San Francisco Chronicle: Ecstasy Therapy Approved for Trial in Marin County

Summary: The San Francisco Chronicle features a front-page investigative report about MAPS’ ongoing clinical study of MDMA-assisted psychotherapy to treat people with anxiety associated with life-threatening illness in Marin, Calif. The article details how MDMA-assisted psychotherapy is administered within the study protocol, highlights the U.S. government’s approval and recognition of MDMA research, and reviews how the study fits into MAPS’ timeline to develop MDMA-assisted psychotherapy into an FDA-approved prescription medicine. “It’s a really interesting and a very powerful new approach,” explains Dr. Thomas Insel, director of the National Institute of Mental Health. “It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy.”

Originally appearing here.

Three decades after the U.S. government slammed the door on ecstasy, a team of Marin County therapists has gotten permission to use the popular party drug in a study designed to reduce anxiety among people with cancer or other life-threatening disease.

Dr. Philip Wolfson, a San Anselmo psychiatrist and longtime advocate of MDMA-assisted psychotherapy, has begun recruiting for 18 people for his research project, which will be conducted over the next year in his cozy hilltop psychotherapy center overlooking Mount Tamalpais.

The goal of the study is to see whether patients suffering from crippling anxiety, fear or depression over a devastating diagnosis can find relative peace from several extended psychotherapy sessions under the influence of ecstasy.

Ecstasy, the street name for the psychoactive drug MDMA, is a radically different kind of medication for the treatment of anxiety. Rather than calming or sedating, a four- or five-hour psychedelic journey with MDMA, Wolfson said, can be “transformationally potent” when used in a safe, comfortable setting with a pair of trained therapists, one man and one woman.

“It’s a substance that supports deep, meaningful and rapidly effective psychotherapy,” he said.

For Wolfson, the MDMA study is deeply personal. Back in the 1980s, he and his then-wife, Alice, worked with a therapist who used to help them deal with the emotional turmoil their family experienced when their teenage son, Noah, was battling leukemia.

Pain of losing a child

Noah died, but the experience inspired Wolfson to devote his life to finding a way to make this kind of therapy available to other families facing the agony of a dying child or other loved one.

Now he has.

Wolfson has gotten permission from the U.S. Food and Drug Administration to conduct the MDMA study and has obtained a license from the U.S. Drug Enforcement Administration to administer the otherwise-illegal drug to patients.

Sandy Walsh, an FDA spokeswoman, said her agency has determined that previous scientific studies of MDMA have shown the drug can be safely used by research subjects under proper medical supervision.

“If a drug works for a disabling condition and can be labeled to be used in a safe way in that population,” she said, “then we think we have an obligation to evaluate the data and do what the data support, such as allow a trial to proceed.”

Others in the federal government are also showing interest in the MDMA study. Dr. Thomas Insel, director of the National Institute of Mental Health, said his agency is following several privately funded studies that are using psychedelic drugs in conjunction with psychotherapy to treat a variety of mental disorders.

“It’s a really interesting and a very powerful new approach,” Insel said. “It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy.”

8-hour therapy sessions

For Wolfson’s study, the participants will go through preliminary therapy. Thirteen of them will then sit through three eight-hour therapy sessions after taking the drug while the remaining five patients will get a placebo capsule.

Follow-up counseling and psychological testing will compare the mental health and well-being of each group — a process that could take 15 months.

Those who randomly get the placebo will later be given the opportunity to undergo actual MDMA sessions with Wolfson and his partner, Julane Andries, a licensed family therapist.

“We’re not just sitting in an office for 50 minutes,” Wolfson said. “We go for as long as we need in a warm, friendly atmosphere. We get very close to these people. This is a revolution in therapy and needs a different approach.”

The Marin County project is sponsored and funded by Multidisciplinary Association for Psychedelic Studies, or MAPS, a Santa Cruz organization that has already shown success in a larger study in South Carolina of MDMA-assisted therapy for sexual abuse victims and Iraq War veterans suffering from post-traumatic stress disorder. Four of five patients in that study radically improved when given MDMA, the researchers said in a paper published in the Journal of Psychopharmacology.

MDMA is a psychoactive substance known for producing feelings of increased energy, euphoria, emotional warmth and empathy toward others. For that reason, many people refer to the drug as an “empathogen” or “entactogen.”

“MDMA can help us experience awe, and that eases anxiety and depression,” Andries said. “Later, you can hold onto that memory of feeling vital, alive, happy and full of awe.”

