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Rethinking therapeutic strategies for Anorexia Nervosa: Insights from psychedelic medicine*

Claire Foldi, Paul Liknaitzky, Martin Williams, Brian Oldfield

Anorexia nervosa (AN) has the highest mortality rate of any psychiatric disease, yet available pharmacological treatments are largely ineffective due, in part, to an inadequate understanding of the neurobiological drivers that underpin the condition. The recent resurgence of research into the clinical applications of psychedelic medicine for a range of mental disorders has highlighted the potential for classical psychedelics, including psilocybin, to alleviate symptoms of AN that relate to serotonergic signaling and cognitive inflexibility. Clinical trials using psychedelics in treatment-resistant depression have shown promising outcomes, although these studies are unable to circumvent some methodological biases. The first clinical trial to use psilocybin in patients with AN commenced in 2019, necessitating a better understanding of the neurobiological mechanisms through which psychedelics act. Animal models are beneficial in this respect, allowing for detailed scrutiny of brain function and behavior and the potential to study pharmacology without the confounds of expectancy and bias that are impossible to control for in patient populations. We argue that studies investigating the neurobiological effects of psychedelics in animal models, including the activity-based anorexia (ABA) rodent model, are particularly important to inform clinical applications, including the subpopulations of patients that may benefit most from psychedelic medicine.

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The resurgence of psychedelic medicine and therapeutic potential for AN

Psychedelics were first investigated as therapeutic agents for mental disorders in the 1950s and more than 1000 clinical papers were published on classical psychedelics between 1950 and the mid-1960s. However, political concerns over widespread non-clinical use and governmental interventions associated with an emerging counter culture led to regulatory obstacles and an abrupt end to this promising research. Recently, a resurgence of research into the clinical application of psychedelics has emerged and clinical trials have already highlighted psychedelic medicine as a promising alternative to conventional methods in what is being hailed as a “paradigm shift” for the treatment of psychiatric disorders, including depression, post-traumatic stress and substance use disorders. In addition, the U.S. Food and Drug Administration (FDA) have twice designated psilocybin for treatment-resistant depression as a “breakthrough therapy,” in 2018 and 2019. Combined with specialized psychotherapy, psilocybin has been shown to decrease symptoms of anxiety and depression that accompany life-threatening cancer diagnoses, alleviate symptoms in patients with treatment-resistant depression, and improve adherence to abstinence regimes in nicotine-dependent smokers. Moreover, patients with obsessive-compulsive disorder (OCD) have shown short-term improvements following psilocybin treatment.

Multiple studies investigating the safety and efficacy of psilocybin for the treatment of major depressive disorder have recently commenced across the U.S. and Europe. Importantly, the first Phase 1 study exploring the safety and efficacy of psilocybin in patients with AN was launched in 2019 to examine a range of outcome measures including self-reported anxiety, depression and quality of life as well as changes in body mass index (BMI) and food preference. The findings from this trial will indicate efficacy one way or the other; however, understanding the biological mechanisms that underpin any effects of psilocybin on AN await carefully controlled clinical and animal-based studies. It should be noted that preliminary support for the efficacy of psychedelics on eating disorder symptoms has been shown in qualitative interviews with patients following the ceremonial consumption of ayahuasca, another serotonergic psychedelic.

An important consideration when interpreting the findings from clinical trials using psychedelics is the inability to circumvent certain methodological biases. Even when niacin or very low dose psychedelics are used as active placebos, most participants and therapists are quickly unblinded to the condition, potentially resulting in expectancy biases. The subjective scales used to measure the efficacy of psilocybin in some studies introduces further bias in the assessment of outcome measures. Irrespective of these limitations, the neurobiological “mechanisms” underlying the efficacy of psychedelics for treatment-resistant depression are beginning to be elucidated in very broad terms through administration of psilocybin in combination with brain imaging techniques. The insights with the most experimental support include alterations in activity and functional connectivity within the default mode network (DMN), a group of neural structures that represent resting-state cognition. Functional connectivity between the DMN and other resting state networks is generally shown to increase following administration of psilocybin, and unusual levels of co-activation between DMN and task-positive structures has been found under psilocybin and ayahuasca. The mechanisms underlying the action of psilocybin on functional activity in resting state networks remain poorly understood, particularly the role of the serotonergic system, considering that the major midbrain nucleus in which 5-HT cell bodies lie is not included in canonical resting state networks. Regardless, mechanistic models have been developed that assert the action of psychedelics as relaxing high-level prior beliefs and liberating bottom-up information flow, and progress is being made to explain the action of psychedelics in the context of complicated neurotransmitter pharmacology, molecular pathways, and plastic changes that contribute to the central actions of these compounds.

