore, cofounder of Electronic Frontier Foundation ($1 million)

-David Bronner, CEO of Dr. Bronner’s ($800,000)

-Joby Pritzker, managing director of Tao Capital Partners, board member of Marijuana Policy Project and cousin of Illinois Gov. J.B. Pritzker ($3 million)

-Steve Jurvetson, board member of SpaceX and Tesla ($2.6 million)

-Tim Ferriss, tech investor, author and podcaster ($1 million)

Ferriss played a significant role in the fundraising campaign’s success, helping to secure an initial $10 million in philanthropic donations for a challenge grant.

During a press conference, MAPS staff and donors talked about the challenges of fundraising amid the coronavirus pandemic, but they expressed optimism that, with this funding, they are nearing the finish line to complete the Phase 3 trial and provide PTSD patients with legal access to MDMA.

MAPS says they hope to be granted FDA approval as early as 2022.

MAPS and the #Psychedelic Science Funders Collaborative (PSFC) today announced the completion of the Capstone Campaign, a non-profit fundraising effort to fund the final research required to seek U.S. FDA approval of #MDMA-assisted psychotherapy for #PTSD. https://t.co/L8IkJBieFQpic.twitter.com/RpI1qoaika

— MAPS (@MAPS) August 20, 2020

Asked about the role that the localized psychedelics reform movement might have played in the fundraising campaign, MAPS Founder Rick Doblin told Marijuana Moment that their research objectives and the activists’ legislative objectives have complemented each other.

“I really think that the movements are in parallel,” he said. “The decrim efforts further help to destigmatize and make this research more comfortable and help people feel more comfortable seeking out therapy with psychedelics.”

That said, Doblin noted that “the decrim movement has only taken place after we’ve made a lot of progress with the research—and also the Hopkins team, the NYU teams, the other teams that have worked with psilocybin,” referring to studies from universities, including Johns Hopkins, which last year launched the nation’s first center devoted exclusively to studying psychedelic drugs.

“That kind of preparation then changed a lot of peoples’ attitudes and then they moved towards decrim,” he said. “I think that does help. In fact, we’ve had some indications that that changing of attitudes has made it more comfortable, you could say, for regulators to move forward.”

Joe Green, cofounder of the Psychedelic Science Funders Collaborative, which partnered with MAPS on the fundraising campaign said in a press release that “FDA approval of MDMA-assisted therapy for PTSD could ultimately help millions of people, and that alone is a world-changing impact.”

“We also believe this could be a tipping point for psychedelic medicine overall, leading to a mainstream understanding that psychedelic therapy has the potential to help treat many of the defining mental health crises of our time,” he said.

Also helping to grease the wheels toward expanding psychedelics access are other studies showing therapeutic potential. For example, a scientific review published last year found that “MDMA-assisted psychotherapy demonstrated a high rate of clinical response, remission, with a large effect size at reducing the symptoms of PTSD.”

Earlier this year, a federal commission tasked with developing recommendations to improve mental health treatment for military veterans released a report advising that Congress and the executive branch promote research into the therapeutic potential of marijuana and psychedelics such as psilocybin mushrooms and MDMA.

Researchers at Johns Hopkins also recently announced that they will be collaborating with a Denver-based organization to collect surveys from people about their “real-world” experiences with psilocybin mushrooms.

There are signs that the resurgence of psychedelic science is having an effect on the political world as well.

Rep. Joe Kennedy III (D-MA), who was formerly a staunch opponent to cannabis reform, said during a virtual town hall event this month that he’s been “diving into some of the issues around the medicinal use of certain psychedelics that, at least at this point, show some promise with regards to addressing issues in depression and particularly PTSD.”

As researchers and regulators work to get certain psychedelic medications to patients, activists across the country are pushing to reform laws governing entheogenic substances.

A measure to effectively decriminalize a wide range of psychedelics has officially qualified for the November ballot in Washington, D.C.

In May 2019, Denver became the first U.S. city to decriminalize psilocybin, with the approval of a local ballot measure. Soon after, officials in Oakland, California, decriminalized possession of all plant- and fungi-based psychedelics. The City Council in Santa Cruz, California, voted to make the enforcement of laws against psychedelics among the city’s lowest enforcement priorities in January.

Oregon’s secretary of state confirmed last month that separate measures to legalize psilocybin therapy and decriminalize possession of all drugs while expanding treatment services will appear on the November ballot.

Canada’s health minister recently granted exemptions allowing certain cancer patients to legally use psilocybin for end-of-life care.

Watch The First Ad For Oregon’s Drug Decriminalization Ballot Measure

Photo by Pretty Drugthings on Unsplash.