Author: alli

How to Become a Psychedelic Therapist

How to Become a Psychedelic Therapist

photo courtesy Harry Quan

As recent trials of psychedelic-assisted psychotherapy enter the last phase of testing, the coming need for many trained therapists and guides seems inevitable. Until recently, the only opportunity to train and work legally as a psychedelic therapist was in clinical trials. That will likely change over time as expanded access becomes the next step for current trials (evaluating MDMA and psilocybin) and if psychedelic-assisted therapies become FDA approved.

Many people are looking for information about psychedelic therapy and opportunities to become guides or therapists after reading Michael Pollan’s new book How to Change Your Mind: What the New Science of Psychedelics Teaches Us about Consciousness, Dying, Addiction, Depression, and Transcendence [1]. Providers are seeking trainings to become more informed about psychedelic experiences. They also want to know how to become certified to administer psychedelics in clinical trials and potentially post approval.

Still, there remain many unknowns about what training programs outside of the drug sponsors will be acceptable by FDA to dispense MDMA or psilocybin post-approval. FDA has never regulated psychotherapy, but medical devices often require training in a certified program. Demonstration of competency and maintaining of the acquired skills is required for compliance with regulatory agencies. Transcranial magnetic stimulation is one example of a specialized device with specific training requirements. It’s not yet known how FDA will regulate trainings for psychedelic-assisted therapies.

When Can I Offer Psychedelic-Assisted Therapy?

The FDA may approve MDMA for PTSD treatment as early as 2021, as MAPS has projected based on an optimistic (and likely realistic) finding of significant and positive results from two on-going Phase 3 trials. If so, thousands of therapists and doctors will be needed to meet the increased demand and opportunity for greater access. PTSD can be a difficult to treat condition with many individuals not accessing or responding to available treatments, so this call for expanded access will be an exciting opportunity to provide care to a much larger number of people who are currently suffering.

The next likely candidate for FDA approval after MDMA is psilocybin for the treatment of depression. In late 2018, the FDA granted Breakthrough Therapy designation for psilocybin for treatment-resistant depression, which will help expedite its approval as long as results from clinical trials remain positive

What are the Options for Training in Psychedelic-Assisted Therapy?

Despite many unknowns, some training programs already exist, and many more are expected to become available.

In 2015, the California Institute of Integral Studies (CIIS) started a formal training program called the Certificate in Psychedelic-assisted Therapies and Research. The hybrid residential, in-person and online curriculum is a roughly 9-month course with rotating guest lecturers and a weeklong retreat. This program is broad in focus, interdisciplinary, and covers classic psychedelic medicines (e.g., psilocybin, ayahuasca, peyote, LSD) as well as the newer medicines (sometimes labeled empathogens or entactogens) like MDMA and ketamine.

To enroll in the CIIS certificate program, interested individuals must fill out an application, complete an interview, and receive an offer from the program’s selection committee. Applicants are required to be a licensed mental health or medical professional, counseling attorneys, or ordained or commissioned clergy and chaplains. The tuition cost is currently set at $10,000. There are several information sessions scheduled throughout the year to explain more and answer questions about the program. Each cohort generally starts in the Spring and graduates in December.

More substance-specific trainings also exist. In anticipation of Expanded Access approval, the Multidisciplinary Association for Psychedelic Studies (MAPS) has now posted an application for the MDMA Therapy Training Program with an invitation to apply. Training is currently prioritized for providers who would likely qualify for the Expanded Access program. If accepted by FDA, more clinics will open for MDMA-assisted psychotherapy for PTSD treatment during expanded access. Requirements for clinics and providers are provided as is a forum for providers to connect with others who are interested in starting up MDMA clinics.

While no strict criteria have been released about who would qualify, the MAPS website states that at minimum one person in the therapy team pair must be licensed to conduct psychotherapy. While the other person does not need to be licensed, they “must display training in therapeutic relationship, ethics, and traumas.”

Each clinic also needs a Drug Enforcement Administration (DEA) license, which requires a licensed medical provider who can prescribe (e.g., medical doctor (MD), doctor of osteopathy (DO), or other eligible prescriber). MAPS encourages interested providers to apply now in preparation for the expected post-FDA approval. The cost for training and supervision is currently set at $9,000.

