FDA Acceptance and Priority Review: Lykos Therapeutics' MDMA-Assisted Therapy Breakthrough for PTSD

In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has granted priority review to Lykos Therapeutics' (formerly MAPS PBC) MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD). This development not only marks a significant leap in mental health treatment but also holds profound implications for companies like Numinus in the field of psychedelic-assisted therapy. 

Understanding the FDA Priority Review

The FDA's priority review is a special designation reserved for drugs that promise substantial improvements in safety or effectiveness compared to standard treatments. In the case of MDMA-assisted therapy, this acknowledgment underscores the urgent need for innovative approaches to address the complexities of PTSD. MDMA-assisted therapy was only submitted as a new drug application to the FDA by non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) in December 2023.

A Glimpse into MDMA-Assisted Therapy

MDMA-assisted therapy, an important and promising venture in mental health treatment, involves the use of midomafetamine capsules (MDMA) in combination with intentional therapy before, during, and after each medicine session. Based on the data from two published Phase 3 studies completed by MAPS and numerous other trials, MDMA-assisted therapy is a real breakthrough in the treatment of PTSD. 

What This Means for Numinus and the Psychedelic Therapy Landscape

Validation of Psychedelic Therapies

The FDA's early acknowledgment of the potential benefits of MDMA-assisted therapy provides a significant boost to the legitimacy of psychedelic therapies. This is good news that we anticipate will pave the way for broader acceptance and integration of these treatments into mainstream mental healthcare.

Expanding Treatment Options

If (and when) approved, this therapy would represent a monumental shift in the available treatment options for PTSD. Companies like Numinus, already at the forefront of psychedelic therapy, may see expanded opportunities to offer innovative solutions for people suffering from post traumatic stress disorder. 

PTSD, a grave mental health condition stemming from traumatic events, grips approximately 13 million Americans each year. Military personnel have a greater prevalence of PTSD than the general population, however, it may not be as widely known that that the largest cause of PTSD is non-combat-related trauma (e.g., sexual violence, unexpected death of a loved one, life-threatening traumatic event or interpersonal violence). Women and marginalized groups bear a disproportionate burden, underscoring the urgency for inclusive and targeted treatment. With this treatment available, Numinus will be able to provide this option for relief that these people need and deserve across our network of clinics.

Heightened Focus on Safety and Efficacy

The FDA's priority review signals a keen focus on ensuring the safety and efficacy of psychedelic treatments. This emphasis aligns with Numinus's commitment to providing evidence-based and responsible psychedelic-assisted therapy.

Psychedelic-Assisted Therapy Training 

With increasing public awareness and acceptance of psychedelic medicine, our training program is pivotal in preparing professionals to meet the demand for responsible and safe MDMA-assisted therapy. As the therapeutic landscape expands, Numinus-trained and certified practitioners will be ready to integrate psychedelic assisted protocols into their practice. This transformative period presents opportunities for collaboration and cements the role of our training programs in moving this type of treatment forward. Learn more about our certification pathway here.

Looking Ahead

We are deeply invested in the transformative power of psychedelics and are thrilled to learn about the FDAs priority review of MDMA-assisted therapy. Our team wholeheartedly believes this development can and will change lives.

Group Ketamine-Assisted Therapy: A Therapist's Musings

Group Ketamine-Assisted Therapy From The Perspective Of A Therapist

 

When I first started bringing up the idea of group ketamine therapy to my patients as a potential option, I did so somewhat timidly, often prefacing the conversation with “ok, now hear me out” or “I know it sounds strange…group therapy but with ketamine”. This was in part because the idea and execution of it was new to me, my hopes for positive outcomes were still a hypothesis and in part, because the patients I spoke with about it were immediately incredulous and skeptical, not only of group therapy work, but also of throwing a consciousness-altering medicine into the mix. After seeing firsthand the positive outcomes of group sessions that my co-facilitator and I have led, and working closely with facilitators of other groups with similarly outstanding results, I approach the group ketamine conversation differently: with confidence and earnest convictions of the benefits for those who bravely enter this space.

I will say here what I say to my patients who I think are a good fit but who are skeptical of this model: healing happens in groups. Yes, individual work is important, and for some people that individual work needs to happen first before entering a group space, but for generations across time, across cultures, and across the world, healing has happened in communities, when we witness and are witnessed in this process and we begin to embody the sense that we are all connected in more ways than we ever dreamed.  

During the medicine sessions, this is not group talk therapy, although we are together in the same room each person is having their own experience with the medicine. Typically, everyone is wearing eyeshades and music is playing while at least two facilitators carefully watch over the group, providing support when needed, but mostly leaving participants to explore their own innate ability to heal themselves, with support from others. All are welcome in this room, laughing, crying, and complete silence, it is all ok and requires no explanation.  

When we have shared experiences of transcendence, of entering the depths of sorrow, of embodying joy and playfulness, of connecting deeply with those around us, we find that we are better able to do those things in our everyday lives: with our families, our friends, and our community. We are able to bring these learnings back to those we love, facilitating a deeper connection with others, and ourselves.  And for those who feel they lack those relationships in their lives currently, practicing this kind of vulnerability opens the door of possibility that community is not only possible but accessible. Connection often doesn’t just happen in the culture we currently live in, it's not a given - it must be sought out and practiced. Coming together in a group with a shared purpose gives each of us the opportunity to practice vulnerability and connection with others in ways we are not often afforded in our everyday lives.  

I know I keep referring to “we” and “us”.  I have done this because we come into this group together. The group is not a service we as therapists and medical providers are giving to you. We are in this place together, learning and growing along with you, and for that we thank you for taking this leap.  

 

--

 

If you're interested in learning more about our Group Ketamine-Assisted Therapy sessions, visit our webpage. 

If you're in the Utah area, we are leading Group Ketamine-Assisted Therapy sessions focused on chronic and serious illness at our Murray Clinic starting October 9th. One-on-one intake visits are currently open until October 4th. To learn more or to book your spot email INFO-UTAH@NUMINUS.COM or call 1 (801) 369-8989.

 

 

The Impact of Psychedelic Harm Reduction In Therapy

3 Benefits of Using a Harm Reduction Framework in Your Therapy Practice

According to a recent study by the National Institute of Health, psychedelic use is on the rise. The percentages of young people who said they used hallucinogens in the past year had been fairly consistent for the past few decades, until 2020 when rates of use began spiking. In 2021, 8% of young adults said they have used a psychedelic drug in the past year, the highest proportion since the survey began in 1988. Reported hallucinogens included LSD, mescaline, peyote, shrooms, PCP and MDMA (aka molly or ecstasy).

