Summary: The intention and creation of MAPS’ MDMA Therapy Training Program are highlighted in a recent article from Elemental. The article explores the facet of training that includes an optional experimental MDMA-assisted psychotherapy session to provide an opportunity for trainees to learn what the experience feels like from the patients’ perspective. “We needed to have a legal way for therapists to have their own experience,” explains Acting Medical Monitor Dr. Michael Mithoefer.
Originally appearing here.
Ben Sessa was 18 years old in 1990 and working as a DJ in the early days of the London rave scene. “I was very much exposed to ecstasy,” he says. He doesn’t want to discuss the drugs he may or may not have taken back then. But he does admit to taking ecstasy a few years ago, this time for science, and is happy to talk about his trip.
Sessa, now a psychiatrist based in Bristol, U.K., is leading a clinical trial of MDMA, the technical name for the psychedelic, for treating alcoholism. His is one of several ongoing studies investigating whether the main ingredient in ecstasy might help people cope with serious psychiatric issues, such as post-traumatic stress disorder (PTSD), depression, and addiction. He is also enrolled in an MDMA study as a participant. That one is for therapists who are leading trials and who hope to offer the drug alongside therapy for patients with PTSD, substance abuse disorder, or other mental health issues. Sessa is one of a hundred therapists in several countries preparing to prescribe MDMA by trying it themselves — and rewriting our understanding of the power of altered states in the process.
Although MDMA (3,4-methylenedioxymethamphetamine) gained popularity in the 1990s rave scene, the chemical has been around since the early 20th century, after a German drug developer synthesized it by accident for Merck in 1912. The U.S. government briefly toyed with its use in psychological warfare, and psychotherapists suggested it for their patients in the 1970s and 1980s. But soon after people started using it recreationally, the Drug Enforcement Agency (DEA) classified it as a Schedule I drug, making it illegal and more difficult for researchers to study.
TThe notion that altered states could help people working through trauma has a long history. Hypnosis, meditation, trances — all of these capitalize on the mind’s ability to leave ordinary consciousness temporarily and create therapeutic pathways that are normally unavailable. People might talk more than usual, for example. Or they may be less resistant to facing conflict or painful memories. They may feel safer with their therapists. For this reason, many professionals have remained interested in the therapeutic value of psychedelics like MDMA, as well as psilocybin (the active ingredient in “magic” mushrooms), despite their illegality.
The inadequacy of many prescription drugs in helping people suffering from serious issues has also turned some clinicians toward psychedelics. “We didn’t really always have the right treatment for the right individuals,” says Ohio State University social worker Alan Davis, PhD, of his work with combat trauma sufferers. His frustration eventually led him to the Psychedelic Research Unit at Johns Hopkins University, where he currently researches psilocybin for depression.
Psychiatrist Michael Mithoefer became interested in the medical use of psychedelics after witnessing psychological trauma during his years in emergency care. He trained with Stanislav Grof, a Czech psychiatrist known for his research into LSD and other methods of altering consciousness for therapeutic purposes, and eventually became interested in MDMA. In 2001, he developed a clinical trial protocol to study MDMA as a drug to assist therapy for people with PTSD. He is now acting medical director of the Multidisciplinary Association for Psychedelic Studies, or MAPS.
After a three-year review process, the DEA allowed MAPS to use MDMA strictly within the setting of clinical trials that were, in turn, specifically investigating MDMA as a treatment for trauma. (The FDA review took 30 days.) Every new investigation requires FDA and DEA permission and the drug may not be given outside the context of a clinical trial.
MMithoefer knew early on that psychiatrists needed a way to train as MDMA guides. If MAPS trials were to be conducted at multiple study sites, a necessary step toward FDA approval of MDMA as part of PTSD therapy, then he couldn’t run them all himself. Other therapists had to know what kind of environment to provide patients during their treatment sessions, what they might experience, what the side effects might be, and how to assist people with making the best use of their altered-state time. To address that need, Mithoefer began by writing a manual for guiding psychiatric patients through MDMA-assisted psychotherapy, which he posted on the MAPS website. MAPS also established a training program for therapists wishing to lead MDMA sessions, which includes an online course, a weeklong retreat, shadowing an experienced therapist, and some other components.
But something was missing: most of the investigators leading MAPS studies had no idea what ecstasy felt like. “We needed to have a legal way for therapists to have their own experience,” he says. So he created a clinical trial, especially for those who run them.
The current protocol designed for this purpose is a phase I study of up to 120 licensed psychotherapists who have completed the MAPS training program for MDMA-assisted therapy. The investigation, which started in 2011, begins with an online intake session to review informed consent, the individual’s history with psychedelics or other relevant treatments, and current health status, followed by a preparatory phase at the MAPS headquarters in Charleston, South Carolina, or in Boulder, Colorado. After all this, a therapist is eligible for their own firsthand MDMA experience.
Most of the investigators leading MAPS studies had no idea what ecstasy felt like. “We needed to have a legal way for therapists to have their own experience,” Mithoefer says. So he created a clinical trial, especially for those who run them.
