Summary/Abstract

Since 1986, Rick Doblin has worked to get MDMA-assisted psychotherapy approved as a safe treatment for post-traumatic stress disorder. Phase 3 clinical trials are set for this summer. A wider array of treatments are needed for people with substance abuse disorders. Some psychedelic compounds have been assessed as potential substance abuse treatments with promising results. MDMA may also help treat substance abuse based on shared features with psychedelic compounds and recent reports indicating that MDMA- assisted psychotherapy can reduce symptoms of PTSD. Narrative reports and data from early investigations found that some people reduced or eliminated their substance use after receiving MDMA, especially in a therapeutic setting. 

Content

Ask Rick Doblin why he's on a 32-year mission to get MDMA--the party drug commonly known as "Molly" or "Ecstasy"--approved as a medicine, and he'll tick off three things: The Holocaust. The Cuban-Missile Crisis. The Vietnam War. 

All three events made the 64-year-old entrepreneur conclude that "the world is crazy and people are irrational." And that as a society, in order to survive, we need better, more effective ways to deal with the psychological trauma that arises from horrific situations.

In the early 1980s, Doblin spent time studying (and experimenting with) various psychedelics. At the famous Esalen Institute in California, which sits perched above the Big Sur coastline, Doblin attended workshops with LSD researcher Stanislav Grof, who felt psychedelics had therapeutic potential. Doblin was eventually introduced to MDMA, then a legal drug. He bought doses to share with friends and in one particular case, witnessed how a female sexual assault survivor overcame suicidal thoughts by combining the drug with psychotherapy sessions.

"I saw the power of MDMA. Over the years, this woman was better--it lasted and lasted," Doblin says. "It was a turning point and I knew what I wanted to do with my life."

And then, in 1985, the U.S. government banned MDMA. The drug had left the world of therapy, becoming a recreational hit on college campuses. It was categorized as a Schedule I substance under the Controlled Substances Act, along with heroin and marijuana.

That spurred Doblin to action. He formed the Multidisciplinary Association for Psychedelic Studies, or MAPS, a nonprofit that funds research into the therapeutic potential of psychedelics, and began the long journey to reclaim MDMA as a medicine. 

Today, some three decades later, he is one step closer to convincing the U.S. Food and Drug Administration that MDMA, combined with psychotherapy, is a safe and effective treatment for post-traumatic stress disorder. With Phase 3 clinical trials set to run this summer, Doblin hopes MDMA-assisted therapy will be an FDA-approved treatment by 2021. If all goes according to plan, Doblin envisions his nonprofit morphing into a $100 million pharmaceutical company with psychedelic therapy centers across the country. But money, he emphasizes, is not his driving force. 

Why it matters

To understand why Doblin is motivated to reclaim MDMA as a medicine, consider the story of military veteran Jonathan Lubecky.

On Christmas Eve in 2006, the retired sergeant was driving around Raleigh, North Carolina, looking for help. While being stationed in Iraq for the previous 12 months, he suffered serious injuries after a mortar shell exploded near him. He came home with post-traumatic stress disorder and found that his wife had left him for another man. Lubecky was alone and broken, he says, so he swung by a church but was told the service was full. Then he drove to a nearby army hospital, where he told a nurse he was suicidal. They gave him five pills of Xanax and told him to come back after the holiday, he says.

When Lubecky got home, he swallowed the pills with some whiskey and loaded his Beretta 9 mm pistol with one bullet and pressed the barrel against his temple. He pulled the trigger. Nothing happened--the bullet was a dud. 

"The only peace I knew was the microsecond after the hammer fell because I knew it was all over," says Lubecky, while talking on the phone and smoking a cigarette from his home in Charleston, South Carolina. 

Over the next eight years of "complete hell," Lubecky would try to kill himself four more times. He was in and out of the Veteran Affairs Hospital, and put on all types of medications and attended therapy but nothing helped abate his symptoms.

After his last suicide attempt in November 2013, he applied to be a volunteer in a clinical study funded by Doblin's organization to test how veterans with treatment-resistant PTSD responded to MDMA combined with psychotherapy. Lubecky was accepted and did 40 hours of talk therapy over 12 meetings and three MDMA sessions with psychiatrist Michael Mitheorfer and Mitheorfer's wife Ann, who is a nurse.

"I had daily suicidal ideations. I spent so much time sitting on a bridge, contemplating whether or not I should jump," says Lubecky. "I was worried that my stepson would receive a flag inside a box before he went to college. But now, I'm going to be around. MDMA saved my life." 