With this increase in recreational psychedelic use, there is a growing need for mental health professionals to expand their practices to support harm reduction and psychedelic integration needs. Here are the top 3 reasons practitioners should adopt a harm reduction framework in their therapy practice.

 

1. Builds Trust & Rapport With Clients

By maintaining a non-judgemental, accepting, compassionate, curious, and positive stance when exploring a client’s substance use, as well as other risky or harmful behaviours, you are directly contributing to the trust that client has with you. Being open and curious signals to the client that they are safe to walk through their thought process and current decision-making around psychedelic use, where you can gently advise on any dangers and practices they should take into consideration. When supported in this way, these clients are more likely to stay with you long-term and if you decide to provide psychedelic-assisted therapy in the future, they may feel comfortable turning towards psychedelic care provided by you. 

 

2. Helps Clients To Make Informed Decisions

When psychedelic medicines are used outside of clinical settings, proper education, preparation, and support can mitigate potential harms and increase the likelihood of clients having productive experiences (Gorman et al., 2021).  

Particularly with the medicines used in psychedelic-assisted therapy, clients may start treatment with some inaccurate information about the psychedelic medicine being used. The internet (particularly social media platforms) is full of misinformation about psychedelic medicines, their effects, adverse effects, and anticipated experiences. 

When a client has a more fulsome understanding of experiences and the decisions associated, potential benefits and harms are affected in ways that can enhance and protect their experiences, further contributing to trust this client has with you. 

 

3. Presents A Unique Opportunity To Work With Your Clients

When discussing psychedelic use, an important role you can play with your clients is to help with the integration work. Working on integration is your opportunity to keep the positive changes engendered by psychedelic experiences alive. In this regard, good integration work with your clients will help facilitate lasting changes and could reduce the need for ingesting medicines recreationally outside of a clinical setting. Not only is this an opportunity to work more with your client, but it’s a unique opportunity to really dive into positive and meaningful changes that are important to your client, which can facilitate deeper connection and meaning making as part of your regular appointments. 

 

In Conclusion: 

“Using a harm reduction framework in your clinical practice allows you to support your clients with non-judgmental, compassionate, and acceptance-oriented care. We should expect that clients may choose to use substances outside of the clinical setting, and that providers can play an important role in mitigating any harms associated with that, through building trust and rapport. We teach a harm reduction framework in our Psychedelic-Harm Reduction and Integration course at Numinus, which includes transparent discussions around the legal and ethical responsibilities in doing this work. Psychedelic use is going to continue to rise as more folks seek the healing potential of these medicines, so education in this area is going to become increasingly important.” 

- Amanda Giesler, Director of Training

 

Learn More: 

Join us for a 2-day introductory workshop on the practice of Psychedelic Harm Reduction and Integration (PHRI) and learn the tools needed for educating clients about altered states of consciousness and how to integrate these experiences. Click here to learn more.

 

*The continuing professional development program in no way promotes, condones, or facilitates illegal activity, and is strictly for educational and harm reduction purposes only. Please be aware that certain psychedelic substances still remain illegal in many jurisdictions, including Canada. This program and the contents of this website do not constitute medical advice, and are not a substitute for professional medical advice and treatment.

A New Chapter Begins: MDMA-Assisted Therapy

Introduction

In recent years, there has been a surge of an increased interest in psychedelic-assisted therapy as a new and potentially more effective way to treat a variety of mental health conditions. One such approach that has gained significant attention is MDMA-assisted therapy. MDMA, commonly known as Molly or ecstasy, is considered an “empathogen'' – a class of psychoactive substances known to produce including increased feelings of emotional connection, openness, and empathy towards self and others. When used in safe, therapeutic settings, MDMA has shown promising results in helping individuals overcome trauma, anxiety, and other psychological disorders.

The effects of MDMA on the brain

MDMA, which stands for 3,4-methylenedioxymethamphetamine, works on the brain by acting on various neurotransmitters and regions of the brain.

Brain imaging after administration of MDMA shows there is decreased amygdala activation and reduced fear response. [1][2] For an individual with PTSD, a part of the brain called the amygdala is overactive. The amygdala is highly involved in fear and threat detection, and with trauma the amygdala is highly overactive. It is constantly firing alarm bells, signaling a lack of safety and the need to be in high-alert, protective mode. [8][11] This kind of brain state makes therapy extremely difficult. However, under the influence of MDMA, individuals become less fearful as the amygdala relaxes.

In addition to its effects on the amygdala, MDMA also increases the release of several important neurotransmitters, serotonin, norepinephrine, and dopamine, creating a surge of positive emotions and bringing a sense of calmness, openness, and emotional engagement. While classic psychedelics such as LSD and psilocybin activate serotonin 5-HT2A receptors, MDMA primarily impacts serotonin 5-HT1B receptors, and this seems to be a key component in MDMA’s pro-social, empathogenic effects. [3][4] MDMA also releases a hormone called oxytocin, which may also contribute to MDMA’s emotional effects, however research remains unclear whether there is a causal effect. [5]

So when you give MDMA to a person with PTSD, the fear response is reduced, their fight or flight system relaxes, and they can finally move toward the source of their suffering and emotionally engage in therapy without becoming overwhelmed. MDMA alone is not a cure for PTSD. But because of MDMA’s profound effects on the brain, it makes therapy much more effective and allows patients to address the root cause of the problem—and this is what sets MDMA-assisted therapy apart from other traditional treatments for trauma.

Understanding MDMA-Assisted Therapy

MDMA-assisted therapy involves the administration of a carefully controlled dose of MDMA in conjunction with psychotherapy sessions. Unlike recreational use, which often takes place in a social setting, MDMA-assisted therapy is conducted in a clinical environment, supervised by trained professionals. The therapy typically consists of a few preparatory sessions, the MDMA session itself, and follow-up integration sessions.

During an MDMA-assisted therapy session, the patient ingests a prescribed dose of MDMA, usually in the form of a capsule. As the medicine begins to take effect, a unique therapeutic environment becomes available, allowing individuals to explore traumatic experiences and deeply rooted emotional issues with heightened introspection, self-compassion, and openness.