Other industry drug sponsors, such as Usona Institute and COMPASS Pathways, and researchers at various universities have devised their own trainings and ways to prepare clinicians to work on clinical trials of psychedelics. At this time, there are no details posted on websites about what the trainings consist of, but journal publications have described procedures, such as the Usona Guide Manual [2].

What Do You Learn in the Training Programs?

The CIIS program is approximately 180 hours and covers a wider range of topics related to psychedelic therapies. More time is spent on historical and philosophical aspects of non-ordinary states of consciousness, including non-substance induced ones as seen in Holotropic Breathwork and deep meditation. The learning objectives are focused more broadly on psychedelics and empathogens, rather than specifically on MDMA-assisted psychotherapy [3].

The MAPS program is a 5-part course with didactic training and experiential learning components. Trainees start with online e-learning modules covering MDMA pharmacology and its clinical safety profile, an introduction to the MDMA Treatment Manual [4], and some basics about clinical trials. A week-long, in-person training follows where MDMA session videos are viewed and discussed with the therapists who treated the study participants. The next parts involve role playing, observing MDMA sessions, and then treating a patient with supervision and evaluation from the trainers.

Some parts of these two programs overlap significantly. For example, the weeklong in-person retreat for both programs focuses on MDMA-assisted psychotherapy and are taught by Michael and Anne Mithoefer, MDMA study therapists and lead instructors at MAPS.

What are the Experiential Learning Components of Trainings?

Dating back to the first research studies of LSD in the 1950s, a first-hand experience in a non-ordinary state of consciousness has been perceived valuable for administering psychedelics. It’s thought that by understanding the drug effects, the therapists can more readily establish empathetic rapport and presence to support a person’s therapeutic process. They can also be better able to respect the power and significance of these experiences.

For indigenous communities, it’s deemed essential that shamans or ceremonial leaders have personal experience with the psychoactive plants they give to others. But in Western medical practices, it is rarely the case that doctors are encouraged (or even allowed) to take a medication to understand the effects a patient would feel.

Thus, psychedelics present a new challenge for psychiatric medical training. If there is value in having a personal experience, then how can providers legally pursue an experiential learning component to their training? To date the evidence of potential benefits of doing so remain anecdotal due to lack of approved controlled research.

CIIS’s program is an “above board” program with no use of illicit substances. MAPS, however, received approval in their sponsored, FDA-approved study that allows trainees in their program to receive one dose of MDMA in a clinical setting if they also are eligible for the research study as a participant. As with all clinical trials, participants in the approved study must meet criteria to enroll and provide data to assess potential benefits or harms. Even if they meet the basic inclusion criteria, trainees are not required to undergo an MDMA session. Some might have conditions that would counter-indicate the use of MDMA. For example, pregnant women or individuals with cardiac disease would be excluded. Trainees may also simply not want to take a drug.  

As alluded to earlier, Holotropic Breathwork is one alternative to reach a non-ordinary state of consciousness without consuming any substance. Through accelerated breathing and stimulating music, a person can enter into states similar to ones induced by drugs.

CIIS incorporates Holotropic Breathwork as experiential learning in their program. Therapists may consider alternatives, but they should do so while considering carefully the legal and ethical guidelines of their licensing board and professional organizations. Psychedelic Support and its partners do not encourage or condone the illegal use of substances.

Given this reality, other possible alternatives for experiential learning do exist. They include attending plant medicine ceremonies in other countries where it is legal, shamanic drumming/chanting practices, or extended meditation. Research is needed to understand if first-hand exposure by therapists impacts patient outcomes, and if so, what type of drugs or experiences are best for training. We encourage therapists exploring this new area to consult with their colleagues and even seek out legal counsel as they deem appropriate.

What Can I do Now?

If becoming a psychedelic therapist is of interest to you, then there are things you can do now to help figure out if this path is right for you and if so, prepare for the future. You can start by reading books and articles about psychedelic-assisted therapies. If you want hands-on experience supporting individuals undergoing a difficult psychedelic experience, one great way to do so is to volunteer for harm reduction services at festivals.

