It’s with a sense of gratitude and shared purpose that I’m reaching out to Dr. Bronner’s Heal Soul Blog readers. I am grateful for the long-term strategic and philanthropic support that MAPS has received from David Bronner and the Bronner family, which is made possible by Dr. Bronner’s international community of employees, vendors and customers. The support MAPS has received is pivotal to our ability to gather data on MDMA-assisted psychotherapy for PTSD, and other topics discussed in this blog.
MAPS, Dr. Bronner’s and our communities share an appreciation for the All-One sense of unity that Dr. Emanuel Bronner points us toward. That sense of unity has been catalyzed by psychedelics for thousands of years. While psychedelics aren’t the only catalyst of these experiences of unity, they are one of the most reliable. Wisely used, psychedelics have the potential to help “Heal the Soul”, individually and collectively in our closest relationships, tribes, societies, nations, religions and in humanity as a whole. Yet for historical and cultural reasons, psychedelics are mostly prohibited, though that is gradually changing, especially now with the passage of the Oregon Psilocybin Initiative that Dr. Bronner’s supported in a big way.
I first worked with a PTSD patient with MDMA in 1984,–a woman who suffered a vicious sexual assault. I’ve spoken about this in my TED Talk. I knew from direct experience, before MDMA was made illegal, that it would be remarkably effective for PTSD. I started MAPS in 1986, a year after both the therapeutic and recreational use of MDMA was criminalized.
Throughout MAPS’ 34 1/2-year history, we’ve raised over $100 million dollars in donations, with over $4 ½ million received from Dr. Bronner’s so far and another $6 million pledged over the next 6 years! In December 2014, MAPS started the MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of MAPS. MAPS PBC will conduct our clinical research and, if our research is successful, will sell MDMA by prescription in a manner that maximizes public benefit rather than profit, with all profits going towards MAPS’ mission. Through MAPS PBC, we are seeking over time to supplement philanthropic donations with earned income in order for MAPS to become a sustainable non-profit. MAPS and MAPS PBC now employ about 100 people with roughly 1/3 at MAPS and 2/3 at MAPS PBC.
Strategically, MAPS has focused primarily on conducting FDA-regulated research into MDMA-assisted psychotherapy for chronic PTSD, seeking to Heal the Soul of people who have been deeply traumatized. MAPS’ research with people experiencing PTSD includes the most difficult to treat, those with chronic, moderate to severe, and often complex PTSD. Almost all have tried medications and/or psychotherapies but are still suffering. We even include people who have attempted suicide in the past, though they can’t be actively suicidal.
We use a two-person therapy team, most often male/female but not always with all genders/ nonbinary people welcome. Our therapeutic method is called Inner-Directed Therapy. The treatment manual that describes the therapy is posted on the MAPS website along with our manual for the adherence ratings. The key principle of our therapeutic method is that we support the emergence and expression of thoughts, emotions and bodily energies that are reported by the subject rather than directing the experience with a preset agenda. We hypothesize that the mind has an inner healing intelligence, similar to our body’s self-healing mechanisms, and that MDMA catalyzes an emergence of psychological material in an order and sequence that has an unconscious, emotional logic. Our Inner-Directed Therapy can involve some techniques from other therapeutic approaches but only in response to content emerging from the volunteers. Our lead psychiatrist and first author of the Treatment Manual, Dr. Michael Mithoefer, has written an excellent article, entitled, MDMA-Assisted Psychotherapy: How Different is it from Other Psychotherapy?
To learn more about MDMA-assisted psychotherapy for PTSD, there’s a terrific 90-minute documentary called Trip of Compassion available for a few dollars on Vimeo. It follows the MDMA healing journey of three of our Israeli PTSD subjects, with English subtitles. This is the best documentary ever made about the process of MDMA-assisted psychotherapy for PTSD. There’s also a compelling 13 1/2 minute documentary on the website, The Verge, called Ecstatic States: Treating PTSD with MDMA, focusing on a Vietnam vet whose PTSD was successfully treated by MDMA, and an excellent 7 minute video on the Economist called How MDMA is Used to Treat PTSD, which focuses on an Iraq War vet in our Phase 2 study.