 

The Potential Benefits of MDMA-Assisted Therapy

 

MDMA Research

Clinical research on MDMA-assisted therapy has gained significant momentum in recent years, with several studies demonstrating promising results. Here are a few examples of notable research and studies conducted in this field:
Phase 3 Trials for PTSD Treatment: The Multidisciplinary Association for Psychedelic Studies (MAPS) has conducted Phase 3 clinical trials investigating the efficacy of MDMA-assisted therapy for treating PTSD. One study published in Nature Medicine in 2021, looked at 90 participants who were dealing with chronic PTSD from a variety of different causes (e.g., abuse, combat, sexual trauma). It’s also important to note that these patients were treatment-resistant, meaning they had suffered from PTSD without relief for an average of 14 years. All participants completed a 12-week treatment program consisting of 3 full-day dosing sessions, during which they received either MDMA or a placebo, plus weekly nondrug psychotherapy sessions. [9]
No serious adverse effects were detected beyond transient, mild symptoms (such as nausea or sweating) during dosing sessions. No increases in suicide risk or potential for abuse were noted in the MDMA group relative to placebo. Most notably, two months after treatment, 67% of the MDMA cohort no longer qualified for PTSD diagnosis, compared with 32% of the placebo group. In addition, 88% of those in the MDMA group experienced a clinically significant reduction in symptoms, and even one year after completing the study, the therapeutic effects continued. These kinds of results are typically unheard of in the world of psychiatry. It means that the majority of these individuals—who had suffered from chronic, severe PTSD for an average of 14 years—can now live a normal life—free from triggers, flashbacks, nightmares, hopelessness or suicidality.

Study on Social Anxiety in Autistic Adults: Another study examined the effects of MDMA-assisted therapy on social anxiety in autistic adults. Currently, there are no FDA-approved drug treatments for autistic adults with social anxiety, and conventional anti-anxiety medications lack clinical effectiveness in this population. [6]
MAPS sponsored a randomized, double-blind, placebo-controlled exploratory pilot study that aimed to assess MDMA-assisted therapy for treating social anxiety in 12 adults on the autism spectrum. Participants were randomized to receive either MDMA (75, 100, and 125 mg) or inactive placebo during two 8-hour dosing sessions. The primary outcome was change in Leibowitz Social Anxiety Scale (LSAS) scores from baseline to one month after the second experimental session. Outcomes were measured again five months later. [6]

Results showed an improvement in LSAS scores, meaning reduced symptoms of social anxiety, that was significantly greater for the MDMA group than the placebo group. Six month follow-up scores continued to show similar results, with a reduction in LSAS scores that remained statistically significant. The findings suggest that MDMA-assisted therapy may be a promising approach for addressing social anxiety and improving social functioning in this unique patient population.
Pilot Study for Anxiety Associated with Life-Threatening Illness: A pilot study published in 2019 explored the use of MDMA-assisted therapy in alleviating anxiety and existential distress in individuals with life-threatening illnesses. The 18 participants received either a 125 mg dose of MDMA or placebo during two day-long experimental sessions. These were also paired with two 8-hour psychotherapy sessions. [10]
The study found that those in the MDMA group had greater improvements in anxiety, depression, and quality of life measures compared to those who received placebo. suggesting that MDMA-assisted therapy may be a valuable adjunctive treatment for addressing psychological distress in this specific population. [10] Participants’ attitudes towards death shifted after MDMA, as well as their daily coping mechanisms, as demonstrated by greater emotional and functional quality of life at the study endpoint. These preliminary findings suggest that MDMA-assisted psychotherapy might have the potential to provide long-term benefits for people who have or are overcoming a serious illness.
These studies, among others, demonstrate the growing body of evidence supporting the potential efficacy of MDMA-assisted therapy in various mental health conditions. Continued research and clinical trials are underway to further elucidate the therapeutic benefits, optimize treatment protocols, and ensure the safety and efficacy of this innovative approach to psychotherapy.

Challenges and Considerations

While the results of MDMA-assisted therapy are promising, it is essential to acknowledge the challenges and considerations associated with its use. These include:

Conclusion

MDMA is now on track to be the first psychedelic medicine likely to win FDA approval, perhaps as early as next year. It's an exciting milestone in psychiatry. Assuming this gets approved, it will be the first medicine approved that's a curative approach to trauma, instead of just treating the symptoms. It would also be the first FDA-approved medicine requiring concurring therapy. Meaning, you cannot get a prescription for this medicine if you’re not committed to the therapy.

MDMA-assisted therapy represents a promising approach to mental health treatment, offering a unique and transformative experience for individuals struggling with trauma, anxiety, and other psychological disorders. While it is not a standalone

References:

1. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27(6):1025-1033.
2. Bedi G, Phan KL, Angstadt M, de Wit H. Effects of MDMA on sociability and neural response to social threat and social reward. Psychopharmacology (Berl). 2009;207(1):73-83.
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7123941/
4. https://www.sciencedirect.com/science/article/abs/pii/S0149763411002168
5. https://www.sciencedirect.com/science/article/abs/pii/S0306453014001255?via%3Dihub
6. Wolfson PE, Andries J, Feduccia AA, et al. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020;10(1):20442. Published 2020 Nov 24. doi:10.1038/s41598-020-75706-1
7. https://link.springer.com/article/10.1007/s00213-018-5010-9
8. Morey RA, Gold AL, LaBar KS, et al. Amygdala volume changes in posttraumatic stress disorder in a large case-controlled veterans group. Arch Gen Psychiatry. 2012;69(11):1169–1178. doi:10.1001/archgenpsychiatry.2012.50
9. Hysek CM, Schmid Y, Simmler LD, et al. MDMA enhances emotional empathy and prosocial behavior. Soc Cogn Affect Neurosci. 2014;9(11):1645-1652.
10. https://www.nature.com/articles/s41598-020-75706-1
11. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27(6):1025-1033.

The Healing Potential of Psychedelic-Assisted Therapy for Eating Disorders

Eating disorders affect millions of people worldwide, presenting complex challenges that often require comprehensive and innovative approaches to treatment. In recent years, there has been growing interest in the potential of psychedelic-assisted therapy as a transformative tool in the realm of mental health. This blog post explores the emerging field of psychedelic-assisted therapy for eating disorders, shedding light on its promising benefits and the implications it may have for the future of treatment.