Already a health provider? Network with other professionals interested in this topic and attend psychedelic conferences. If you are a clinician, consider joining a Psychedelic 101 and 102 Introductory Course by Psychedelic Support providers, Dr. Elizabeth Neilson and Dr. Ingmar Gorman. Check out our website Psychedelic.Support to view a current list of organizations offering professional trainings related to psychedelics.

Lastly, educate yourself and share what you are learning with others. A new profession is evolving, and more opportunities are becoming available for those who wish to pursue a career in psychedelic medicine.

References

  1. Pollan, M. (2018). How to change your mind: what the new science of psychedelics teaches us about consciousness, dying, addiction, depression, and transcendence. London, United Kingdom: Penguin.
  2. Cooper, K. (2014). Guide manual for pharmacokinetics of psilocybin in healthy adult volunteers study (Unpublished manuscript). University of Wisconsin, Madison.
  3. Phelps, J. (2017). Developing guidelines and competencies for the training of psychedelic therapists. Journal of Humanistic Psychology, 57(5), 450-487.
  4. Mithoefer M. (2017). A Manual for MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder. Multidisciplinary Association for Psychedelic Studies, Version (8.1).
Kile Ortigo, PhD
Kile Ortigo, PhD is a clinical psychologist. Find out more about Kile's integration and mental health services on his profile page in the Psychedelic Support Network.
Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.
Can We Quantify the Placebo Effect in Psychedelic Medicine?

Can We Quantify the Placebo Effect in Psychedelic Medicine?

Here, take these pills. It will make you better. Likely you’ve heard these phrases before if you’re living in a medicalized society. For whatever ails you, there is a pill or an entire arsenal of medications that your doctor may prescribe.

Some of these drugs are life-saving remedies with biological targets that interrupt disease progression or kill infectious bacteria. But some of the most effective pills for certain chronic conditions, carry formulations of inert material, commonly known as a placebo.

Repeatedly documented, the phenomenon of a ‘placebo effect’ describes symptom improvement or even full recovery after taking pills or treatments that have no known biological activity. The placebo effect also refers to a positive response that surpasses what can be explained by the intervention alone.

Psychedelics clearly have potent effects on the brain and psychological processes. Accumulating research is showing that psilocybin and MDMA can be paired with psychotherapy to alleviate treatment-resistant depression and posttraumatic stress disorder (PTSD). The results from these trials are phenomenal and how these drugs boost therapy is a question to be unraveled.

While there are presumably several mechanisms at play, the placebo effect likely plays some role in psychedelic medicine. Can we quantify how much of the outcomes are related to placebo effect? Can we gain a better understanding of how these processes work in order to amplify improvements even more? Possibly.

The power of believing: placebo and nocebo effects

So what is happening in double-blind experiments when both the patient and the doctor are not told whether the patient receives an inactive substance, like a sugar pill, or the active test drug. In adequately designed studies with sufficient blinding, the same set of instructions and procedures are followed for all patients, regardless of the group assignment (placebo or active drug).

If there is a true effect of the investigational drug a statistical difference between groups will emerge, yet in many studies there is some number of participants who present a ‘placebo response’ – positive outcomes, often times equivalent to those that received the actual drug.

The notion that this could be spurious data points of outliers or spontaneous remission of symptoms is debunked by the fact that placebo responses are consistently replicated, especially for certain conditions associated with chronic pain, stress, and anxiety.

The placebo response is a variable that can be manipulated. How and by whom a treatment is administered can impact a patient’s response. For example, a study showed that patients given a skin cream by a distant and distracted doctor faired far worse than the same cream applied by an attentive and competent doctor.

Expectation is another factor that has pronounced effects when manipulated in clinical trials. Simply telling a person that the drug they will receive has helped others with a similar condition can shift responses in the positive direction.

Research has identified a neurochemical basis for not one, but many placebo responses. The most well characterized placebo effect is activation of the endogenous opioid system by the release of endorphins that can knock down pain severity.

