Use of MDMA (3,4-Methylenedioxymethamphetamine), most commonly known as the street drug Ecstasy, has been approved by the FDA for supervised use in therapy for treatment of posttraumatic stress disorder (PTSD).

The approval, known as Breakthrough Therapy Designation, was granted alongside approval of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD, in a program designed by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS has been working since 1986 to improve clinical and cultural understandings of the benefits of certain psychedelic drugs and marijuana.

The Breakthrough Therapy Designation is allotted by the FDA to treatment protocols that include single drugs or a combination aimed at treating life-threatening conditions or diseases. It may also be granted to protocols where preliminary research “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,” reports MAPS.

“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” Rick Doblin, Founder and Executive Director of MAPS, said in a statement. “Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”

Under the Phase 3 trials, 200-300 subjects will test the drug or a placebo in three-day-long treatments over a 12-week period combined with psychotherapy sessions.

“Reaching agreement with FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, said in a statement. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”

MAPS says after recently completing its Phase 2 trials with 107 participants, “61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.”

John Krystal, chairman of psychiatry at Yale University and a director at the VA’s National Center for PTSD, told the Washington Post that conventional drugs like Zoloft and Paxil are failing our returning soldiers in a big way. “If you’re a combat veteran with multiple tours of duty, the chance of a good response to these drugs is 1 in 3, maybe lower,”  he said. “That’s why there’s so much frustration and interest in finding something that works better.”

The MAPS-approved protocol combines psychotherapy sessions with supervised administration of MDMA in a clinical setting of three single-dose treatments.

“Phase 2 clinical trials have shown that MDMA can reduce fear and defensiveness, enhance communication and introspection, and increase empathy and compassion,” MAPS says, noting that the combined neurological effects can enhance the therapeutic process for people suffering from PTSD.

According to MAPS, approximately seven percent of the U.S. population and 11-17 percent of U.S. military veterans experience PTSD will experience PTSD.

“As of June 2016, more than 868,000 veterans were receiving disability compensation for PTSD, with an estimated taxpayer cost of $17 billion per year,” MAPS explains. “PTSD is a stress-related condition associated with reduced cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, and increased risk of depression and suicide. In the general population, 27% of suicides are associated with PTSD.”

Drugs like MDMA, Doblin told the Post, “are a tool that can make people more compassionate, tolerant, more connected with other humans and the planet itself.”

Last April, Dr. Bronner’s, the popular natural soap and personal care company, pledged $5 million to MAPS’ research.

“There is tremendous suffering and pain that the responsible integration of MDMA for treatment-resistant PTSD will alleviate and heal,” David Bronner, Cosmic Engagement Officer (CEO) of Dr. Bronner’s, said in a statement. “To help inspire our allies to close the funding gap, my family has pledged $1 million a year for five years—$5 million total—by far our largest gift to an NGO partner to date. In part, we were inspired by the incredible example of Ashawna Hailey, former MAPS Board member, who gave MAPS $5 million when she died in 2011.”

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Imagine not being able to get treatment for an illness because the treatment is illegal.

In “The Agony & The Ecstasy,” Charles Shaw examines how MDMA can help people with PTSD recover. The catch, though, is that MDMA is illegal—even though it could be beneficial. This fact lead Shaw down a road that ended at a prison.

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Has the War on Drugs got it all wrong? A new research study finds use of hallucinogens, including psychedelic “magic” mushrooms, mescaline, and LSD, doesn’t cause long-term psychological problems. In fact, use of psychedelics may even reduce the need for mental health treatments.

There’s a renaissance happening around hallucinogens. Westerners seeking physical and emotional healing are traveling deep into Amazon jungle territory to drink a potent plant brew called ayahuasca, rich in DMT, “the spirit molecule.” [Full disclosure: I recently traveled to the Colombian rainforest to drink ayahuasca under the supervision of shamans.] They’re also venturing into West Africa for iboga healings with the Bwiti tribe in order to cure themselves of addiction to drugs like heroine. Others are participating in studies, like those conducted by the  Multidisciplinary Association for Psychedelic Studies (MAPS), which is proving the efficacy of MDMA (the active ingredient in the street drug Ecstasy) in treating PTSD and other serious psychological issues. LSD and psilocybin mushrooms are being used to ease the anxiety experienced by cancer patients. Go to any of the myriad music, art and culture festivals or gatherings cropping up around the globe (including those focused on the use of psychedelics), and you’ll find a wide variety of people using hallucinogens in all manners of exploration, from straight up dancing and partying to the ceremonial and healing applications.