Introduction

Eating disorders affect at least 9% of the population, or 70 million people, worldwide[8], and this number is increasing. A review of worldwide data found that eating disorder diagnoses more than doubled from 2000-2018, with the trend was consistent across regions, age groups, and genders.[10]

These conditions are also serious, falling among the deadliest mental illnesses, second only to opioid overdose.[8] Every year, 10,200 deaths occur as the direct result of an eating disorder—that’s one death every 52 minutes.[9]

 

Understanding Eating Disorders

“Eating disorders are a window into the struggle of the soul.”

People don’t choose eating disorders. Nobody wakes up one day and says “I’d like to have anorexia”—If they do, they’re seriously misinformed. Eating disorders aren’t choices, but rather serious multi-faceted and biologically influenced illnesses. An individual may consciously decide to purge or over-exercise at first, but before long, this disordered relationship with food and one’s body can become a deeply-ingrained subconscious pattern that takes on a life of its own. When left untreated, eating disorders can lead to serious, and sometimes life-threatening, physical and psychological consequences, underscoring the urgent need for effective therapeutic interventions.

Thankfully, eating disorder behaviors are learned behaviors and can be unlearned—but it takes time. Everyone has the capacity for full recovery. Part of the work in recovery is to uncover the meaning or purpose behind the symptoms.

 

The Limitations of Traditional Treatments

Conventional treatment approaches, including cognitive-behavioral therapy and medication, have demonstrated some effectiveness in managing eating disorders. However, there are currently no FDA-approved treatment options for anorexia nervosa and only one for bulimia nervosa and binge-eating disorder respectively. While depression commonly occurs with most eating disorders, traditional antidepressants (i.e. SSRIs) often lack efficacy in patients with anorexia. Even when patients are able to take advantage of available treatments, many continue to struggle with symptoms, and relapse rates remain high.

Studies have found that over a third of all patients treated for anorexia or bulimia end up relapsing within the first few years of completing treatment. The highest risk for relapse from anorexia occurs in the first 18 months (about 1 and a half years) after treatment, with 35% falling back into eating disordered behaviors.[1]

While the onset of bulimia usually occurs during adolescence or early adulthood, it tends to persist for several years, either chronically or intermittently. Treatment does help most people with bulimia achieve long-lasting recovery, but relapse still is a significant concern, with rates of up to 41% of former patients resuming bulimic behaviors within 2 years.[2]

Recognizing these challenges, researchers and clinicians have continued to search for new and improved ways to help individuals with eating disorders find more long-lasting and complete healing, including the use of psychedelic-assisted therapy as a potential alternative or complementary treatment modality.

 

The Role of Psychedelics in Healing

Psychedelic substances like psilocybin, MDMA, and LSD have shown promise in facilitating profound psychological healing in individuals dealing with depression, PTSD, substance abuse, eating disorders, and other mental health conditions. Though theoretical mechanisms of action of psychedelic medicines are still being investigated, a growing body of research points suggest that psychedelics create desirable brain states that can accelerate therapeutic processes and make eating disorder interventions easier to receive. The desirable brain states in

 

Research Studies

Group Ketamine-Assisted Therapy for Eating Disorders [3]

This pilot study, led by Dr. Reid Robison, Chief Clinical Officer of Numinus, explored the use of group ketamine-assisted psychotherapy (KAP) in a residential eating disorder treatment facility. 5 individuals with eating disorder diagnoses and comorbid mood and anxiety disorders received weekly intramuscular ketamine injections in a group setting followed by non-drug psychotherapy over 4 weeks.

Regarding the outcomes, the study found promising results. Group KAP was feasible and well-tolerated, with high patient satisfaction and treatment adherence rates. Participants experienced reduced symptoms of depression, anxiety and showed significant improvements in eating eating symptoms and quality of life, with effects persisting at a 6-month follow-up.

Participant quote:

“Trying ketamine allowed me to see the possibility of a life I could have. While the effects did not last, my very first experience snapped me out of a state of life-long, deep disconnection that I didn't even know I had been experiencing. Suddenly, I was able to live in the world in the way people had always described it. Though I am still trying to figure out how to attain that level of connection after catching a glimpse, that one experience was so essential. I could finally feel hunger and fullness cues. I felt what it's like to live in a body, instead of living a short distance from it. I felt connected to others and genuinely cared about their well-being. I felt human for the first time in a long time.”

 

Psilocybin-Assisted Therapy for Anorexia [4]

This study being conducted by Compass Pathways in collaboration with University of California San Diego,  is exploring the safety, tolerability, and efficacy of psilocybin-assisted therapy for patients with anorexia. Preliminary results from 10 participants who received a single 25 mg dose of synthetic psilocybin (~3.5 grams of dried psilocybin) shows:

 

Psilocybin-Assisted Therapy for Binge-Eating Disorder [5]

This Phase II study is currently underway at the University of Florida in collaboration with Tryp Therapeutics and happens to be the first ever psilocybin-assisted therapy study addressing binge-eating disorder. Interim analysis of five early participants has found:

MDMA-Assisted Therapy for Eating Disorder Symptoms [6]

This study investigated the effects of MDMA-assisted therapy on adults with severe PTSD, specifically exploring its impact on eating disorder symptoms. A total of 90 participants with severe PTSD received treatment in a double-blind, placebo-controlled trial. At baseline, 13 participants had EAT-26 scores in the clinical range, and 28 had scores in the high-risk range, despite the absence of active purging or low weight. After finishing the study, there was a significant reduction in total EAT-26 scores in the entire PTSD group following MDMA-assisted therapy compared to placebo. Moreover, significant reductions in total EAT-26 scores were observed in women with high EAT-26 scores (≥11 and ≥20) following the study protocol.

 

Other studies:

 

GROUP PHASE INDICATION STATUS
MAPS Phase II MDMA for anorexia and BED Anticipated start date in 2023
Johns Hopkins Phase I Psilocybin for anorexia Enrollment complete
Imperial College Phase I/II Psilocybin for anorexia Enrollment complete
TRYP Phase II Psilocybin for BED Enrolling
XPIRA Phase II Psilocybin for Anorexia Anticipated start date in 2023
COMPASS Phase II Psilocybin for Anorexia Enrolling

 

 

Integrating Psychedelics with Conventional Models

Integration of psychedelic-assisted therapy with conventional eating disorder treatment requires careful consideration of medical and safety factors, as well as the crucial involvement of specialized eating disorder clinicians. These clinicians have the expertise to navigate the unique challenges and triggers associated with eating disorders, helping patients access and integrate psychedelics in a safe and therapeutic manner. Their involvement ensures a comprehensive treatment approach that combines the benefits of psychedelic therapy with the tailored support required for individuals with eating disorders, leading to more effective and sustainable outcomes. We view the role of psychedelics as an adjunctive to traditional treatments, not a “replacement.”