Placebos can also cause dopamine release that fires up the reward pathway and reduces anxiety by suppressing the amygdala. These mechanisms explain, at least in part, why placebos can be quite effective for treating certain types of pain and anxiety-related conditions.  

Psychological factors, or how a person perceives a treatment, also influence the response. The power of suggestion and the magic of believing are psychological constructs with measurable outcomes in performance and body functioning. It’s not always that responses are shifted in the positive direction. Expectations or thinking that a treatment won’t work can result in the opposite direction, known as the “nocebo effect” or worsening of symptoms.

The idea that thought patterns can mediate seemingly independent physical processes shows up in other spheres of biohacking and transcendent experiences. Take for example neurofeedback, where a person can learn to moderate heart rate, breathing, and skin conductance by practicing with audio or visual cues to tune brain firing patterns that control these physiologic functions.

How we think and what we imagine can have powerful consequences on how our bodies function.

Psychedelics persuade us

What about psychedelic substances being used for treatment of mental health conditions? By definition, these drugs possess qualities to alter conscious perceptions of self and the material world. There are felt experiences that validate what the user has read or been told. Combine this with a therapeutic environment tailored to amplify the experiences psychedelics invoke, it appears the perfect stage has been assembled for the placebo effect to come into play.

Set and setting are often referred to when talking about psychedelics. The person’s internal state and the external environment are critical variables in how the psychedelic experience unfolds.

In psychedelic clinical trials, bleak clinics are transformed into aesthetically pleasing living room like settings that bring in elements of nature and sensory-enhancing musical and visual stimuli. Two guides or therapists are always present, offering an empathetic ear and support in whatever ways are needed. In these carefully manufactured environments, deep healing can occur, and the belief that it can, surely propels the therapeutic effects.

One of the guiding principles in MAPS MDMA Therapy Treatment Manual is talking to participants about their “inner healing intelligence”. The manual says to convey this concept to study participants by describing that similar to how a doctor can set conditions for healing to occur by cleaning and bandaging a cut to the skin, the body is responsible for the actual healing to occur. Creation of new skin cells and the fabrication of tissue layers occurs largely through unconscious processes of the physical body, and not from a doctor waving of a magic wand. So too, is the case for emotional healing. The power to heal comes from within and every individual possesses it.

In the case of MDMA-assisted psychotherapy, the role of the therapists and the drug is to help the person activate this inner healer and support them in the healing process which can be painful and challenging. Same for a laceration to the arm, tenderness and discomfort are intrinsic in path to healing.

During the preparatory sessions prior to taking MDMA, the seed has been firmly planted that self-directed uprooting of internal resources can and should be pursued in the drug-assisted sessions. Is it possible that this “inner healer” has a neurochemical basis? Does it overlap with recognized mechanisms of placebo effects? MDMA releases dopamine in the reward pathway in the brain, as do placebos. Perhaps there are synergistic effects of drug- and placebo-stimulated release of neurochemicals, the sum being greater than either on its own.

Drug effects vs. placebo reponse

It appears that psychonaunt guidebooks and clinical trial protocols tap into many of the variables known to impact the ‘placebo response.’ Leading one to ask, is it possible to delineate how much of the reported outcomes for MDMA and psilocybin are due to biological drug effects or from placebo effects?

Current trials are not designed to evaluate this question. Even though the studies randomly assign participants to receive active drug or a placebo, or even an active placebo where some minimal psychoactive effects may occur, the fact that the majority of participants and therapists can easily recognize the psychoactive properties limit interpretation of results because they suspect with good certainty that they received the drug, or not.

A simple subtraction of blinded psychedelic drug group response minus placebo group response won’t give the true effect because of the confounded blind. Add to that the media reports that these substances are panaceas for all aliments of the mind-body continuum, its undeniable that implicit bias must exist.

But perhaps an even more relevant question to ask is whether or not it even matters if some degree of the positive changes we observe after psychedelic treatments are due to amplification of the classical “placebo response”? Mega dollars have been invested by large pharmaceutical companies to understand how to minimize the placebo response to more easily pass drugs with minimal efficacy into FDA approval.