The treatment provided in MAPS’ Phase 3 study takes about 3 1/2 months of therapy during which time the volunteers receive 3 day-long experimental sessions about a month apart, in most cases with overnight stays. There are also 12 90-minute non-drug psychotherapy sessions for preparation and integration, with three sessions for preparation before the first experimental session, and then three sessions after each experimental session for integration. The therapy team works with the volunteer for about 42 hours total. After the therapeutic part of the study is complete, therapy team follows up two months after the last experimental session to assess the volunteer’s PTSD symptoms for our primary outcome measure. During the roughly 5-month process, the volunteers are instructed not to start any new therapies or medications so that any changes in PTSD symptoms would just be from the MDMA-assisted psychotherapy. There is also a 12-month follow-up after the last experimental session to gather information about long-term effects, in part to use with insurance companies to persuade them to cover the costs of therapy for their members.
We ask all people to taper and then stop taking their other psychiatric medications since these could block the full effects of MDMA, reducing the efficacy of MDMA-assisted psychotherapy. It’s a challenge for some people to taper off of their medications since they may be helping reduce some symptoms. The therapists tell people their symptoms might get stronger during the tapering period and we monitor them closely along with their prescribing physician. The therapists also communicate that the tapering process is preparing them for the therapy, which isn’t about suppressing emotions but about becoming able to process emotions.
It can be challenging for some volunteers to accept tapering off their psychiatric medications. They also have to accept that half the subjects will be randomized to receive therapy plus inactive placebo during all of the 3 day-long experimental sessions, and half will be randomized to receive therapy plus active MDMA during all of the 3 day-long experimental sessions. The therapists prepare people for this and indicate that the psychotherapy itself can be effective. They also indicate that the protocol is designed so that once the entire study is concluded, all the volunteers who receive therapy with inactive placebo can go through the treatment again knowing they will receive therapy with active MDMA. For the initial subjects, this could be a year and a half or so after they complete treatment.
Our Phase 2 data, which we collected from 2000 to 2016, demonstrated that in the control group where subjects received therapy without active MDMA, 23% no longer met the diagnosis for PTSD at the primary outcome measure two months after the last experimental session. This is quite good for psychotherapies in this group of patients. In the experimental group, subjects who received therapy with active MDMA, 56%, more than twice as many as in the control group, no longer met the diagnosis for PTSD at the primary outcome measure two months after the last experimental session. Even better, at the 12-month follow-up, people kept getting better on their own and 67% no longer met the diagnosis for PTSD. Of the remaining 1/3 of subjects, most showed clinically significant reductions in PTSD symptoms. If we’d been able to administer a 4th MDMA session, perhaps many of them might also no longer meet the diagnosis for PTSD.
We’ve now completed the first of our two Phase 3 studies (MAPP1) and will know before the end of 2020 whether it was statistically significant. In March 2020, MAPS’ Data Monitoring Committee (DMC) conducted an unblinded interim analysis of the data from our first Phase 3 study when 60% of the subjects had reached their primary outcome measure, and all 100 subjects had been enrolled. The DMC reported great news, that we had a 90% or greater probability of obtaining statistically significant result after all 100 subjects had completed the study, and we didn’t need to add anybody to the study. Shortly after the interim analysis, the Covid-19 lock-down resulted in the halting of treatment for a period of time. FDA reached out to us and other sponsors of research and offered the opportunity to end our studies early. We negotiated with FDA that we would end the study when 90 instead of 100 subjects had one baseline measure of their PTSD symptoms, and at least one outcome measure of their PTSD symptoms after at least one experimental session. While fewer than 100 subjects decrease the likelihood of statistical significance, the outstanding results of the interim analysis suggest that even with just 90 subjects, we have a very good chance of obtaining statistical significance.