 

Conclusion

Psychedelic-assisted therapy represents a promising frontier in the treatment of eating disorders, offering new possibilities for deep healing and transformation. While further research is needed to fully understand its effectiveness and establish appropriate guidelines, preliminary studies and anecdotal evidence suggest that this approach holds tremendous potential. As the field progresses, it is essential to strike a balance between innovation and responsible practice, ultimately providing individuals with hope and a path toward recovery from their eating disorders.

 

References

  1. Arcelus, Jon et al. “Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies.” Archives of general psychiatry 68,7 (2011): 724-31. https://doi.org/10.1001/archgenpsychiatry.2011.74
  2. BMC Psychiatry. 2019; 19: 134. Published online 2019 May 6. doi: 10.1186/s12888-019-2112-9
  3. https://jeatdisord.biomedcentral.com/articles/10.1186/s40337-022-00588-9
  4. https://compasspathways.com/comp360-psilocybin-therapy-shows-potential-in-exploratory-open-label-studies-for-anorexia-nervosa-and-severe-treatment-resistant-depression/
  5. https://tryptherapeutics.com/updates/tryp-therapeutics-announces-interim-results-for-its-phase-ii-clinical-trial-for-the-treatment-of-binge-eating-disorder-with-psilocybin-assisted-psychotherapy
  6. https://www.sciencedirect.com/science/article/pii/S0022395622001303
  7. https://pubmed.ncbi.nlm.nih.gov/9797933/
  8. (Ghaderi et al., 2018, Ward et al., 2019)
  9. Deloitte Access Economics. The Social and Economic Cost of Eating Disorders in the United States of America: A Report for the Strategic Training Initiative for the Prevention of Eating Disorders and the Academy for Eating Disorders. June 2020. Available at: https://www.hsph.harvard.edu/striped/report-economic-costs-of-eating-disorders/.
  10. Galmiche M, Déchelotte P, Lambert G, Tavolacci MP. Prevalence of eating disorders over the 2000-2018 period: a systematic literature review. Am J Clin Nutr. 2019;109(5):1402-1413. doi:10.1093/ajcn/nqy342

Bicycle Trip: Commemorating Albert Hofmann’s Ride

Artwork by Haruka Sato. Instagram: @here_is_haruka

BY REID ROBISON, MD, MBA, CHIEF MEDICAL OFFICER, NOVAMIND & KIRSTEN HIRST, NOVAMIND

On April 19th, 1943, the chemist Albert Hofmann first experienced the full effects of LSD during a psychedelic bicycle ride home from work. For those working to harness psychedelics for the betterment of humankind, Bicycle Day marks an important moment in medical and spiritual history.

Basel, Switzerland 1943

It was a wet Monday in mid-April when Albert Hofmann hopped on his bicycle and began his daily ride to work at Sandoz laboratories.

The streets were quieter in those days. Wartime restrictions on automobiles had made sure of that. Cycling through the picturesque city speckled with medieval artifacts and colorful baroque homes, Hofmann was preparing himself for an interesting experiment.

Three days previously, the 37-year-old chemist had stopped in the middle of his work, feeling a bit funny. Resigning early, Hofmann had stumbled home. For two hours, his curious condition intensified until he entered a strange dream-like state. The daylight outside Hofmann’s window had become almost unbearably bright as prisms of colors bounced through his visual field.

Emerging from the experience, Hofmann was perplexed.

Because of the sudden severity of the event, Hofmann guessed that the peculiar episode might have resulted from his chemical work that day. Hofmann had been working with lysergic acid diethylamide tartrate, aka LSD-25. In 1938, the chemist had first synthesized the substance for potential medical use, but it hadn’t raised any particular interest. Five years later, Hofmann had decided to produce LSD-25 again, following a gut instinct that there was some greater potential latent in the substance’s properties.

Still, the LSD answer was not an entirely satisfactory one to explain Hofmann’s experience that Friday. A consummate chemist, and knowing full well the toxic nature of the compounds he worked with, Hofmann was always cautious.

He reasoned that if it was the LSD solution that had caused such strange effects, then the exposure must have been minuscule—perhaps only a trace amount had been picked up by his fingertip and absorbed through his skin. Still more baffling to Hofmann was the strength of the effect on him. Friday’s two-hour long episode seemed too fantastic to have arisen from such a small quantity of any known substance.

That day, April 19th, 1943—Hofmann intended to test his hypothesis. He walked into the lab, resolved to take a small quantity of the LSD-25 solution, and determine if the bizarre phenomenon could be replicated.  The mystical nature of the previous Friday’s experience was, after all, just the sort of thing that had persuaded Hoffman to study chemistry. Insight to explain magic—that’s what he would be gaining by his experiment.

Drawing reference from his study of similar compounds, Hofmann decided on 0.25 milligrams (or 250 micrograms) of the liquid LSD-25. It was a miniscule quantity—just .00005 teaspoons. After making a quick note in his lab book, Hofmann drank.

4/19/43 16:20: 0.5 cc of 1/2 promil aqueous solution of diethylamide tartrate orally = 0.25 mg tartrate. Taken diluted with about 10 cc water. Tasteless.  

Forty minutes later, the unusual sensations of the previous Friday returned. Mystery solved. 

Feeling the distortions began to cloud his vision, Hofmann quickly began to jot down the initial effects in his journal: Visual distortions. Symptoms of paralysisDesire to laugh.

Hofmann hardly managed to scribble the last word before the kaleidoscopic perceptions of a few days previous flooded in. Hofmann grabbed his assistant and asked him to escort him home. Off on their bicycles they went.

Ottawa, Ontario 1953

A decade after Hofmann’s self-experiment, two psychiatrists spent a sleepless night conversing in an Ottawa, Ontario hotel.

Humphry Osmond and Abram Hoffer were set to speak at a conference the next day, but instead of resting, they were up late discussing the difficulties of their profession. Their common problem was the challenge of treating patients with alcoholism.