Lubecky's success story is not the only one. Dozens of people with serious cases of treatment resistant-PTSD--sexual abuse victims, combat veterans, cops, and firefighters--have reported reduced symptoms after participating in clinical trials funded by Doblin's organization. An FDA spokesperson declined to comment on the existence of any drug trials, but did say the agency allows clinical studies on psychedelics as long as the studies are safe and have a "reasonable" chance of answering questions about the drug's efficacy. 

In November 2016, the New York Times reported that the FDA had allowed a Phase 3 clinical trial of MDMA-assisted therapy, after years of promising results. If the trial can prove that MDMA-assisted therapy is safe and effective for treating PTSD, the drug-therapy combo could become a legal FDA-approved prescription. About 230 patients will participate with about 82 psychotherapists when the study starts in June or July, says Doblin.

A long time coming

In 1912, Merck, the German pharmaceutical giant, invented and patented MDMA, which has a similar molecular structural and pharmacological properties of amphetamine, a stimulant, and the psychedelic mescaline. But Merck did not realize the molecule's power. It wasn't until the 1970s that the legendary U.S. biochemist Alexander Shulgin discovered the powerful entactogenic effects of MDMA, known as "Adam" back then.

Doblin himself was drawn to MDMA because of its ability to produce feelings of empathy or what some might call oneness. "The sense of unity, the sense of connection, and the mystical experience has profound political implications," he says. "If you feel connected to the universe, to the web of life, you won't be as likely to dehumanize people."

Some 25 years ago, with MDMA back in the public domain, Doblin felt so strongly about the drug's potential that he hired a patent attorney to develop what he calls "an anti-patent strategy" so no company, not even his own, could patent therapeutic uses of it. Instead, Doblin hopes to receive an FDA designation called new drug product exclusivity, which would give his company a five-year monopoly. (After five years, other companies can make and sell a generic version.)

To sell MDMA, Doblin created a benefit corporation that is wholly-owned by his nonprofit. That means neither Doblin nor anyone else, has equity in the company. "We are not here to maximize profits--we are here to maximize public health and spirituality," he says.

If Doblin is successful, MDMA will not be a take-home medication akin to say, medical marijuana. It will be more like anesthesia--administered by trained and properly licensed medical professionals in a controlled setting. PTSD sufferers would need to get a prescription, then attend a three-month program of 40 hours of talk therapy over 12 non-drug sessions with three day-long MDMA sessions. 

Doblin, through MAPS, has raised $26.2 million for Phase 3. His organization has received $8 million from the cryptocurrency community. Conservative philanthropist Rebekah Mercer, through her family's foundation, has donated $1 million. 

If approved, Doblin says he plans to launch psychedelic treatment centers around the U.S. to treat PTSD patients. The drug itself would be manufactured by Onyx, a British company; it would be put into capsules by Sharp, a pharmaceutical contracting company in Pennsylvania. The benefit corporation would sell each dose for $150 to $200 a piece and the whole program would cost a patient about $12,000 (unless insurance covers it). MAPS also charges $8,000 to train a provider to be a licensed psychedelic therapist.

Doblin says the company was recently valued at over $100 million, and he estimates about $36 million in profits for the first five years. About 20,000 PTSD patients have signed up online so far, he says. He envisions as many as 16,000 psychedelic treatment centers around the country.

To be sure, Doblin could still run into issues with regulators. If the trials are successful, and the FDA recommends that MDMA should be rescheduled, the recommendation would be handed to the Drug Enforcement Agency to make the final determination. It could be difficult to persuade President Trump's Justice Department, with old-school drug warrior Jeff Sessions as attorney general, that the well-known party drug should be rescheduled, says John Hudak, deputy director of the Center for Effective Public Management at the Brookings Institution.

It will likely help that Doblin has been playing by the all the rules, Hudak says. "Doblin is not advocating for recreational MDMA," he says. "He's been going through the FDA process to create a new medicine based on scientific evidence that will be controlled and dispensed as a pharmaceutical medication."

Perhaps because he's been in it for so long, even Doblin is having a hard time believing that the long-awaited approval could happen. He describes himself as only about "80 percent sure" that the drug will be FDA-approved by 2021. 

"I do not want to understate this challenge," he says. "But when it does happen, MDMA-assisted psychotherapy will be a gift to the world."