Perhaps the alternative approach of maximizing the psychological processes already at work to promote greater and faster recovery is worth investigating more. Manipulating the environment and the information given to participants in clinical trials of psychedelic therapy could help us learn more about the psychological factors involved.

As more information is generated, who knows we may find that psychedelics can strengthen the effects of other drugs or therapies by a common pathway converging on our innate ability to consciously heal ourselves.

Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.

Healing Trauma with MDMA: A New Study Published

Healing Trauma with MDMA: A New Study Published

Patchwork Art from MAPS Therapist Training Program 2017

Photo Credit: Alyssa Gursky

Findings from the last study in a series of six Phase 2 trials of MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD) was published today in the Journal of Psychopharmacology [1]. The clinical trial in Boulder, Colorado (MP-12) enrolled 28 participants suffering from chronic PTSD. Results showed that after two to three sessions of psychotherapy with active doses of MDMA (100-125 mg) PTSD symptoms were markedly reduced. Twelve months later most participants (76%) did not meet criteria for PTSD.

 After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.

 

Marcela Ot’alora G.

Principal Investigator Boulder, CO

Decades in the Making

The Multidisciplinary Association for Psychedelic Studies (MAPS) was founded in 1986 with the intention to take MDMA through the FDA-regulated drug development pipeline. The non-profit organization faced many political and logistical hurdles to research MDMA, a schedule 1 controlled substance. The first randomized, blinded study investigating MDMA-assisted psychotherapy started in 2000 in Spain by MAPS. After treating six women survivors of sexual assault with no serious adverse effects and PTSD symptoms on decline, the study was suddenly halted due to political pressure from the Madrid Anti-Drug Authority in 2002 [2].

Marcela Ot’alora G., MA, LPC was a psychotherapist in this first study. A decade later in 2012 she became the first woman Principal Investigator for a MAPS-sponsored trial in the US. She trained and supervised nine therapy teams for the trial in Boulder, and treated 17 participants as the lead psychotherapist. Importantly, the positive results from this study showed that new therapy teams could replicate findings from previous studies (MP-1 [3], MP-8 [4]) that had a single therapy team – Michael Mithoefer, MD (Psychiatrist) and his wife Annie Mithoefer, BSN (Psychiatric Nurse). It was uncertain if interns and newly trained therapists would be able to produce significant results equivalent to the very experienced and compatible Mithoefer team.

Photo: Marcela Ot’alora G. and Bruce Poulter at their home in Boulder, CO. 

Marcela rotated amongst teams, pairing with her husband Bruce Poulter, MPH, RN to treat several participants. Six other therapists worked on the study, including Dr. Will Van Derveer, MD, ABOIM who acted as study physician and therapist, and is now a provider in the Psychedelic Support Network. Sara Gael Giron, MA, Director of MAPS Zendo Project, treated three participants and currently works in Boulder with Dr. Van Derveer at the Integrative Psychiatric Healing Center.

In the study publication, results were presented for both the intent-to-treat set, which refers to  the group of participants who completed at least one MDMA session, and the per protocol set, which included only participants who completed both blinded MDMA sessions and matched all criteria for being in the study. It was discovered during the study that three participants had mental health disorders that made them not meet all study criteria, thus they were excluded from the per protocol analysis.   The main measure of PTSD symptom severity was change in the Clinician Administered PTSD Scale (CAPS-IV) from baseline to one month after the second blinded MDMA session. During blinded sessions, participants were given MDMA at doses of 40 mg (active placebo), 100 mg or 125 mg (active doses). Before and after MDMA sessions, participants underwent non-drug therapy sessions for preparation and integration.

 

PTSD Symptoms Improve

The 100 mg and 125 mg doses had a medium to strong effect on PTSD symptoms, but only the per protocol set reached significant group differences at this point. Principal Investigator Marcela Ot’alora G. commented, “The results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma”. At this point, a month after both blinded sessions, participants learned what dose group they were in. Participants given 100 and 125 mg had a third open label session, and participants given 40 mg started a new, second part of the study, or a “cross-over” where they had three open-label MDMA sessions.