At around four in the morning Osmond and Hoffer had an idea: what if LSD could be used to treat alcoholism?

At first, the two friends laughed at themselves. That’s absurd. LSD makes you delirious, and so does severe alcohol withdrawal. Why would we do that? But when the pair of psychiatrists stopped laughing the idea was still there, and there was something to it.

From their previous work, Osmond and Hoffer noticed that when alcoholism patients hit rock bottom, they would go through ‘delirium tremens’—a catalyzing experience that, while physically painful, often brought them to a place of being willing to to give up their drinking habits. Could LSD replicate the experience of delirium tremens? Osmond and Hoffer wondered.

As they continued to converse, the psychiatrists’ idea seemed less and less absurd. What if they purposely occasioned a difficult but transformative experience in their clients simply by giving them a medicine like LSD? Thus, a hypothesis began to emerge.

Basel, Switzerland 1943

Forms of gingerbread houses and vibrant landscape teetered in and out of Albert Hofmann’s vision. The world around had become a perilous enclosure of distorted mirrors. He was racing through Basel. Or was he? He felt stuck, pedaling slowly through the thick spring air.

When he was finally home and laying on his sofa, Hofmann felt the intensity of his bicycle ride escalate. The room spung around him with alien malformity. The pleasant colors of Friday were now saturated with a new level of strange intensity. Occasionally, Hofmann was visited by the frightful form of his neighbor, slithering in and out of the room as a terrifying witch, face veiled in a colorful mask.

Unsure of how to respond to the delusions, Hofmann lay there—nearly overcome by the sensory experience that entangled him. As is common in many initial encounters with psychedelics, Hofmann concluded that he was either losing his sanity or approaching his death.

Or maybe I’ve already passed beyond the end, Hoffman thought. After all, at times he almost seemed to hover outside of himself. Perhaps his spirit was pulling away from his body. No. It is too soon, Hofmann thought trembling. It is far too soon to leave my family, and it would be so unfortunate to leave my work unfinished.

But then gradually, the monstrous turned magical. Gratitude for the retreating unknown warmed Hofmann’s mind and rationalized his thoughts. Whimsical synesthesia overtook the alarming sensations of a few moments previous. His thoughts emerged into the air, each dancing playfully as its own image—beautiful shapes circling in and out of his vision. A doctor, arriving for a house call shortly after the peak of the delirium, confirmed that Hofmann’s health appeared to be in no real danger.

Hollywood, California 1953

On a clear Sunday morning, Humphry Osmond nervously made his way to Aldous Huxley’s home in West Hollywood. Per Huxley’s request, Osmond had brought with him 400mg of mescaline.

It was 1953, and the 58-year-old writer was living in Los Angeles with his wife Maria. Over two decades earlier, the publication of Huxley’s Brave New World had skyrocketed the author into a highly prolific and successful writing career. Now settled in Hollywood, Huxley had added screenplays and editorials to his growing library of work.

Huxley’s latest fascination with eastern mysticism coupled with his long-time interest in the hallucinogenic properties of certain plants had eventually led the writer to Osmond’s work with mescaline. In 1953, Huxley began writing to the psychiatrist about his interest in mind-expanding substances.

When Osmond arrived at the Huxleys’s home, he was greeted by the gangly writer dressed in a modest pair of blue jeans. Huxley led Osmond back to his study, a library of books complete with a small table and a wicker chair for writing.

Osmond prepared the mescaline on the table, stirring the shining white crystals into the glass until they dissolved. Suppose he pours half of the full glass into an adjacent flower vase? Osmond thought to himself. As the psychiatrist would recall years later, “I did not relish the possibility, however remote, of finding a small, but discreditable niche in literary history as the man who drove Aldous Huxley mad.”

Huxley did not go mad. Much to Osmond’s relief, the writer considered the experiment “an experience of inestimable value.”

While under the effects of the mescaline, Huxley had lived a day visiting a drug store and enjoying a casual evening with friends as one of the most transformative of his life.

 In his book The Doors of Perception, Huxley wrote what would become the most famous trip report of the modern day. For Huxley, the journey had reaffirmed his personal philosophy that hidden inside each of us is a special kind of awareness, one that does not require patience for the arrival of a divine gift—but can instead be accessed on demand through tools like mescaline and LSD.

“The man who comes back through the door will never be quite the same as the man who went out,” Huxley would later write.

New York, New York 1957

Humphry Osmond had just flown in from Saskatchewan to present at a conference for the New York Academy of Sciences. It was a cool day in mid-November and the sun was setting over the Rockefeller Institute in Manhattan. Just to the north, the summer perennials of the New York Botanical Garden had given way to a blanket of autumn-dusted leaves.

Four years had passed since Osmond and Hoffer’s late-night laugh over their strange LSD hypothesis. In the interim, and surprising both friends, the theory had yielded remarkable results. Over the past few years, the two psychiatrists had successfully given their experimental LSD therapy to over 700 patients. Of those treated, nearly 45 percent had not returned to drinking after a year. According to Hoffer, “Many of them didn’t have a terrible experience. In fact, they had a rather interesting experience.”

At the New York conference, Osmond stood in front of his colleagues and spoke about his work thus far with LSD and mescaline: “For myself, my experiences with these substances have been most strange, most awesome, and among the most beautiful things in a varied and fortunate life,” Osmond continued, “These are not escapes from but enlargements, burgeoning of reality.”

During the conference, Osmond suggested that the so-called “psychotomimetic agents” be given a more inclusive name that spoke to the complete capacity of these drugs.

He chose the term “Psychedelic”, meaning “mind-manifesting.” For the psychiatrist, the word was “clear, euphonious and uncontaminated by other associations.”

Later, Aldous Huxley wrote to the psychiatrist with an alternative name to consider (true to his literary niche, Huxley wrote it as a rhyme): ”To make this trivial world sublime, take half a gram of phanerothyme.” (“Phaneros” means “visible” and “Thymos” means “soul” in Greek.)

In a quippy rejection to Huxley’s suggestion, Osmond replied, ”To fathom Hell or soar angelic, just take a pinch of psychedelic.”

Basel, Switzerland 1943

Basel, Switzerland has long been regarded as one of the world’s best cycling cities. In 1943, an encroaching war and the monotony of required daily use had likely watered-down any novelty gained from pedaling through the city’s aged cobblestone roads or past the shining Rhine river. But on that rainy afternoon in mid-April, Albert Hoffman experienced a bicycle trip like no other.

