For the first time ever, with the recent FDA approval, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way.
The Food and Drug Administration recently announced a change of status of the psychedelic compound MDMA for the treatment of post-traumatic stress disorder (PTSD), a move that some researchers see as the first step towards a psychedelic cultural renaissance.
Far removed from its humble origins as a therapeutic tool, MDMA, or Methylenedioxymethamphetamine, has typically been associated with counterculture, “Rave” festivals, and recreational drug use. However, in recent years the atmosphere around the substance has shifted from one of skepticism and scorn to one of curiosity and optimism.
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) — the organization leading the fight for legal MDMA therapy – announced in late August the FDA’s decision to grant “Breakthrough Therapy Designation” to MDMA for PTSD sufferers. The designation means the FDA agrees that MDMA-assisted psychotherapy — which combines psychotherapeutic techniques with three doses of MDMA, will take place with two to four weeks passing between each dose — may have advantages over other PTSD medications.
MAPS also announced that the FDA agreed to the design of two upcoming Phase 3 trials of MDMA-assisted psychotherapy for patients with severe PTSD. The first Phase 3 trial will start enrolling patients in Spring 2018. The goal of trials in Phase 3 is to examine the efficacy and safety of the therapy on 200 to 300 patients with PTSD within the U.S., Canada, and Israel.
Rick Doblin, Founder and Executive Director of MAPS, celebrated:
For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way. … Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”
The long road ahead for medicinal MDMA
Dobin and MAPS have been at the forefront of the fight for psychedelic research for three decades. In 2012, MAPS released a long-term study on the benefits of MDMA in the treatment of PTSD. Due to the work of the nonprofit, MDMA-assisted psychotherapy could be approved as a legal prescription medicine in 2021. However, in addition to a long approval process by the FDA, there are still more bureaucratic hurdles remaining. The FDA must review the application, determine how to label the product, and inspect the manufacturing facility. Finally, the DEA will have to adjust MDMA’s Schedule I status to a lower status that recognizes the drug’s medicinal benefits.
Shannon Clare Carlin, Manager of MAPS’ MDMA Therapy Training Program, served as co-therapist for Phase 2 of the MAPS-sponsored MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. She will be a co-therapist at the Los Angeles site of Phase 3 trials next spring. Carlin, speaking to MintPress News, described the experience of working with three women living with cancer as an honor and a blessing:
“In sometimes unexpected ways I got to be a part of and witness them reclaiming life — overcoming anxiety, trauma, anger, and fear in order to nourish intimate relationships, heal from family hurts, and just be able to have fun. One of the participants was able to face trauma and anxiety that greatly limited her ability to leave the house, drive to work and social gatherings, do things she loved like being out in nature.”
Carlin has worked with MAPS since 2011. She describes the experience of fighting for the ability to study MDMA as akin to a pipe dream. “Well Phase 3 is suddenly around the corner, we are fervently working on details,” Carlin stated. “It’s all about to happen, the biggest MDMA-assisted psychotherapy study yet!”
Psychedelic researchers, advocates, and potential patients have celebrated the FDA’s decision as the latest victory in the fight for psychedelic research, as well as in the larger fight for cognitive liberty. Neal Goldsmith, Ph.D., a psychotherapist and one of the organizers of the annual Horizons Psychedelic Conference in New York, believes the fight to study MDMA and other psychedelic compounds is one battle in the larger war for cognitive liberty.
In a conversation with MintPress, Dr. Goldsmith shared his questions and thoughts about the importance of psychedelics in this larger context:
Cognitive Liberty is a necessary condition as we move forward, but we should think of why we want this cognitive liberty to take psychedelics. Why do we use this liberty to take psychedelics as opposed to any other behavior? Because of the effect. Although cognitive liberty is important, for me as a clinician, as a theorist of psychedelic therapy, the purpose of that liberty in this context is to take psychedelics to grow spirituality, gain maturity, gain wisdom, clarity, to facilitate our development, just like it has been used in rites of passage in tribal settings.”
Over the last decade, the Horizons conference has become one of the top events in the United States for psychedelic researchers, scientists, advocates, and users. Among the speakers at Horizons earlier this month were Philip E. Wolfson, M.D., discussing “Ketamine Assisted Psychotherapy”; Thomas Kingsley Brown, Ph.D., talking about using the psychedelic compound ibogaine to treat the nation’s opioid crisis; and Michael P. Bogenschutz, M.D., speaking about using psilocybin, the active ingredient in “magic” mushrooms, to treat alcohol dependence.
When asked how the atmosphere of this year’s conference differs from years prior, Goldsmith said the tone of the event was optimistic and calls the change gradual, explaining:
“Last year was the 10th-anniversary conference, we looked at where the research was in 2007 and where it will be in 10 years. In 2007 the research was very early, it was a baby could have been smothered by negative politics or regulations. Now 11 years later it’s not so easy to smother, but it’s not fully launched.”
Optimism as research, official response trend positive
As Goldsmith notes, researchers are estimating five to seven years before MDMA and psilocybin are rescheduled by the DEA and can be prescribed by physicians to treat conditions beyond PTSD and anxiety. In fact, Goldsmith says, we are witnessing a race towards approval and rescheduling between psilocybin for treating substance abuse and MDMA for treating end of life anxiety and PTSD.
Research into the benefits of psilocybin has steadily increased in the last decade. In 2006, Roland Griffiths, a psychopharmacologist at Johns Hopkins University School of Medicine, and a team of researchers published a groundbreaking article in the Journal of Psychopharmacology: “Psilocybin Can Occasion Mystical-Type Experiences Having Substantial and Sustained Personal Meaning and Spiritual Significance.” The paper concludes that, “When administered under supportive conditions, psilocybin occasioned experiences similar to spontaneously occurring mystical experiences.” In a 2009 interview with MAPS, Griffiths stated, “The first study showed that psilocybin can, with high probability, occasion mystical-type experiences that appear virtually identical to naturally-occurring mystical experiences which have been described by mystics and other religious figures throughout the ages.” Essentially, Two-thirds of participants in the sessions described them as being among the most meaningful experiences of their lives.
Griffiths’ lab pressed ahead with its work in a 2014 study on the possibility of treating nicotine addiction with psilocybin. Participants had three psilocybin sessions and three cognitive-behavioral therapy sessions to diminish cravings. Eighty percent of those who received the psilocybin treatments abstained from nicotine for over six months, while less than 7 percent of those who received traditional nicotine-replacement therapy were successful for more than six months. Those who reported a “mystical experience” had the most success in breaking their addiction.
For Goldsmith and other psychedelics advocates, such studies point to the importance of introducing these compounds to the mainstream world. “People think this is the psychedelic renaissance but it is actually the research renaissance,” Goldsmith says. “But the actual renaissance of society will only begin once these substances are rescheduled.” He believes these compounds are synonymous with a spiritual sacrament, calling them “the most powerful psychiatric medicine ever created.” He believes the advocates will succeed for the simple reason that “psychedelics are illuminating.”
It remains to be seen when, and whether, MDMA and psilocybin are rescheduled. For the moment, MAPS, Neal Goldsmith, Shannon Carlin, and millions of other psychedelics supporters are hoping they will soon have the freedom to medicate themselves using various psychedelic compounds.
Top photo: A singel dose of medicinal MDMA is shown. (Photo: MAPS)