Approximately one in six Americans between the ages of 21 and 64 has tried hallucinogens. Still, the substances are highly criminalized, and, perhaps even worse, stigmatized as doorways into madness and addiction. Use of hallucinogens is a practice deemed only slightly acceptable during those experimental college years where promiscuity and binge drinking are also sloughed off as young adult rites of passage. Speaking candidly about the use of hallucinogens is akin to coming out of the closet about being a lesbian or homosexual just a half century ago. Announcing an unconventional sexual orientation would often earn you pariah status; it wasn’t something to discuss with just anybody. And the same goes for the medicinal benefits of hallucinogens. (At the very least, you don’t inhale.) In most social circles in our Western culture, using psychedelics is formidable for anyone over age 21. It’s not casual dinner conversation. Antidepressants and prescription anxiety drugs? Well, they’re the new normal. You can talk about those all you like. But tell the wrong person that you participated in an experimental MDMA trial to deal with crippling PTSD? It’s likely to be almost as mood-altering as the drugs themselves.

But could we be all wrong about psychedelic medicine?

According to researchers out of the Norwegian University of Science and Technology’s Department of Neuroscience who published their findings in the recent issue of the journal PLOS One, there were no links that connected the use of psychedelic hallucinogens to a wide range of mental health problems including mood and anxiety disorders, psychosis and general psychological distress.

The research team reviewed survey data collected between 2001 and 2004 from more than 130,000 randomly selected Americans. More than 20,000 of the subjects admitted to using hallucinogens, and the findings were consistent among the individuals: “The lack of association between the use of psychedelics and indicators of mental health problems in this large population survey is consistent with clinical studies in which LSD or other psychedelics have been administered to healthy volunteers,” the researchers wrote.

NPR reports that the study does have some limitations, however: “It’s possible that healthier people are more likely to take psychedelics than those already struggling with mental illness, for instance.” And the study also didn’t consider dosages or quality of the drugs, nor did it look at family histories of mental health, “which could be an important factor.”

While still illegal in the U.S., the amount of research now being done to explore the potential benefits of psychedelics is increasing. Matthew W. Johnson, a psychologist in the psychiatry department at Johns Hopkins School of Medicine told NPR that there seems to be “no evidence of overall negative impact — and even some hints of benefit — associated with the use of psychedelics.” Johnson recently explored the effects of psychedelic mushrooms on cancer patients to help them deal with the anxiety and depression around their illness.

MAPS’ groundbreaking work on MDMA and PTSD has already shown that “MDMA in conjunction with psychotherapy can help people overcome PTSD, and possibly other disorders as well.” They note that MDMA is known for “increasing feelings of trust and compassion towards others, which could make an ideal adjunct to psychotherapy for PTSD.”

And while the Norwegian researchers acknowledge their study doesn’t allow conclusions about causality, the team found that there is a lack of evidence “that psychedelics cause lasting mental health problems.”

Mental health issues in the U.S. are skyrocketing, based on prescription drug sales for mood enhancers and antidepressants. As Americans struggle to handle their mental conditions, just as many struggle to get a grip on healthy eating habits, the pro-psychedelic community is hopeful that a return to more ‘natural’ treatments for mental and emotional issues may begin to become less stigmatized. And what researchers are finding supports the theories that there may not only be a reduced risk of harm from hallucinogens, but inherent mental health benefits to exploring those edge realms of consciousness as well.

Unlike pharmaceutical drugs, which require long-term usage, and can include numerous undesirable side-effects, a few “psychedelic sessions” can help individuals to acknowledge, confront and resolve certain issues, particularly those that are mental, psychological or emotional–which can often manifest as physical conditions. According to MAPS, “The deep personal and often spiritual experiences enabled by the careful use of psilocybin and LSD are well known.”

Timing of the research couldn’t be better for mood-altering substances, either. CNN’s chief medical expert, Dr. Sanjay Gupta, recently apologized for “misleading Americans” over the safety and benefits of medical marijuana. He’s released a documentary on the subject and said “sometimes marijuana is the only thing that works.” Perhaps he’ll explore LSD next.

Keep in touch with Jill on Twitter @jillettinger

Image: doomz, kt lindsay

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