Nonprofit navigates politics, science to put MDMA on path to clinical use

(MCT) -- SANTA CRUZ, Calif. - When it comes to psychedelics, an under-the-radar nonprofit research group is opening people's minds.

The Santa-Cruz-based Multidisciplinary Association for Psychedelic Studies is making serious headway toward bending the boundaries of modern medicine. In several federally-approved clinical trials, the group is effectively treating psychiatric disorders - notably post-traumatic stress disorder - with MDMA, commonly known as ecstasy.

"It permits the possibility of cures, whereas current psychiatric medications are about minimally reducing symptoms," said Rick Doblin, the Harvard-educated founder and executive director of MAPS.

"It's tragic the number of people that have PTSD that have not been successfully treated by currently available medication or psychotherapy."

The association, which moved from Florida five years ago, is thinking big. For nearly three decades it has been trying to change mindsets both in the federal government and in the medical community, and it seems to be on the verge of something that seemed unattainable during the heights of the war on drugs.

Phase II trials being conducted in South Carolina, Colorado, Canada and Israel put MAPS closer to the finish line for FDA approval of therapeutic MDMA use. By administering the drug to patients who've lived through war, sexual abuse and other traumatic events, therapists can help them revisit memories without the fear the subjects normally assign to them.

The early returns are more than positive. Studies are showing MDMA several times more effective than either the antidepressants Zoloft or Paxil at treating PTSD. And unlike those medicines, patients do not need to keep taking the drug to see the benefits - MDMA seems to permanently restructure a patient's relationship to trauma.

Brad Burge, MAPS communication director, likened MDMA to a chemical "security blanket," including the suppression of the amygdala, an area of the brain that modulates emotion and memory. Patients relive the memory, but in a safe context and under the guidance of a therapist.

"If you want to change somebody's relationship with their memory, or with their anxiety ... what it means is getting their attention on it in a different way, and that's often very painful during the treatment. People say its the most difficult conversation, the most difficult time, they ever had in their life. But they do it with this sense of security and comfort because they do it with an experienced therapist," Burge said.

Word of the group's work is spreading, which Burge credits to the success of the research. The studies are small, but more than 500 are on a waiting list for the South Carolina trial, and more than 250 for the Colorado trial.

Rachel Hope, also known as subject 7, has been though South Carolina-based trials. Her traumas accumulated through the years, including neglect and childhood sexual abuse and torture - her mother left her with someone she described as a "cultish" figure who turned out to be a pedophile. At 11, she was hit by a truck and had her face crushed, and while the physical damage healed, the mental scars never did.

Hope says she became intense and hyper-vigilant at a young age, a drive that helped her become a successful real estate developer in Hawaii. But she knew something was wrong, with panic attacks and nightmares leading her try Western medicine, Eastern medicine, psychotherapy, hypnotherapy, New Age treatment, personal development courses, yoga and a cabinet full of medicine.

Her health was in decline. Not only did she often have trouble leaving the house, but her hair and nails were brittle and she had ulcers. She wouldn't smoke or drink, or use any drugs, maintain as tight a grip as possible on reality.

"I spent over a million dollars out of pocket trying to get well," Hope said, driven in part by her growing son. But she gave up. "I said, 'Sorry, I'm a disabled mom.'"

An assistant decided to confront her, printing out a three-inch stack of protocols for PTSD trials and delivering them. She read them over the next few weeks, drawn to a study using a substance she'd never heard of: MDMA.

"What got my attention was it was so hard. Someone was trying to sabotage this study. There was no way they could ever meet this protocol," Hope said.

She volunteered and was selected. She remembers the none-too-pleasant sensation of taking the drug the first time - its street name, ecstasy, was poorly named, she thought. A therapist walked her through the memories that seemed to imprison her daily life.

"It lit up every neuron in my brain at once. I was almost overwhelming to me," Hope said. "It felt like it was breaking my heart, because I was seeing this expanded perspective on everyone, and myself.

"It was almost violent because it was like breaking me out of this prison of judgments and lies."

Hope said the first treatments took away 90 percent of her symptoms. Follow-ups took away the final 10 percent, and she now considers herself cured.

"If it wasn't for MDMA-assisted psychotherapy, I probably wouldn't be alive today because I was deteriorating so quickly," Hope said, stressing that the memories aren't gone, but her relationship to them changed.

"The treatment heightened my awareness but reduced my anxiety," Hope said. "I was introduced to my very, very highest self, and my highest self was able to kind of rewire my brain. I still know what happened, but my body wasn't thinking that it's going to happen again, every single day."

While she still doesn't use drugs and doesn't recommend them to anyone outside a clinical setting, Hope is now a champion for MDMA-assisted therapy. She said she owes her life to the people who gave MAPS money to fund the studies, and sometimes gets angry when she meets people who suffer now the way she once did.

"Not only that, I've come to believe this treatment is the right treatment for many people who suffer, from marital problems to depression to alcohol and drug addiction," Hope said. "It's all PTSD masquerading as some other issue."

Just how MAPS got to this point, ducking waves of national hysteria and convincing rock-ribbed veterans that something they know only as a club drug might help, is a story of savvy and patience.

