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Molly Jaben

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mjaben@unca.edu

The experience starts the same for most people. The jaw begins to tighten, the stomach becomes jittery, a wave of slight nausea hits, followed by intense, yet delightful, euphoria. Colors shine brighter, sounds become pleasantly exaggerated and touch feels extraordinary. Stand in the crowd at almost any concert or club and you will see party-goers dancing and smiling, all due to one of the fastest growing fads in the nightlife industry, MDMA.

Most have heard rappers brag about “popping Molly” or are familiar with the elusive but tantalizing drug known as ecstasy. Yet, many people remain unaware the famous party drug has humble roots in psychiatry.

In fact, as of August, the FDA granted MDMA-assisted psychotherapy as a breakthrough therapy designation for treatment aimed at reducing the agonizing effects of Post-traumatic Stress Disorder.

According to the U.S. Department of Veterans Affairs, about 7.5 percent of American adults suffer from the disorder.

They also estimate 11-20 percent of Iraqi war veterans suffer from the disorder while 30 percent of Vietnam veterans experience persistent PTSD throughout their lifetimes.

The Veterans Affairs hospital in Asheville knows this all too well. As one of the highest rated VA hospitals in the nation, they service over 38,000 veterans from 20 counties around Western North Carolina, according to official government rankings.

According to the annual budget briefing, the U.S. government granted the VA $7.4 billion worth of resources for mental health treatment in 2016. The VA currently requests an additional one billion dollars to cover the mounting costs of treatment throughout 2018. The budget also predicts an increase of almost 1 million veterans seeking health care through the Department of Veterans Affairs in 2018.

Typically, patients suffering from PTSD receive psychotherapy along with a prescribed SSRI or antidepressant, like Zoloft, Paxil, Prozac and Effexor according to treatment guidelines published by the U.S. Department of Veterans Affairs. However, even these therapies have relatively low success rates. According to data from the Multidisciplinary Association of Psychedelic Studies, more than 80 percent of patients still qualify for a PTSD diagnosis after traditional treatment.

German company E. Merck received the patent for the drug MDMA in 1914 to aid in the development of other therapeutic agents, according to a report by the United States Sentencing Commision.

Alexander Shulgin, a medicinal biochemist hailed as the father of MDMA, introduced the drug to America after synthesizing the compound while working for Dow Chemical in the mid-’60s.

In the ‘70s Shulgin introduced MDMA to his friend Leo Zeff, a psychologist who went on to pioneer psychoactive drug assisted therapy. Zeff ingested the compound, recognized its potential and began administering the drug to patients.

“When it started getting really popular I actually went and talked with a bunch of therapists who used it in therapy and became convinced that they weren’t crazy, that this really was a drug that had a future for psychiatry,” said David Nichols, a medicinal chemist who synthesized MDMA for Zeff’s clinical trials.

By 1980, MDMA infiltrated the nightlife scene across America. The U.S. government, who had created and passed the Controlled Substances Act in 1970, began a series of hearings to determine how to schedule the drug. Many psychiatrists and clinical researchers came forward to provide testimony about the benefits of the psychoactive substance.

In May, 1985, the U.S. government held an emergency scheduling of MDMA, marking it as a Schedule I drug overnight. A Schedule I substance is defined as a drug with no accepted medical use with a high potential for abuse, according to the Drug Enforcement Administration.

“They passed the emergency scheduling because they wanted to. Because there was so much recreational use. The recreational use was getting in the media. It was exploding and it was completely uncontrolled,” said George Greer, a psychiatrist who worked alongside Nichols and testified for the benefits of MDMA.

Advocates of the drug continued to fight for it to be Schedule III or even IV. A Schedule III drug denotes a moderate to low potential for dependence, like codeine or ketamine. A Schedule IV drug suggests there is a low potential for abuse and low risk of dependence, such as Valium or Xanax, according to the DEA.

In fact, Francis Young, an administrative law judge, ruled in 1986 MDMA should be designated as a Schedule III drug. However, on February 22, 1988 the courts reversed this ruling and cemented MDMA as a Schedule I drug.

Moving Forward with MDMA Research

In an effort to fight the scheduling, scientists came together to initiate several organizations designed to acquire funding to continue clinical research of MDMA. Rick Doblin, an advocate for MDMA with a Ph.D. in public policy from Harvard’s Kennedy School of Government, founded the Multidisciplinary Association for Psychedelic Studies.

“Our main priority (at MAPS) is MDMA-assisted psychotherapy for PTSD and that program is the farthest along of anybody in the world in terms of gaining regulatory approval for a drug that’s already currently criminalized,” said Merete Christianson, Doblin’s assistant at MAPS.

(Graphic courtesy of MAPS)

The recent breakthrough therapy designation allows MAPS to begin the third phase of clinical trials for MDMA-assisted psychotherapy with patients suffering from PTSD. The results are astounding, with a reported overall PTSD remission rate of 66.2 percent during the second phase of clinical trials, according to the proposed design for the third phase of clinical trials.

Innovative treatment does not stop there.

Ben Sessa, a research fellow at Imperial College in London, currently heads a revolutionary pilot study for MDMA-assisted psychotherapy and alcoholism.

“Our theory is that high levels of trauma are associated with alcoholism, so we’re using MDMA assisted psychotherapy to see if that can make any improvement in treating alcoholics,” said the 45-year-old adolescent and addiction psychologist.

Current medicinal technologies for alcoholism are poor, with a 90 percent relapse rate three years after detox, Sessa said.

“You know working in psychiatry, the medicines we have are poor. There’s not really been any new medical pharmacology for about 75 years. We’re pretty much stuck in the same rut, which is maintenance therapies. They don’t cure the patient. They just paper over the cracks and treat the symptoms of the disease,” explained Sessa over Skype.

According to Sessa, researchers remain excited about the potential of MDMA’s unique receptor profile. The drug works on several receptors including the serotonin receptors where it reduces anxiety and depression while causing a positive mood and a very mild state of altered perception. The stimulation of dopamine, via amphetamine, enhances the patient’s motivation to engage in therapy while at the same time, paradoxically, relaxing and slowing the patient down, preventing the hypervigilant effects that accompany PTSD. Along with this, comes the release of oxytocin which causes an increased sense of bonding and empathy.

“You work with people who have spent the whole of their adult lives doing anything but think about that traumatic thing that happened to them and as a result they develop addictions or they self harm or they attempt suicide,” Sessa said. “So what MDMA does is remove the fear response that goes with recall of those memories so you can ask the patient to be with and dwell on and talk about and reflect upon these awful painful moments of their past. In that way it provides this kind of bullet proof vest sort of a flotation device that keeps them floating and allows them to do the trauma work.”

However, he notes some major roadblocks in the understanding of this type of assisted therapy. For instance, he illustrates no medical intervention is 100 percent safe. But there have been no deaths in a clinical setting and the mortality rate remains low when considering the high level of recreational use of the drug. Beyond that, funding for clinical research remains difficult to come by. In fact, Sessa’s pilot study is completely funded by a private donor.

“Drugs like MDMA, nobody owns these drugs, they are off patent, nobody can patent the drug, it is in the public domain if you have a license. You take MDMA twice and then you are better and you don’t need to sit on an SSRI for the rest of your life. So who’s going to throw millions of research money at a drug that isn’t owned by anyone and you only have to take twice and then you don’t need it again,” Sessa said.

Sessa and his American colleagues predict MDMA will be licensed around the world by 2024. Unfortunately, MDMA-assisted psychotherapy is not yet available in North Carolina.