PTSD symptoms, including anxiety, sleep disturbance, and depression, continued to significantly improved after the third active dose session for the 100 mg and 125 mg group. The 40 mg group showed similar reductions in symptoms after they crossed over and had three open-label sessions with 100-125 mg MDMA. In the paper, the authors describe how the treatment is effective by saying, “an enhanced therapeutic alliance combined with reduced anxiety or discomfort around difficult memories, increased self-compassion, and openness to expanding meaning of thoughts, feelings or experiences may all contribute toward therapeutic effects.” [1]

An impressive finding from this study was the PTSD symptom (CAPS-IV) scores 12 months after completing treatment. Upon enrolling in the study, the average CAPS-IV score was 92, and at the 12-month follow-up, had decreased to 31. At 12-months, 76% of participants (n=25) did not meet criteria for PTSD.

“After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges” explained Marcela.

The average CAPS-IV (or PTSD symptom) score dropped 9.6 points from treatment exit to 12-month time point, demonstrating that MDMA therapy not only produced enduring reduction in PTSD symptoms but allowed for continued healing and growth long after the drug-therapy ended. With PTSD symptoms no longer interfering with emotional and cognitive processes, the participants were able to re-integrate into life and recover from PTSD. “What we see after reprocessing of memories and feelings,” says researcher Dr. Lisa Jerome, “is not only reduction in PTSD symptoms but improvement in other areas of their lives, including mood and sleep.” Based on the positive safety and efficacy outcomes from this trial and the other similar Phase 2 studies, FDA granted Breakthrough Therapy Designation for this innovative treatment approach. Breakthrough Therapy is only given for drugs under development that have data indicating that they work better and/or more safe than current medications for a life-threatening illness. This designation is intended to speed up timelines in the path to FDA approval. Though originally planned to start earlier, Phase 3 trials will start in November 2018 due to unforeseen delays with producing and encapsulating Good Manufacturing Practices (GMP) MDMA. If two trials have significant outcomes in 200-300 participants, MDMA-assisted psychotherapy could be an FDA-approved treatment by 2021.
What we see after reprocessing of memories and feelings is not only reduction in PTSD symptoms but improvement in other areas of their lives, including mood and sleep.   Dr. Lisa Jerome MAPS PBC Researcher
In preparation for Phase 3 trials in the USA, Canada, Israel, and Europe, the MAPS Therapy Training Program has expanded to meet the need for well-trained therapists at new study sites. Therapists in this program are trained on the MDMA Treatment Manual, which was first authored by Michael Mithoefer and updated regularly as the therapeutic approach is fine-tuned. Marcela is a lead trainer, along with the Mithoefers, and brings her passion for art to the training program. She teaches trainees about how art can be used as a non-verbal expression of internal processes and offers ways to bring art into therapy sessions during and after altered states of consciousness. The Phase 3 MAPS Therapy Training Program consists of online e-learning modules, reading assignments, a 7-day in-person training to watch and discuss MDMA psychotherapy videos from completed studies, a 5-day in-person meeting for team building and role play, and supervision during an open-label Phase 2 MDMA study. The program will continue to scale and adapt to accommodate more trainees interested in providing MDMA therapy in Expanded Access and post-approval psychedelic clinics. Boulder, CO will be one of approximately 15 study sites in the Phase 3 trials. Enrollment of new participants will start in November 2018. Visit maps.org for more information about study participation, therapist training, and research updates.
  1. Ot’alora, G., Marcela, Jim Grigsby, Bruce Poulter, Joseph William Van Derveer III, Sara Gael Giron, Lisa Jerome, Allison A. Feduccia, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Michael C. Mithoefer, Rick Doblin. “MDMA-assisted psychotherapy for Treatment of Chronic Posttraumatic Stress Disorder: A Randomized Phase 2 Controlled Trial.” Journal of Psychopharmacology. (2018). Full article link. 
  2. Bouso, José Carlos, Rick Doblin, Magí Farré, Miguel Ángel Alcázar, and Gregorio Gómez-Jarabo. “MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder.” Journal of Psychoactive Drugs. 40, no. 3 (2008): 225-236.
  3. Mithoefer, Michael C., Mark T. Wagner, Ann T. Mithoefer, Lisa Jerome, and Rick Doblin. “The safety and efficacy of±3, 4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.” Journal of Psychopharmacology. 25, no. 4 (2011): 439-452.
  4. Mithoefer, Michael C., Ann T. Mithoefer, Allison A. Feduccia, Lisa Jerome, Mark Wagner, Joy Wymer, Julie Holland et al. “3, 4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.” The Lancet Psychiatry. 5, no. 6 (2018): 486-497.
Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.
First Clinical Trial: Social Anxiety in Autistic Adults Successfully Treated with MDMA Therapy