The next morning, Hofmann woke up to a warm spring sun shining like drops of glitter in the wet garden.  For the whole day, Hofmann could feel the rich depth of the world around him. Food tasted better. The earth looked better.

Hofmann’s LSD trip had been difficult, if not frightening, at times. But emerging into a reality with each of his senses refreshed, the chemist recognized that it was the frightening aspects of his trip that were, in fact, key to the entire experience. Hofmann’s ride had left him with the self-tested conviction that difficult does not equal bad.

Years later, in a speech delivered to the 1996 Worlds of Consciousness Conference in Germany, Hofmann reflected on his experiences with LSD: “Only when we are conversant with both, heaven and hell, is our life full and rich; and it is fuller and richer the more deeply we experience both. The psychedelic experience can lead us to the deepest depths and the highest heights, to the boundaries of that which humankind is capable of experiencing.”

Originally Published on truffle report

We’re Heading Into Pivotal Years for Psychedelics – Here’s Why

By Dr. Reid Robison, Chief Medical Officer

I had the good fortune of attending the Horizons Conference in NYC in December, one of the more scientifically rigorous (and longest running) psychedelic medicine conferences. With both MDMA and psilocybin moving through the drug development process and a steady stream of new and exciting developments from stakeholders in space, I’m convinced that the next couple of years will be pivotal for psychedelics. It’s inspiring to see the progress being made in this field.

Progress in MDMA research

I really appreciated the openness, transparency and thoughtfulness of MAPS and their update on the path toward MDMA approval for PTSD. After nearly two decades of tireless work led by Rick Doblin, including clinical trials, therapy training programs, and several high impact publications, the phase III MDMA study is well underway. After incredibly promising results from the first part of the phase III study (announced last year), MDMA-assisted psychotherapy is poised for approval by the FDA as a potential treatment for PTSD by the end of 2023. Equally exciting were the goals that MAPS shared of training 30,000 therapists by 2031 and treating 1 million people with PTSD by 2031.

Psilocybin for anorexia

It was great to get a sneak preview from Dr. Natalie Gukasyan about their preliminary impressions from the study for anorexia at Johns Hopkins. I often point out when I speak about eating disorders that anorexia nervosa has the highest mortality of any psychiatric illness, and there's an urgent need for new treatment options. Dr. Gukasyan noted that many individuals with anorexia experience lower-than-expected subjective effects of psilocybin. She mentioned that optimal psychedelic study design for anorexia may need more than the typical two or three dosing sessions that are written into most protocols. Not surprisingly, some individuals with anorexia may need more psychological support than is needed for other conditions—an important reminder that change takes time. These observations and ongoing studies are a great addition to our growing understanding of how psychedelics might help treat anorexia. More research to come.

Can we use psychedelics to reopen critical periods?

Another fascinating topic was Dr. Gul Dolen’s talk on psychedelics and metaplasticity. In their study, Dr. Dolen and her team set out to answer the question: “Can we use psychedelics to reopen critical periods?” A critical period—also called neuroplasticity—is a duration in which a person’s brain is more receptive to the influence of experience and external stimuli. And the answer, for both the classic psychedelics and other compounds like MDMA and ketamine, was not only fascinating, but has relevance for how we approach psychedelic therapy clinically. Different psychedelics vary dramatically in their acute subjective effects, and there’s evidence that the duration of these effects is proportional to the duration of therapeutic effects and the window of neuroplasticity.

For example, ibogaine's subjective effects last 26-72 hours, and ibogaine opens the social reward learning critical period (a period of increased brain plasticity, sensitivity to environmental stimuli, and adaptability) for >4 weeks. Compare this to other drugs, such as ketamine, and you can see a proportionality. Ketamine acts rapidly, but the effects don’t last as long. The acute subjective effects of ketamine last only .5-2 hours, and the social reward learning critical period is open for much shorter, at 48 hours. The critical period of psilocybin and MDMA is two weeks, and for LSD, it’s about three weeks.

"What I think we might have actually discovered is that psychedelics might be that master key for reopening critical periods." – Dr. Gul Dolen

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Concluding thoughts

As a final note, I’ll quote Dr. Matthew Johnson: "One of the reasons psychedelic therapy works so well is people are doing their own healing—there's nothing 'automatic' about it."

These drugs aren’t magic, fix-all solutions. They're powerful tools we can use to do deeper work and to become more aware of ourselves and the world we’re a part of. The process of psychedelic therapy and integration is difficult, but incredibly rewarding work that requires bravery and openness. There truly isn’t anything “automatic” or “easy” about it.

I’m extremely grateful for the contributions that have been made by so many in this field. We’ve come a long way, and I’m excited to see what we can accomplish going forward.

How To Get the Most Out of Your Psychedelic Experience

by Reid Robison, MD MBA

It’s now well-established that set and setting are some of the most important factors in the psychedelic experience. ‘Set’ refers to one's mindset, and ‘setting’ refers to the physical or social environment in which the experience takes place.

The history of set and setting

The term ‘set and setting’ formally entered the psychedelic lexicon on September 9th, 1961 when Harvard researcher Timothy Leary presented a paper on the topic at the annual meeting of the American Psychological Association. Leary posited that set and setting is the most important determinant of the contents of psychedelic experiences.

In his psychedelic research throughout the 1960’s, Leary often spoke and wrote about how the mental state and physical environment of study participants influenced the outcomes. In 1966, Timothy Leary conducted a series of experiments with dimethyltryptamine (DMT) in a controlled set and setting. The aim was to see whether DMT, which researchers assumed was a terror-inducing drug, could produce pleasant experiences under a supportive set and setting. It was found that it could.

The idea of set and setting, however, has been around for much longer than 1966. Centuries before psychedelic research began, the cultural importance of set and setting was established through ritualistic psychedelic use. Shamans from Indigenous tribes in the Amazon guided the set and setting of ayahuasca ceremonies by drumming, singing, and blowing tobacco smoke. These rituals established an attitude of sacredness, acknowledging that the ceremony itself is as important as the effects induced by the plant medicine.

In the eastern hemisphere, similar ceremonies existed with the Soma drinks of ancient Hindu rituals. Though we have limited knowledge about the contents of the drink, ancient texts explain that these rituals involved multiple sacred fireplaces and priests reciting long sequences of mantras and hymns from their texts.