Like many drugs, licit and illicit, MDMA can have serious side effects, such as increased heart rate and blood pressure. For that reason, people with cardiac issues are not allowed to participate in the research project. Those who are chosen are given detailed warnings about side effects, but are also informed that more than 1,000 people people have received MDMA in research settings, without any serious problems happening.

Ecstasy became popular in the late 1970s and early 1980s among a circle of underground chemists, therapists and psychedelic drug enthusiasts. It later became infamous as the drug that fueled all-night dance parties known as raves, and the drug became a sacrament of sorts at the Burning Man celebrations in Nevada’s Black Rock Desert.

Work to reclassify drug

In 1985, the federal government cracked down on the burgeoning recreational, spiritual and therapeutic use of ecstasy, banning it under Schedule I, the strictest prohibition for narcotics under federal law. The government determined the drug was “easily abused and without medical value.”

Wolfson and other MAPS leaders hope that the Marin County experiment and the more extensive tests with PTSD victims will persuade the FDA and the DEA to reclassify MDMA and allow doctors to prescribe the medication for use with trained psychotherapists for their PTSD and terminally ill patients.

John Hartberg, a 27-year-old neuroscience study coordinator working with Wolfson and Andries, said that mainstream culture has begun to “accept the validity of altered, nonlinear states of reality” and that “mystical or spiritual experiences are powerful and an essential part of healing.”

‘No longer a fringe thing’

“This is becoming a totally legitimate and exploding field with so much potential,” said Hartberg, who holds a bachelor’s degree in neuroscience from the University of Minnesota and is now prescreening potential res
earch subjects in Marin.

“This is no longer a fringe thing,” he said.

Perhaps, but don’t expect psychiatrists to start writing prescriptions for ecstasy anytime soon.

Joseph Moses, a special agent with the DEA, said the fact that his agency has issued licenses for MDMA research does not necessarily signal a new openness by federal agents to the medical use of psychedelic drugs. The agency’s role, he said, is simply to certify that a “security infrastructure” is in place to ensure that is used only for its intended purpose during the research studies.

Other federal agencies, notably the FDA, must still approve larger follow-up studies and review that data before authorizing the routine medical use of the drug.

But Rick Doblin, the executive director of MAPS, said he is convinced that will happen — perhaps in five or six years. “MDMA,” he said, “is the most inherently healing of the psychedelic drugs.”

He pointed to the experience of a young Minnesota couple, Shane and Sue Stevens, as an example of how can help people suffering from cancer, and help their loved ones. Their experiences also inspired a key financial donation that got the Marin research project started.

Back in the mid-1990s, Shane, 22, was diagnosed with kidney cancer. He had the kidney removed but the disease had already spread into his lungs. He underwent a brutal regimen of chemotherapy — 23 hours hooked up to the medication, one hour to vomit and shower.

“It started getting ugly between us,” Sue told The Chronicle. “We were really, really stressed. He was dying, and we weren’t dealing with it very well.”

Couple copes with death

That’s when one of Sue’s childhood friends, Tim Butcher, suggested they might find emotional healing by working with a therapist who could get them a drug called MDMA.

Butcher had become involved in the psychedelic underground, and hooked his friend up with a couple of doses of MDMA. Sue and Shane took the drug, sitting on their couch in their apartment, with a therapist available by phone if they needed assistance.

“We started talking about things we had been afraid to talk about, but there was so much love, so much understanding,” Sue said. “I had tears pouring down my face, and all I could do was smile and hug him.”

Sue noticed a complete change in her husband the next day. Suddenly, he wanted to do things again, things he used to love — like mountain biking and in-line skating.

“We started enjoying life — even with the cancer hovering over us. Before we were dreading every day because we were waking up with cancer. Now we were waking up and living life.”

Shane wound up living with cancer for four years. He died on Oct. 2, 1999.

Baby Boomers’ ‘last gasp’

In 2012, at the age of 45, Butcher died of a heart attack. His father, Samuel Butcher, had founded the multimillion-dollar collectables business that makes Precious Moments figurines, the little pastel-colored porcelain statues of big-eyed children living out folksy Bible lessons, so Tim Butcher had a lot of money. He left $1.9 million to MAPS, some of which was used as seed money to fund the Marin study.

“Tim, unbeknownst to me, had put MAPS in his will,” Doblin said. “He was a donor who found value in psychedelics in his own life. What he cared about most were these end-of-life therapies.”

Psychedelics, he believes, will follow a path blazed by marijuana — decriminalization for medical use, followed by eventual legalization.

“The last gasp of the Baby Boomers,” Doblin said, “will be the legalization of marijuana and psychedelics.”