Anorexia nervosa (AN) has the highest mortality rate of any psychiatric disorder and is characterized by a relentless pursuit of weight loss despite severe emaciation. The majority of patients with AN also engage in excessive physical exercise and other compulsive locomotor strategies to avoid or counteract weight gain. A number of brain imaging studies in AN point to a combination of decreased neural activity in ventral reward regions and increased neural activity in prefrontal control regions. This imbalance may underlie the rigid adherence to punishing diet and exercise regimes by patients with AN that is characterized by both excessive behavioral control and diminished cognitive flexibility. Despite the high mortality and the array of pharmacological and psychotherapeutic strategies that have been employed to treat AN, up to 50% of AN patients suffer with chronic, often life-long illness, indicating that therapeutic strategies remain inadequate in treating the core symptoms of the disorder. In this respect, psychedelic medicine in combination with specialized psychotherapy represents a novel therapeutic strategy to treat disorders such as AN where treatment options have historically languished.

The purpose of this review is to highlight the potential suitability of psychedelic medicine for improving long-term treatment outcomes in AN, based on what is known about 5-HT signaling and cognitive function in patients and animal models. Although much of our argument is likely to be applicable to the therapeutic potential of other serotonergic or “classical” psychedelic compounds, including LSD and ayahuasca, we focus here on psilocybin for three reasons: (1) the two FDA designations as a “breakthrough therapy” for treatment-resistant depression; (2) its prevailing use in numerous clinical trials for mental disorders; and therefore (3) the proximity to approval as the first widely used psychedelic in medicine and therapy. Further, we argue that fundamental research in animal models is necessary to reach a comprehensive understanding of the therapeutic effects of psychedelics in psychiatric disease. This is no different to the genesis and clinical acceptance of virtually every other pharmaceutical approach; however, in this instance the use of animal experimentation has the profound advantage of eliminating context and expectation that introduce confounds in the understanding of the neurobiological and pharmacological actions of psychedelic compounds.

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The neurobiological actions of psilocybin and relevance to AN

Although it is well known that psilocybin, or more specifically its active metabolite, psilocin, acts as an agonist at multiple serotonergic sites, including the 5-HT2A, 5-HT1A, and 5-HT2C receptors, focus has centered on the 5-HT2A receptor binding profile of psilocin due to the finding that specific 5-HT2A antagonists (e.g., ketanserin) block the majority of subjective effects of the drug in human subjects and psilocybin-induced discrimination learning in mice. Psilocybin intake results in dose-dependent occupancy of the 5-HT2A receptor in the human brain, and both plasma psilocin levels and 5-HT2A binding are closely associated with subjective ratings of the intensity of psychedelic experiences.

The other major neurobiological action of psilocybin administration is to decrease activity and functional connectivity within the DMN, a resting state network that is activated during higher-order cognitive tasks, such as considerations of past and future, self-referential cognition as well as personal, social and moral judgments or decision-making. Interestingly, resting state functional connectivity between the executive control network (ECN), a task-positive network primarily involved in cognitive control and emotional processing, and the anterior cingulate cortex is decreased in drug-naïve adolescents developing AN compared to healthy controls. During demanding cognitive tasks, the ECN typically shows increased activation, whereas the DMN shows decreased activation. Moreover, the insula, a brain region that plays a critical role in switching between the ECN and DMN in divergent thinking shows disrupted connectivity in patients with AN. Accordingly, it may be that psilocybin could act to shift cognitive processing away from an excessive internal focus and toward a more appropriate contextual balance. This style of information processing can more easily adapt to changing environmental needs, perhaps addressing aspects of cognitive inflexibility in patients with AN.

Effects of psilocybin in animal models

The behavioral effects of psilocybin in animal models appear to be mediated primarily through agonism of the 5-HT2A receptor, because the primary behavioral readout in response to psychedelics in rodents, the head-twitch response (HTR), is absent in mice lacking the 5-HT2AR gene. The other most frequent unconditioned behavioral responses to psychedelics in rodents are disruptions to sensorimotor gating (PPI) and exploratory behavior. Psilocybin also impacts associative learning in animal models by preventing rats from acquiring conditioned avoidance responses and producing more rapid extinction of conditioned fear responses in mice. In addition, psilocybin has been shown to induce dopamine (DA) release in the nucleus accumbens (part of the ventral striatum) and increase extracellular 5-HT levels in the medial prefrontal cortex in rats. This finding is tantalizingly consistent with the proposal that psilocybin could alleviate anorexic symptoms in the ABA model, not only because 5-HT signaling is reduced during ABA, but also because selective activation of DA projections to the nucleus accumbens prevents and rescues the ABA phenotype.

