The San Francisco Chronicle: Patients in MDMA Clinical Trial Find Drug Beneficial 

Summary: Don Lattin of The San Francisco Chronicle interviews MDMA-assisted psychotherapy study participants Andy Gold and John Saul to discuss their experiences of overcoming anxiety associated with life-threatening illness after participating in a MAPS-sponsored clinical trial in Marin, Calif. The article outlines the history of MDMA being used as an adjunct to psychotherapy before and after its criminalization in 1985, highlighting MAPS’ plan to complete the research necessary to develop MDMA-assisted psychotherapy into an FDA-approved prescription treatment by 2021. “My heart really cracked open,” explains MDMA-assisted psychotherapy study participant John Saul. “It helped me overcome my fear-based defenses."

Originally appearing here.

An Oakland attorney battling cancer and a Sausalito yacht broker with an equally terrifying disease sit side by side inside a cozy psychedelic psychotherapy center overlooking Mount Tamalpais. Andy Gold, the lawyer, and John Saul, the boat salesman, are perched on a piece of furniture both had gotten to know well over the past six months: “the tripping couch.”

Gold and Saul are among the first research subjects to complete a months-long clinical drug trial to determine whether psychological trauma sparked by life-threatening diagnoses such as theirs can be lessened through intense, five-hour sessions of talk and music therapy aided by MDMA  a substance better known as the illegal party drug ecstasy.

Guided by therapists conducting the study for the Multidisciplinary Association for Psychedelic Studies, or MAPS, in Santa Cruz, both men say they have come out of the experience changed.

Gold, 62, who was struggling with the psychological aftermath of colon cancer, said he’d become fearful. “I felt lost, like I had no purpose.” The MDMA-assisted therapy, he said, “gives you the ability to look inside and go through the closets of your life. It gives you access to your emotional content.”

‘I had a vision’

For three years, Saul, 50, had been living with the intense pain and existential uncertainty of systemic scleroderma, an incurable autoimmune disorder that hardens the skin and can be fatal if it spreads to the lungs or kidneys.

In his MDMA-fueled sessions, he said, “I had a vision of my adult, courageous self without a molecule of fear, finding this cowering, shivering little child, another version of myself, and taking him under his wing and saying, ‘Everything is going to be OK.’”

The two men spoke about their experiences in an interview at the San Anselmo therapy center where the MDMA study was conducted by two researchers, Dr. Phil Wolfson and his partner, Julane Andries, a licensed family therapist.

Their clinical trial is one of a number of studies around the country designed to persuade theFood and Drug Administration to change the legal status of MDMA so it can be used by therapists treating patients for depression, post-traumatic stress disorder and other psychological maladies.

Drug banned in ’85

Ecstasy has been classified as a banned Schedule 1 drug since 1985, when the federal government cracked down on it. Until then, the drug had been used legally by therapists. But widespread use at dance clubs, music festivals and elsewhere led to some deaths, typically when taken to excess or mixed with other drugs, prompting the government to act.

Under federal law, Schedule 1 drugs, which range from marijuana to heroin, are considered to have a high potential for abuse and no current medical value. But they can, under the law, be used in FDA-approved research settings that are monitored by the U.S. Drug Enforcement Administration.

FDA officials approved Wolfson’s study after earlier drug trials that showed MDMA can be safely used in a clinical research setting. The first group of six volunteers, which included Gold and Saul, have completed the Marin County study, and Wolfson is now recruiting a dozen more to finish his project.

So far, there have been no serious health problems in a series of recent clinical drug trials.

The largest of the studies under way — one involving U.S. war veterans and others struggling with PTSD — is expected to begin its final phase of the long process required before the federal government would reclassify MDMA. That phase, which should begin next year, will involve at least 400 volunteer subjects at a half-dozen clinics in cities around the country, most likely including one in the Bay Area.

The FDA has said it does not necessarily support ecstasy’s use for clinical purposes, but Sandy Walsh, an FDA spokeswoman, said the agency has “an obligation to evaluate the data and do what the data support, such as allow a trial to proceed.”

If MAPS-sponsored therapists can show the same reduction of symptoms in that larger group of PTSD sufferers as they did in the earlier studies, drug decriminalization advocates hope the Food and Drug Administration will then reclassify ecstasy and allow its routine use as a psychotherapy tool. Those final studies are expected to take another five years.

Provides access to emotions

Scientists are still figuring out exactly how ecstasy works in the human brain.

Wolfson said MDMA affects two neurotransmitter sites that “create empathy for oneself and others and a greater tolerance for negative and traumatic experiences.” During psychotherapy sessions, he said, this new openness allows “greater access to difficult emotions and reactions.”

Brain scans of people on MDMA, he said, show what he called a “down regulation of the amygdala,” an almond-shaped set of neurons located in the brain’s temporal lobe that manages emotions, and that correlates with emotional changes observed in clinical practice, Wolfson said.

One of the most important aspects of psychedelic-assisted psychotherapy is helping patients find ways to take the lessons learned on MDMA and use them in their everyday lives without the drug. That’s very different from other psychological medications, like anti-depressants and tranquilizers, which patients must continue to take every day for them to be effective.

Before working with Wolfson, Saul, a former college wrestler and marathon runner, had been so weakened by scleroderma that he could barely walk from the waiting room to his doctor’s office. “I’d get a heart rate of 140 just turning over in bed,” he said.

Last spring, Saul’s mother showed him a story in The Chronicle about a team of Marin County therapists who were recruiting volunteer research subjects who had developed extreme anxiety or depression as they faced life-threatening illnesses.

