Summary: MAPS Founder Rick Doblin, Ph.D., is participating in a panel discussion on June 22 at the Aspen Ideas: Health, a conference that brings together leaders in healthcare to discuss advances and challenges within the field. Read Doblin’s interview for further details about his presentation including the current culture around drugs in the United States and the FDA-regulated drug development process for MDMA-assisted psychotherapy for PTSD.
Originally appearing here.
Rick Doblin is the executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), which he founded in 1986 and grew into an international psychedelic pharmaceutical company. MAPS, which designs or sponsors psychedelic psychotherapy drug development research, received FDA Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD in 2017, with Phase 3 clinical trials underway and FDA approval anticipated in 2021. He will speak in the 2019 Aspen Ideas: Health program track Sex, Drugs, and Rock-and-Roll.
We caught up with him about advances in psychedelic therapy and the current culture around drugs in the United States.
You’ve been working to develop a new way to treat people suffering from Post Traumatic Stress Disorder using the psychedelic drug MDMA, or ecstasy. How can this drug help people with PTSD?
MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. Significantly, the treatment involves only two or three administrations of MDMA in conjunction with psychotherapy in a controlled therapeutic setting, as part of a 12-week course of psychotherapy. In this treatment, MDMA is not the treatment by itself, but must be administered together with psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.
MDMA is a synthetic compound first patented in 1912, and now off-patent, that is widely recognized for its ability to decrease fear and defensiveness while increasing trust and empathy. It may open a “window of tolerance” in patients undergoing psychotherapy for PTSD, enhancing the effectiveness of psychotherapy. MDMA directly reduces activity in the amygdala, a brain region that helps regulate fear and anger and which is often overactive in PTSD patients. By reducing this activity, MDMA may help people feel less afraid of their traumatic memories, and therefore to be able to share them more comfortably with their therapists. MDMA also stimulates the release of specific hormones, such as oxytocin and prolactin, which occur naturally in the human body and are associated with feelings of trust, bonding, and intimacy. Due to their trauma, PTSD sufferers often isolate themselves, or have difficulty trusting their therapists enough to adequately process their emotions. MDMA may facilitate the psychotherapeutic process by helping people feel safer and more connected to themselves and to their therapists. MDMA also enhances activity in the prefrontal cortex, facilitating memory and attention. This is related to MDMA’s effect of stimulating serotonin and dopamine release in the brain.
In MAPS’ completed Phase 2 trials with 103 participants, 56 percent no longer qualified for PTSD after treatment with MDMA-assisted psychotherapy, measured one to two months following treatment. At the 12-month follow-up, 68 percent no longer had PTSD. Most subjects received just 2-3 sessions of MDMA-assisted psychotherapy. All participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.9 years. The combined analysis of all these Phase 2 results was published on May 7, 2019 in the peer-reviewed Journal of Psychopharmacology.
Why would someone choose to be treated for mental illness with psychedelics rather than other prescription medications?
To be clear, existing prescription treatments for PTSD can and do work at least a little bit for some people. It’s just that for many people, they don’t. The volunteers in our Phase 2 trials were all people with chronic, treatment-resistant PTSD, so they’d all tried existing treatments and they hadn’t worked for them. When MDMA-assisted psychotherapy is approved, however, it will be available for anyone for PTSD, not just for treatment-resistant patients.
I think that the main contribution that psychedelic therapy will make to psychiatric treatment is to provide an option for treating mental illness that only involves a very limited course of treatment, and a very limited number of administrations of the drug. Current psychiatric treatments for PTSD involve taking drugs every day, for months or years or forever, in order to keep the symptoms of the illness under control. PTSD sufferers often relive their traumatic experiences through nightmares and flashbacks, have difficulty sleeping, feel detached from daily life, have lower quality of life, and suffer from anxiety, depression, and suicidal thinking. Existing treatments just keep those symptoms in check, and patients have to deal with the side effects all the time. We’re seeing that MDMA-assisted psychotherapy, on the other hand, can get at the root of PTSD, allowing people to re-shape their relationship to their trauma at a deeper level.