First Clinical Trial: Social Anxiety in Autistic Adults Successfully Treated with MDMA Therapy

The first clinical trial in adults on the autism spectrum investigating MDMA, or any psychedelic substance for that matter, was published in Psychopharmacology this week [1]. This groundbreaking research looked at whether MDMA combined with psychotherapy could help with the severe social anxiety that autistic adults commonly experience.

The drug-therapy combo wasn’t intended to be a treatment for autism itself but was evaluated to see if it could possibly relieve some of the symptoms that limit social adaptability and often affect quality of life.

Twelve study participants were given MDMA or placebo during two all-day therapy sessions with additional non-drug preparatory and integrative therapy sessions. The main findings of this pilot study showed marked improvements in social anxiety and less avoidance of social interactions for the group that received MDMA. Most importantly, limited doses of MDMA in the controlled clinical setting was safe and well tolerated in adults on the autism spectrum.

 91% of participants reported “increased feelings of empathy/connectedness” and 86% experienced “ease of communication” during MDMA/Ecstasy that persisted after use

The rationale for this double-blind study came after a review of accounts in online discussion forums of unsolicited anecdotal reports of MDMA/Ecstasy use in autistic adults in non-medical settings suggested that some had better overall functioning and others had reduced symptoms of anxiety [2].

For her dissertation research, Dr. Alicia Danforth conducted interviews and collected survey data about the MDMA experiences of autistic adults. The survey found that 91% of participants reported “increased feelings of empathy/connectedness” and 86% experienced “ease of communication” during MDMA/Ecstasy that persisted after use.

In 2014, these findings supported the Multidisciplinary Association for Psychedelic Studies (MAPS)’s commitment to sponsor a Phase 2 randomized controlled trial of MDMA-assisted psychotherapy. Dr. Danforth and Dr. Charles Grob, a long-established researcher of psychedelic substances, led the trial at the Los Angeles BioMedical Research Institute at the Harbor-UCLA Medical Center and worked together as a co-therapy team for participants in MDMA-assisted psychotherapy.

The trial design was similar to methods used for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), but included some variations to meet the specific needs of the autistic population. Dr. Danforth said, “This study was the first of its kind, and one of the success factors was working with autistic consultants from protocol development through writing the findings paper. As a result, the investigators had a well-supported rationale for focusing on social anxiety and were able to create a setting that would feel safe and comfortable for a population that often struggles with novel situations and sensory overstimulation.”

For example, to assess whether autistic participants experienced similar subjective effects that would constitute a therapeutic window without becoming overwhelmed, the first four participants received MDMA in the initial session at a dose lower (75 mg) than the typical full dose in PTSD trials (100-125 mg). There were no issues with the 75 mg dose, therefore the dose was escalated to 100-125 mg for the rest of the sessions and participants.

The researchers also wove in mindfulness-based therapy since this approach has previously shown useful for autistic adults and other populations who struggle with emotion regulation, relationships, and tolerance of distress. Unlike the PTSD trials that require the participant to stay overnight in the clinic after MDMA sessions, participants in this study would leave after the session ended with a trusted Study Support Partner who would remain with them at home. This adaptation was made to best accommodate autistic adults who may have elevated anxiety from staying in a clinic setting overnight.