Volunteers split

Subjects would be divided into two groups — one would get MDMA and the other a placebo. Both would receive intensive psychotherapy and emotional support, but neither the therapists nor the subjects would know which group was which until they had completed two of three therapy sessions.

Saul was certain he’d be a perfect subject. “You are almost sure to get depressed with this disease. It turns your life around 180 degrees,” he said. “It gives you an acute awareness of the tremendous overlap between physical and mental pain, and can spark a spiritual crisis. That’s something that has not really been addressed in Western medicine, but I’m acutely aware of it.”

While he’d never taken ecstasy, Saul had dabbled with mescaline and other psychedelic drugs as a teenager.

He wound up being one of the two
Wolfson subjects randomly chosen to get the placebo during his first two sessions. It surprised him when that was revealed to him.

“I was so ready for this and had so many expectations that I was 100 percent sure I’d been dosed,” he said.

Research subjects who get the placebo are eventually allowed to have three sessions fully aware they are getting MDMA. When Saul finally got the real drug, he saw the difference and soon realized how the medicine could help him face the fear of dying from his disease.

“I was very anxious about the disease getting into my lungs,” he said. “During the first MDMA session I was getting these deep, clear breaths. It was great. Then Julane, said, ‘Notice how you are breathing.’”

Saul started to cry as he remembered the moment.

Later, working with Wolfson and Andries, he said he developed tools to deal with the fear he was feeling.

“These visions would bubble up and come to me piece by piece,” he said. “It was like parting a door of beads and looking into that room and then this room. Do I want to work on that or back off and go into another room?”

Saul said the sessions on MDMA have inspired him to find ways to help other people with slow-moving, life-threatening disease like his own.

“My heart really cracked open,” he said. “It helped me overcome my fear-based defenses.”

Delayed reaction

Gold’s cancer had been in remission for several years. But he had what he now sees as a long-delayed emotional reaction to the trauma from colon surgery, a brutal chemotherapy regime and a medical test that indicated — falsely, it turned out — that he had another form of cancer. He’d gone to see the psychiatrist who referred him to Wolfson at the suggestion of his wife.

Having come of age in the late 1960s and early 1970s, Gold had smoked pot and dabbled with psychedelic drugs, which scared him more than enlightened him. “The last time I took a psychedelic was when I was 21, and it was a sort of dark experience for me. So it had been 40 years,” he said.

Gold had never taken MDMA.

“I knew that MDMA had a reputation as a party drug,” Gold said, “but I’d also heard that it was an empathogen, meaning that it opens you up to empathy and provides a window into yourself.”

After passing through the study’s screening process and preliminary therapy sessions, Gold was ready for his first experience with MDMA.

Gold took the pill and watched as Wolfson did a little opening ritual. “They bang on some drums and gongs and evoke the spirits,” Gold recalled. “I’m a skeptic, so I couldn’t resist joking around with him a little about that.”

Feeling nervous, and remembering his bad trip decades ago, Gold admitted he “had all his defense mechanisms up” as he waited for the drug to take effect. Twenty minutes … 30 minutes … 40 minutes passed and he didn’t feel a thing. He was about to conclude that he’d gotten the placebo when it hit him.

“All of a sudden, it was like I dove 10 feet underwater into some rushing stream,” he recalled. “I went out completely. I lost touch with the outside world. There werea couple hours that went by that are lost to me. It was like my psyche was knocked down so that I could start over again.”

The real therapy for Gold started a month later during his second MDMA-assisted session. Wolfson and Andries worked with him to explore any insights he had while on the drug, and encouraged him to use that knowledge to make changes in the way he sees himself and interacts with others.

“I saw that out of my cancer, I had become fearful,” he said. “I couldn’t be in crowds. I wasn’t doing the things in my life that gave me pleasure, like being active in the world.”

A dozen more in study

Twelve more subjects will go through the Marin County drug trials over the next year before the data are analyzed and the findings are written up. Wolfson is confident the study will be a success.

“We are seeing moving and wonderful changes in people,” he said. “MDMA opens people to conversation, examination and empathy.”

His work is a small part of a larger research effort into potential medical benefits of MDMA and another banned psychedelic compound, psilocybin, the active ingredient in “magic mushrooms.” FDA-approved studies with psilocybin, sponsored by the Heffter Research Institute and under way at Johns Hopkins University and New York University, are also focusing on psychological treatment of cancer patients.

Not everyone in the emerging field of psychedelic-assisted psychotherapy thinks MDMA — which elevates heart rate and blood pressure — is an appropriate drug for patients facing a terminal illness.

“MDMA can be very stressful on the body physically, particularly with people with serious medical illness. The last thing you want with someone who is close to death is to push them over the edge and hasten their demise,” said Dr. Charles Grob, a UCLA researcher who has done studies with both drugs.

“Psilocybin has more value when working with people who are very close to death,” he said. “It allows for more in-depth reflection about existential anxiety and existential depression.”

Monitoring vital signs

As far as his study goes, Wolfson said Grob’s concerns about MDMA should not be a problem. People with cardiac conditions or with less than nine months of life expectancy are not allowed to be volunteers, he said, and the vital signs of those who are selected are regularly monitored during the therapy sessions.

Rick Doblin, the executive director of MAPS, said both MDMA and psilocybin are useful for people facing end-of-life distress.

“We’re moving,” he said, “toward the prescription availability of psychedelic psychotherapy with all the tools in the toolbox.”