By 1982, Doblin was a devotee of the potential for psychedelic therapy. That's when, while on a trip to Big Sur's Esalen Institute, he heard about MDMA.

The drug had a background in psychotherapy, but it had hit the streets as a recreational shortcut to bliss. It was especially popular on the club and festival circuit, because it enhanced the sensations of music and lights, and could be a stimulant as well.

It would soon be outlawed, despite Doblin's attempts to intervene in the Drug Enforcement Agency's action. He organized monks, priests, rabbis, therapists – everyone he could think of.

"At the time the DEA criminalized it, they only knew of it as a recreational drug under the name ecstasy. They had no idea," Doblin said. "The frame that this was just young people hedonistically taking this drug was disrupted by all these people that didn't fit the stereotype."

But in 1985 it was banned as a Schedule 1 drug with no known medical purpose. Further setbacks came when many, including Orpah Winfrey, touted now-discredited brain scans purporting to show how ecstacy "eats" the brain.

"They were images of blood flow in the brain. They chose to display it in the most provocative and misleading way possible. No scientist believes that it does that," Doblin said.

Doblin founded MAPS in Florida in 1986 – it still works off a supply of MDMA produced by Purdue University at that time - and for several years he was the only staff.

But Doblin's academic career would later hit a wall. He had trouble finding a school willing to entertain his idea for psychedelic-related graduate studies.

"My whole life for 16 years had been in one direction and then I couldn't follow it up anymore. So I went home and smoked a joint," Doblin said. "Marijuana gives you a chance to see things from a broader framework. And I thought, 'The politics is in the way of the science.'"

In 1998, Doblin found a mentor at Harvard's Kennedy School of Government, and he now has a doctorate in public policy. He still lives in Boston - Doblin has never lived in Santa Cruz - but a large staff is here.

Newly schooled in the levers of power, Doblin began working the Food and Drug Administration at a time when research into psychedelics had basically flat-lined. He credits a mid-1990s staff change at the agency for allowing research to go forward.

"We were able to get our first study approved for MDMA," Doblin said. "It really was courageous people at the FDA."

The early trials were promising, and MAPS was careful to spread its research around the globe to many different political and regulatory environments.

The groups also chooses patients carefully, choosing patients for whom other treatments have failed. They tend to be soldiers and firefighters, people who tend to be insulated from politics: Who would say no to a veteran trying to find a way back to normal after being blow off a Humvee by a roadside bomb?

"We work with the hardest cases on purpose," Doblin said. "We have to be political in what sort of science we do and what sort of patients we heal."

As many as one in 10 U.S. residents are living with PTSD, and the rates are higher in countries where conflicts are endemic. PTSD has been associated with psychiatric disability, drug abuse and suicide, and as an epidemic has largely confounded treatment.

MAPS believes the benefits of MDMA could be much broader than PTSD, already conducting experiments on easing anxiety in patients facing terminal illness. It has also been approved to study using it to treat social anxiety in autistic adults.

Although MDMA is promoted as an alternative to a class of drugs that own a significant market share, the pharmaceutical industry has not moved against MAPS. When contacted for comment, the American Psychiatric Association was also muted, saying it is not an FDA-approved medicine and therefore doesn't recommend it for clinical practice.

"By definition, non-FDA approved medications may have safety concerns and risks of harm and should therefore only be used according to research protocols that have been reviewed and approved by an Institutional Review Board to ensure that the protocol includes protections for the research subjects such as informed consent," the group said.

MAPS focuses on science, but spends most of its time on what's needed to push the science forward: fundraising and public outreach. Over the years it has raised more than $18 million. It publishes and sells books on psychedelia, stages conferences and even spreads the word at places such as Nevada's Burning Man Festival. It now has a social media director.

Donors also contribute items to sell on eBay, perhaps the most remarkable being a limited-edition Salvador Dali print. Its donor base tilts heavily to California and especially to Silicon Valley, where the tech industry does two important things: has money to give and exhibits strong libertarian streaks.

Steve Jobs, for one, once said taking LSD was a key experience in his life, and Sun Microsystems founding employee and tech activist John Gilmore is on MAPS' board. When Doblin wanted to relocate here, his team found Ben Lomond first, later resettling in Santa Cruz.

MAPS' interests extends beyond MDMA, into medical marijuana, LSD, psilocybin, even ibogaine and ayahuasca, an intensely psychoactive plant usually consumed as a tea.

A Phase III trial is the final step to widespread clinical use. MAPS hopes to get that study underway in 2016, targeting a 2022 completion date. At $15 million, it would be their most ambitious undertaking yet, with $5 million already given by the estate of a former board member, another tech pioneer who died recently.

If approved, therapists could use MDMA off-label for a variety of treatments, including marriage counseling.

In subtle ways, President Obama's administration is reworking the nation's attitude toward drugs in general, standing pat as Colorado and Washington legalize pot and reworking criminal sentencing guidelines for drug crimes. The White House website now has a section focused on drug policy reform, focusing on science instead of enforcement.

All of which may help MAPS remove the final blockade before MDMA is approve for widespread use.

"I wouldn't anticipate that would be problem, but it's so hard to guess 10 years down the road what the political context would be," said Jag Davies, publication manager at the Drug Policy Alliance, and a former MAPS employee.

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