One month after the second experimental session (MDMA or placebo given during 8-hour psychotherapy sessions), the primary measure for gauging social anxiety, the Leibowitz Social Anxiety Scale (LSAS), showed that the group that received MDMA had significantly more improvement in social functioning and less distress in social situations than the placebo group. The large therapeutic effects remained six-months later.

One individual said, “Being a participant in the study affected me in many ways. My self-esteem increased, my social anxiety decreased, love flooded in, my heart healed, and I’m more resilient” [1].

Change in LSAS Total Scores

Baseline to One Month Post Second MDMA/Placebo Session

 

LSAS evaluates impact of social anxiety on areas of a patient’s life.

Beyond just changes in study measure scores, participants and their Study Support Partner reported tangible gains in both family and romantic relationships, with two participants feeling confident enough to start dating for the first time. A participant described this as, “… I have been able to sustain flirtatious conversations for a longer time. In these conversations, I realized communication is not just about talking. Now, I take time to notice my emotions and others’ emotions before talking” [1].

Another two participants felt more at ease talking about and reflecting on gender identity, and overall participants were more adept and comfortable in interactions with friends, family, and the therapy team.

The effects lasted long after MDMA, with remarkable reductions of anxiety in triggering situations, such as entering a new social setting or speaking on the telephone. The investigators noted that they observed, “emergence of apparently intact latent social skills (e.g., ease of initiating and sustaining conversation) that manifested and became apparent to observers during experimental sessions with MDMA when participants relaxed” [1].

Dr. Lisa Jerome, one of the researchers on the team, elaborated on this idea about MDMA by saying, “These findings show that MDMA and psychotherapy can help people, maybe by giving them a whole new set of experiences with social interactions. MDMA isn’t giving people something they didn’t have already, it’s helping them use what they had all along.”

This pilot study was successful in establishing that MDMA-assisted psychotherapy can be used safely in adults on the autism spectrum, and is helpful in relieving severe social anxiety in this population. When asked if new trials would be started soon, Dr. Danforth said, “We hope that the good safety profile and encouraging reduction in social anxiety symptoms will inspire funding for new and larger studies. It remains to be seen how the mainstream autism science community will respond to the new data.”

More clinical trials are needed in a much larger sample of autistic adults before FDA could approve this treatment, but the initial findings are compelling enough to expand research into this novel approach. “We are looking forward to sharing what we learned with other researchers and communities who are committed to improving the quality of care for autistic adults and other populations who struggle with social anxiety,” says Danforth.

Until more data is generated in clinical trials of MDMA in autistic populations, Dr. Danforth strongly encourages autistic individuals to “wait until this type of therapy is more widely available in controlled settings with qualified therapists.” She goes on to say, “In the meantime, we saw an indication that mindfulness-based therapy can also improve social anxiety symptoms. That has certainly been the case in my private practice, where I also have to wait patiently until I can provide MDMA-assisted therapy outside of a clinical trial.”

Read the full text, open-access article here

[1] Danforth, Alicia L., Charles S. Grob Christopher M. Struble, Allison A. Feduccia, Nick Walker, Lisa Jerome, Berra Yazar-Klosinski, and Amy Emerson. “Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: A randomized, double-blind, placebo-controlled pilot study.” Psychopharmacology (2018): 1-12.
[2] Danforth, Alicia L., Christopher M. Struble, Berra Yazar-Klosinski, and Charles S. Grob. “MDMA-assisted therapy: a new treatment model for social anxiety in autistic adults.” Progress in Neuro-Psychopharmacology and Biological Psychiatry 64 (2016): 237-249.

Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.

Do Psychedelics Have the Power to Change Minds?

Do Psychedelics Have the Power to Change Minds?

Originally published on Chacruna.net by Dr. Alli Feduccia
Clinical trials of MDMA, psilocybin, ketamine, and ayahuasca are offering a glimpse that the future may hold psychiatric treatments far different from daily drug prescriptions currently used for anxiety and addictive disorders. Research is only beginning to unravel how these experiences in altered states of consciousness produce large shifts in psychological functioning. Although a purely biochemical model is not inclusive of psycho-spiritual or transpersonal explanations, here I describe what scientific explorations are revealing about how the brain responds when … read full article.
Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.

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