Santa Cruz Sentinel: Santa Cruz-Based MDMA Therapy for PTSD Reaches Final Testing Phase

Summary: Santa Cruz Sentinel covers MAPS’ studies of MDMA-assisted psychotherapy for PTSD by speaking to Brad Burge of MAPS and study participant and veteran C.J. Hardin. “The effects of MDMA help people to open up and process their trauma faster and more deeply than they were able to without the drug,” explains Burge. “What you feel is a giant feeling of, I guess, happiness? And kind of like you lose sense of maybe some of your surroundings. You lose sense of the fact that you’re worried about your surroundings. It gives you like a comfort space,” explains Hardin. “It felt like I had done three years of talk therapy in about eight hours.”

Originally appearing here.

 A $25 million international project seeking FDA approval for the use of the psychedelic drug MDMA to treat post-traumatic stress disorder is headquartered in a two-story house on Mission Street.

The house — at 1115 Mission St., two doors down from Emily’s Bakery — is the main office of the Multidisciplinary Association for Psychedelic Studies, a nonprofit advocating for the prescription use of psychedelic drugs and marijuana.

For roughly the past two decades, MAPS has led federally-approved research into the use of MDMA, commonly known as ecstasy or molly, to treat post-traumatic stress disorder.

The therapy’s key is that ingestion of MDMA is closely monitored and coupled with intensive all-day psychotherapy, said Brad Burge, MAPS’ director of strategic communications.

“The effects of MDMA help people to open up and process their trauma faster and more deeply than they were able to without the drug,” said Burke.

Come April, the project will enter its third and final phase: clinical trials of MDMA-assisted psychotherapy to treat severe post-traumatic stress disorder. MAPS is seeking around 300 participants at 15 sites across the U.S., Canada and Israel, including two sites in San Francisco.

The nonprofit’s previous trials, which concluded this year, were promising.

Around 68 percent of the 107 participants no longer had post-traumatic stress disorder after two sessions of MDMA-assisted psychotherapy, said Burge. Participants were assessed a year after the two sessions of treatment.

A VETERAN’S STORY

Military veteran James “C.J.” Hardin, a Charleston, South Carolina, resident participated in MAPS’ previous phase of trials in 2014. He had done multiple tours in Iraq and Afghanistan, before leaving the service in 2010.

When he came home, he suffered.

“You avoid things that bring up the prior trauma,” Hardin said. “So for instance, avoiding large crowds, avoiding driving, avoiding going out in the daytime, things like that, just in civilian life. You get so used to the fact that you’ve been in a combat aspect and you bring that home. Especially, the switch just never gets turned off.”

“It could be, just like, for instance, somebody opening a door in the house unexpectedly,” said Hardin. “The change in air pressure in the room, a sudden noise, and all of a sudden my blood pressure would go up. My pulse would race, dry mouth, tunnel vision.”

He had tried unsuccessfully to treat his posttraumatic stress disorder with the antidepressants, a sleep aid, and other prescription drugs, he said.

THE TRIAL

Hardin said he felt mostly cured of the disorder after two full-day sessions of MDMA-assisted psychotherapy, spaced one month apart.

After the first session, “it felt like I had done three years of talk therapy in about eight hours,” he said.

“Once I got home I slept for the first time in years. Like without anything, I just slept,” Hardin said.

The MDMA allowed him to say things in therapy that he had never said to anyone, he said.

“When it comes on, it comes in waves, I guess you say. But the first wave is a big ’un,” Hardin said. “So what you feel is a giant feeling of, I guess, happiness? And kind of like you lose sense of maybe some of your surroundings. You lose sense of the fact that you’re worried about your surroundings. It gives you like a comfort space.”

Hardin said MDMA alone would not have cured him. It was the combined usage of MDMA and intense psychotherapy with a doctor and nurse in the room, he said.

HOW DOES IT WORK?

MDMA is theorized to have three main effects, said Burge.

One is that it can increase attention and access to memories while someone is under the influence. Another is that reduces the fight-or-flight response that’s activated in people with posttraumatic stress disorder, he said.

The third possible effect is that MDMA induces the release of oxytocin, known as the “cuddle hormone” that is released in lactating mothers and in the post-orgasmic state, which creates feelings of intimacy.

“Warmth and closeness may help people who are going through therapy feel more trusting and close with the therapist,” said Burge.

Burge warned that pharmaceutical-grade MDMA is not the same as ecstasy or molly, which drug dealers cut with other substances. And even pure MDMA has negative side effects, such as a “crash,” or short-term depression. The drug can also increase heart rate and blood pressure so it’s not advised for people with cardiovascular or neurological conditions.

It’s also possible to be addicted to MDMA, he said, though it’s unlikely that patients would develop an addiction after a few administrations in a therapeutic setting. People with active drug addictions are not allowed to participate in the study.

SCIENCE COMMUNITY

Greg Fonzo, a clinical psychologist and postdoctoral fellow at Stanford University, said he’s been following the MDMA research since its first trials. Fonzo, who has authored more than a dozen research papers on PTSD and the brain, said the MDMA preliminary results have been “pretty impressive.”

“I think it’s going to be very helpful for some people, but not for everyone,” Fonzo said.

Fonzo said many in the mainstream scientific community are either unaware of MDMA-assisted psychotherapy or view it as a last resort. What’s interesting is that before MDMA became illegal in the 1980s, long before it was a “club drug” used at raves, it was used by psychiatrists in psychotherapy, he said.

“At this point, it’s still considered a fringe treatment, but that’s changing,” Fonzo said. “Over the past few years it’s gained traction and it’s being seen as something that’s not totally crazy to do, and more and more people are starting to accept the idea that it’s a potential option and perhaps a good one.”

FUNDING

Assuming the final phase of testing goes well, Burge said the main obstacle to gaining FDA approval is funding.

MAPS has $7.5 million left to raise toward its $25 million goal for the project.

Major donors have come forward, such as Dr. Bronner’s, the San Diego County-based soap company headed by David Bronner, who serves on MAPS’ board. Dr. Bronner’s has pledged $1 million per year for the next five years.

MAPS, which has around 25 employees nationwide and 17 in Santa Cruz, receives no federal funding. All the money comes through donations, Burge said.

“We’re trying to bridge this line between being a nonprofit relying on donations, being a pharmaceutical company trying to bring a drug to market and also needing to be a startup and nee
ding to grow super fast and embrace the Silicon Valley culture of ‘grow, grow, grow,’ because we need to do this now,” Burge said.