On the basis of the great news of our interim analysis, MAPS and the Psychedelic Science Funders Collaborative and Tim Ferriss raised $30 million dollars in multi-year donations to complete Phase 3 for FDA, Health Canada and the Israeli Ministry of Health, as announced in the Wall Street Journal. We’ve already started our second Phase 3 study (MAPP2). If people with chronic PTSD would like to volunteer for the study, or have a friend who might want to volunteer, they can find out where the 14 sites are located (11 in the US, 2 in Israel and 1 in Canada) by going to clinicaltrials.gov and entering MDMA and PTSD in the search fields. The entry for MAPP2 will specify which sites are recruiting and who to contact at each site to start the screening process. We’re seeking subjects who live within an hour or so drive of the study sites.
FDA has also approved MAPS to treat 50 subjects in an Expanded Access/Compassionate Use protocol with another 10 sites to open for screening at various times in 2021. In the Expanded Access protocol, there is no control group since the protocol is for compassionate use. As result, the lack of a control group means that the while the FDA does look at the safety data, it doesn’t consider the efficacy data. Patients need to pay for their own treatment, but MAPS has raised funds to subsidize the treatments of some veterans, BIPOC PTSD patients, or any PTSD patients in North or South Carolina. The Expanded Access protocol is posted on clinicaltrials.gov and each site will be listed once it starts screening If you or anyone you know wants to volunteer and lives within an hour or so drive of any Expanded Access site, we encourage you to start the screening process and also inquire as to whether we have any funds to subsidize your treatment if you meet the inclusion and exclusion criteria for the study and are approved to volunteer. We’re also close to starting a study of MDMA-assisted psychotherapy for eating disorders with sites in Denver, Vancouver and Toronto, with information about this study also to be posted on clinicaltrials.gov.
If the data from our Phase 3 studies prove safety and efficacy, we anticipate FDA-approved prescription use of MDMA-assisted psychotherapy for PTSD in late 2022 or 2023. If our first Phase 3 study turns out to be statistically significant, we’re going to start another $30 million fundraising campaign to support conducting Phase 3 research for the European Medicines Agency (EMA) and to globalize regulatory approvals for MDMA-assisted psychotherapy for PTSD.
We believe that FDA approval of MDMA-assisted psychotherapy for PTSD will be followed by regulatory approvals around the world. Then we’ll see the establishment of thousands of psychedelic clinics with therapists cross-trained in MDMA, and also ketamine, psilocybin, and perhaps other psychedelics as other sponsors obtain approval from regulators. Eventually, there could be a licensed legalization system for adults to legally access psychedelics in a post-prohibition world to take on their own without supervision by therapists.
We anticipate the clinics will initially treat patients with clinical indications. Over time, the clinics will likely also treat family members of patients with clinical indications. MAPS has already sponsored a study blending MDMA with a form of psychotherapy for PTSD called, Cognitive Behavioral Conjoint Therapy (CBCT), where “conjoint” means dyad or couple where one member has PTSD which impacts the other person. In the study blending MDMA with CBCT, both members of the couple or dyad received MDMA. The size of the treatment response in the combination of MDMA with CBCT was larger than in the studies of CBCT without MDMA. Eventually, we’re guessing by 2035, the clinics could become sites of initiation where mentally healthy people could go to have their first psychedelic experience under supervision and then could receive a license to purchase psychedelics to do on their own. If they misbehave under the influence of psychedelics, they could be punished for their misbehavior and could also lose their license to purchase psychedelics for a period of time and be required to participate in additional educational programs. The initial experience in the clinic would be close to free with expenses covered by all the tax income paid by people with licenses purchasing psychedelics.
MAPS’ goal is mass mental health, facilitated by psychedelic-assisted psychotherapy in therapeutic contexts covered by insurance and through drug policy reform leading to legal access to psychedelics outside of therapeutic contexts for adults and access to minors only with permission from their parents or guardians. Our goal is similar to Dr. Emanuel Bronner’s goal of having millions and billions of people experiencing the All-One sense of unity. As Theodore Herzl wrote, and Dr. Emanuel Bronner and family and MAPS believe, “If we will it, it is not a dream.”
You can sign up for the free MAPS Newsletter http://maps.org/newsletter for information about new developments, and to keep an eye out for our upcoming membership program. We’re going to be growing Team Psychedelics to meet the challenges and opportunities ahead.