That experience consists of two experimental sessions, separated by a day off, with either MDMA or a placebo. Mithoefer and his wife, Annie, a therapist trainer and supervisor at MAPS, serve as the guides for many of the sessions. They check vital signs, ensure the participant’s safety and well-being, and occasionally make suggestions to help the person make the most of their time. Both the participants and the guides are blind to whether a participant has taken MDMA or the placebo, though they must have one session with each.
After both sessions, the participants remain at MAPS for an integration session to discuss their experiences and allow whatever insights they gleaned to seep into their unaltered state. The Mithoefers follow up with several phone calls afterward, asking about side effects — anxiety, fatigue, and headache are the most common — and offering support as participants continue to process their experience.
TThe Mithoefers describe MDMA as “inner directive therapy.” The point isn’t to express the altered state outwardly, but to use the state to confront and explore one’s emotions. Michael Mithoefer explains that avoiding such confrontations is what keeps PTSD going. Many substances numb the fear that leads to avoidance — alcohol is an obvious example. But, says Sessa, they also numb other responses, making the overall effect unconstructive. “MDMA selectively removes fear,” says Sessa. “All the other faculties are there, but things are not scary.”
In November 2018, psychotherapist Veronika Gold traveled to South Carolina for her sessions. Gold had become interested in psychedelics while she was still living in the Czech Republic and wondered if MDMA might offer help to people coping with memories of child abuse and rape. She had relocated to San Francisco for graduate school and entered private practice. After hearing the Mithoefers speak about their MDMA research in 2004, she applied to be a therapist on a MAPS clinical trial. Five years later, they invited her to be a therapist on a study of MDMA for PTSD. “It was my dream,” she says. In 2018, she decided to participate in the therapist study. “I felt it was a crucial part of training and work to have that experience,” says Gold, “to better understand and support the people I will be working with.”
Sessa enrolled in the MDMA clinical trial for therapists in 2016. His session began with a pill made of either sugar or 125 milligrams of MDMA. He lay on a bed, chatty but not obviously in an altered state. He was chilly, so his guides — the Mithoefers — offered him extra blankets. They put on music, checked his pulse periodically, and asked how he was feeling. Eventually, his conversation and behavior made his MDMA-induced state obvious. At about two hours into the session, they offered Sessa a booster dose of 62.5 mg, part of the study design, which he accepted. He talked with his guides. He felt fidgety even though he was relatively still. Music continued to play in the background. At some point, his guides offered him an eye mask and encouraged him to “go inside.”
In the days following Sessa’s session, he began to see therapeutic MDMA as distinct from recreational ecstasy. With the latter, he notes, users tend to party, dance, have sex. In a clinical setting, all that energy goes toward sorting through pain, a process that he found revelatory. Unlike LSD and mushrooms, recreational ecstasy isn’t usually taken for a spiritual awakening. “If more people took MDMA in dark silence,” says Sessa, “I think we’d get higher reports of psychospiritual experiences.”
Gold’s experience was similar. She was at ease with a wider range of emotions than usual, she says. “There was this beautiful healing from inside out happening,” says Gold. And she felt connected to her guides, an aspect of the treatment that she believes will benefit patients. Both she and Sessa also note the importance of the counseling sessions before and after, which Sessa calls “the real strength” of MDMA therapy — and where inexperienced guides offering psychedelics fall short. “Things are left unintegrated,” he says. “It’s not just about taking the drug.”
NNot everyone studying psychedelics thinks that psychiatrists must prepare by tripping. “If you show up at the emergency department and you have a broken leg, does it matter that the doctor has had a broken leg?” says Alan Davis of Ohio State. “I don’t have to have had the same experience as the person in the room.”
Psychiatrists don’t necessarily take antidepressants before prescribing them, and they don’t have to experience the types of trauma their patients have been through, he points out. He says decades of psychotherapy trials have shown that the most important factor in ensuring a positive benefit is a strong rapport between the client and the therapist, regardless of whether the therapist shares the same firsthand experience as the patient. And, he adds, most of the skills required for guiding MDMA sessions should already be in the pocket of any good therapist.
The FDA won’t comment on whether it will require personal dosing experiences as a criterion for future MDMA prescribers because the drug isn’t FDA approved yet. And whatever training may be mandated will have to wait until approval, which is expected by late 2021. “The legal impediments have certainly gotten in the way of this research,” says Davis. (In January 2019, MAPS filed an expanded access application with the FDA that would allow people with PTSD to access this experimental treatment while it’s still under investigation; the FDA has not yet responded.)
If the FDA approves MDMA, its flow into clinics will likely meet a bottleneck as psychiatrists rush to become trained in its use. Davis predicts it could be years before patients can access the treatment once it’s approved. “We’re not going to be prepared with enough trained professionals across the country to actually deliver,” says Davis. When the day of approval comes, the MAPS therapist study participants may end up more prepared than most.