More than three dozen states have legalized either medical or recreational marijuana. How is the increasing availability of marijuana affecting your work, if at all?
Legal and regulated availability of marijuana in the United States first appeared in 1996 with California passing Proposition 215, allowing medical use. At the time, public support for legalization was around 25 percent. With demonstrated therapeutic benefits and excellent safety profile observed in medical marijuana patients, public support started to trend upwards reaching majority in 2013, and was recorded at a record high of two-thirds in 2018. Ironically, marijuana is still classified as a Schedule 1 controlled substance by the US Drug Enforcement Administration (DEA), a category for drugs with no accepted medical use, lack of accepted safety use, and high potential for abuse. Since the 1980s, policies and rhetoric have vastly exaggerated many risks of recreational drugs, and minimized potential benefit with an abstinence-only education & policy approach, resulting in a lack of reliable information regarding safety and reducing potential harms, and barriers to conducting research including inadequate quality and supply of study drug as well as lack of funding for studies assessing therapeutic benefits. More research is needed to thoroughly explore the potential risks and benefits of marijuana and psychedelics. Public support for access to previously stigmatized therapeutic tools like marijuana and MDMA has increased drastically over the last decade as medical access and regulated clinical trials have been allowed to take place.
While marijuana is becoming legal, opioids are increasingly stigmatized. How would you characterize the current environment around drugs — socially and politically — in the United States? How does it impact the work you do?
The alarming rates of deaths related to opioid use is a crisis very much in the forefront of political discourse in the United States. Politicians and their constituents are realizing that the so-called “war on drugs” and its draconian, prohibition-based policies have failed to address the issues of unregulated drug trafficking and use, as they are not rooted in public health and safety. For example, psychedelics and marijuana are classified as Schedule 1 controlled substances as the result of explicit political efforts to target political opponents and racial and ethnic minorities. Stigma is one of the primary drivers of drug-related harms, so I am interested in moving away from prohibition-based policies towards more compassionate and human-centered drug policy that regulates and decriminalizes drugs, including psychedelics. When a prohibition-based, zero-tolerance position is taken with regards to drug policy, especially for substances that have the potential to cause physical or psychological harm when not used in the proper setting or with appropriate preparation and supervision, there is a heightened probability of associated harmful outcomes. Conversely, when a harm reduction, education-based position is taken with regards to drug policy, people are equipped to make informed decisions about when and how they use drugs, based on accurate information about the benefits and the risks associated with substance use.
You’d like to eventually become a legally licensed psychedelic therapist. What would need to change, legally, for you to step into such a role?
MAPS is currently working to make MDMA legally available for use in therapeutic settings. We are now conducting the clinical trials needed for the Food and Drug Administration (FDA) to approve the use of MDMA combined with psychotherapy for the treatment of PTSD. In November 2018, MAPS, through its wholly owned subsidiary MAPS Public Benefit Corporation, began Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD at 15 sites in the US, Canada, and Israel. Provided the results confirm the Phase 2 trial results, doctors may be able to legally prescribe MDMA for use in psychotherapy, not as a take-home drug but only for use in controlled therapeutic settings, by 2021. On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. I am excited that after more than three decades of work towards this goal, it’s looking very hopeful that I’ll be able to fulfill my dream of becoming a legal psychedelic therapist—before I’m too old to change careers!
You will speak in the Sex, Drugs, and Rock-and-Roll program track at Aspen Ideas: Health. Can you give us a brief idea of what you’ll focus on in Aspen?
In my talk in Aspen, I’ll discuss the current state of the so-called psychedelic renaissance taking place across the globe and associated political and cultural influences so people can have an idea of the big picture of the potential these substances have for mental health care and beyond. Then, I’ll discuss the FDA-regulated drug development process for MDMA-assisted psychotherapy for PTSD and the results of the clinical trials sponsored by MAPS, as well as the treatment approach and training program for providers. Finally, we’ll turn towards the future and explore what regulation of MDMA-assisted psychotherapy might look like post-approval from the FDA, the availability of treatment in the US and globally, and my vision for a post-prohibition world.