After observing  the Indigenous mushroom ceremonies in Mexico, Al Hubbard (the “Johnny Appleseed of LSD”) adopted the use of set and setting in his psychedelic research trials. When he returned home, Hubbard created a “treatment space decorated to feel more like a home than a hospital.” Hubbard helped other researchers to move away from emphasis on the drug alone.

Set

When psychedelic medicine opens the door to the unconscious, vast spectrums of possibilities emerge. How one steers through the journey depends, in large part, on our set, or the contents of our personal unconscious.

If you have strong walls of conditioning, this may influence how freely you can move through the various vistas of the journey. Similarly, your values, attitudes, hopes and dreams will influence the direction of your attention and play into how you deal with all that subconscious material you encounter.

It’s also important to assess the state of your nervous system while going into the experience. Often, psychedelics function as amplifiers of our subconscious material and mental processes.

Setting

Setting includes physical components like the space you’re in or the music playing in the background. It also includes social factors, such as the people around, or cultural influences which aren’t necessarily visible.

A setting that is calming, natural and inspiring can help point your journey in a direction of positive transformation, just like a grounded, compassionate, and fully present guide can provide a stable energy field that helps you feel centered and safe.

Long-lasting changes

Psychedelics, while not for everyone, can be powerful therapy accelerators and “way-showers.” In other words, they can help us see past those heavy walls of conditioning, the ego defenses, the past wounds, and the illusion of separation that keeps our surface mind from the core of our being and our real Self.

While psychedelics show the way forward, old habits and traits can rapidly snap back into place unless one is committed to doing the work. There is a grace period following profound psychedelic experiences—a window of neuroplasticity that opens and allows changes to happen more easily.

Integration is the process of digesting that change and manifesting its fullest expression. To quote Jack Kornfield, “after the ecstasy, the laundry.”

Anyone who has backpacked around the world or done extensive traveling knows that returning home can be a shock to the system. It can take months for you to adjust to being “back home.” You’ve had all these incredible experiences in that time and it changed you, but the life, the people, and the circumstances you’re returning to appear to be basically the same. They’ve been simply living out their regular lives. It takes time to adjust the “new you” to your life and your life to the “new you.”

It's similar with psychedelic experiences. You’ve gone on a consciousness world-tour or experienced eternity in a night, and now you’re expected to go back to the office on Monday and make small talk with co-workers? This can be very jarring to the psyche and sometimes results in quite a bit of emotional turbulence. Making your integration process a priority is key to integrating the wisdom, insights, and experience in a more conscious and intentional manner. It’s like bringing back seeds from a voyage to the jungle. Now we need to plant, nourish, and care for them.

If you make no effort afterwards to change undesirable patterns, habits of the past tend to reassert themselves and you might find yourself sliding back into your old self. In fact, it can even at times feel worse than before. After you’ve seen the way things can be better, you might feel disappointed to stumble around again in the same old muck.

All that said, when used responsibly and with good intention, skill, integrity and support, psychedelics have the potential to contribute in a major way to easing the pain and suffering in the world by giving us access to more wisdom, compassion, and spiritual development.

About the author

Reid Robison, MDA MBA is the Chief Medical Officer at Novamind. He is a board-certified psychiatrist who was named Best Psychiatrist in Utah by Salt Lake City Weekly’s Best of Utah Body & Mind 2020.

Dr. Robison is the co-founder of Cedar Psychiatry and serves as the Medical Director for the Center for Change, a leading Eating Disorder center. He was previously a coordinating investigator for the MAPS-sponsored MDMA-assisted psychotherapy study of eating disorders.

MAPS Examining the Psychedelic Renaissance - Season 2 Episode 10 with Drs. Reid Robison & Adele Lafrance

Episode 10: Psychedelic-Assisted Psychotherapy for Eating Disorders and Cognitive Behavioural Therapies for PTSD + MDMA

Episode Summary: Hear from the MAPS Researchers. In this episode we will get to hear from some of the leading experts in the field of clinical psychedelic research. Both Dr. Adele Lafrance and Dr. Reid Robison are currently focussed on a study looking at using MDMA to treat PTSD. While Dr. Anne Wagner also has a background investigating Eating Disorders, she will be touching on her work with MDMA + Cognitive Processing Therapy.

Exclusive Post Webinar Sessions:    (Exclusive Post-Webinar Session Details:  Session take place in a private zoom room with the speaker and 6-10 other participants. Limited Capacity. Zoom links sent out the day of the event.  6:30-7:30PM PST, Tuesdays (following the speaker’s episode).  Webinar attendance is not mandatory; however all passes include 1 complimentary ticket to the entire series! 

  • Join Adele and Reid for an Exclusive Q&A. Reid is currently the coordinating investigator for the MAPS-sponsored study MDMA assisted psychotherapy study of eating disorders, and Adele is the clinical investigator and strategy lead for the MAPS-sponsored MDMA-assisted psychotherapy study for eating disorders. This is your chance to meet with the two of them and have all of your questions answered in a semi-private session. To register, see Ep 10Ex: Exclusive w/ Adele & Reid.

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New Research Behind Ketamine’s Molecular Process

At Numinus, we’ve watched ketamine help our patients, and we’re witnessing it change the landscape of psychiatry for good. Compared to traditional medications, ketamine has rapid antidepressant effects, often evident within an hour. For people with treatment-resistant depression, ketamine has shown 50-70% response rates. And we know that here at Cedar. We’ve seen it.

Scientists are rushing to understand the molecular process that makes ketamine so fast-acting and effective. This new research from Sweden focuses on serotonin, which has long been implicated in depression. Researchers studied a specific serotonin binding site and found that after ketamine treatment, patients had an increase in serotonin 1b receptors. While this illuminates a particular aspect of the molecular mechanisms behind ketamine’s efficacy, the total process is still evolving. Concluding the study, the scientists called for more research to help us understand this powerfully therapeutic drug.

We know intimately the low clinical response rates and delayed onset of action of traditional antidepressants, and while they help for some, others need alternatives. That’s why new treatment options are vital. It’s why we stay up to date on current studies and host research of emerging neuropsychiatric treatments—it’s why our Principal Investigator and founder Reid Robison MD MBA has led over 100 clinical trials.

Call us anytime at 1-833-NUMINUS (686-4687), we’re here to help.