Studies investigating the therapeutic potential of psilocybin in animal models of psychiatric disease have demonstrated significant alleviation of symptoms in mouse models of OCD and PTSD, but did not significantly reduce anxiety phenotypes in wildtype rats or depression-related behavior in a genetic rat model, the Flinders Sensitive Line (FSL). There are several reasons why the significant abatement of depression and anxiety symptoms in human clinical trials was not replicated in these animal studies. It may be that the behavioral test of depression in rodents, the Forced Swim Test (FST), does not fully capture the pathological state of major depressive disorder that is amenable to psilocybin treatment. The FST was originally developed as an antidepressant drug screen and aided the discovery of multiple drugs used successfully in the treatment of clinical depression. However, the behavior of rats and mice in this test is influenced by a number of factors including stress and activity levels, and immobility in this task has been suggested to reflect both adaptive behavior as well as despair. Similarly, although FSL rats are shown to respond to traditional antidepressant medications, they also have markedly lower expression of 5-HT2A receptor mRNA in the frontal cortex, indicating that perhaps the 5-HT2A-mediated effects of psilocybin may have a blunted response in these animals, driven by an inability to bind. This study did not examine the impact of psilocybin on brain function or receptor-specific activity, so whether depressive phenotypes in the FSL model correlate with altered 5-HT2A signaling remains to be resolved.

It is also likely that at least part of the impact of psilocybin on treatment-resistant depression in clinical trials is driven by the higher order subjective characteristics of psychedelic-assisted therapy and the known role of context in the efficacy of psychedelics. Indeed, certain subjective effects are shown to be critical for long-term clinical outcomes across multiple trials. Regardless, it remains the case that ethologically relevant animal models with specific neurobiological and behavioral features that are known to be amenable to the neurobiological impacts of psilocybin will provide unique insight into the therapeutic potential of psychedelics. One example is the ABA model, that displays both cognitive rigidity and disrupted 5-HT function analogous to the human condition. Such studies should test cognitive function in comparable ways to human cognitive test batteries, differentiate effects of single dose administration versus repeated dosing and investigate the impact of non-psychedelic 5-HT2A agonists to challenge the specificity of the effects of psilocybin on behavior and brain function.

Summary and conclusion

Recent clinical trials have put the spotlight on the therapeutic potential of psychedelics, specifically psilocybin, for a range of psychiatric disorders. The neurobiological and behavioral phenotype of AN, specifically with respect to modified serotonergic signaling and cognitive inflexibility, is well-positioned to be impacted by the putative effects of psilocybin treatment. New treatment strategies for AN are urgently needed, considering that up to 50% of patients with AN never recover, and the risk of death in patients with AN is more than five times higher than in the general population. Converging evidence suggests that psilocybin may be a promising novel treatment for AN, and well-designed trials including those in established animal models are warranted.

Surprisingly, beyond animal testing for safety and tolerability, the psychedelic research model has thus far largely bypassed the comprehensive screening of drug effects in animal models that usually punctuates the drug discovery pipeline to clinical trials in human patients. This may be based on the premise that psychedelic drugs will not impact animals in the same way as humans because of the uniqueness of the notable phenomenology in humans. Regardless, certain underlying neurobiological effects of psychedelics on cognitive function can be interrogated in animal models with much greater specificity than in human subjects. Animal models of disease also allow determination of the neurobiological effects of psychedelic drugs without the confounds of expectancy and bias that are impossible to control for in patient populations. They have been used successfully over many decades to enable rational pharmacology and the development of more targeted and efficacious medications.

The knowledge gained from animal studies of psychedelic medicines will add substantially to mechanistic accounts of clinical treatments for humans, and may afford improvements and innovations in clinical treatment. The important contribution that animal models can make in progressing the understanding (and possibly development) of psychedelic medicine as a viable therapeutic approach to some mental disorders is in the detailed scrutiny of brain function and behavior they provide. This aligns with a well-worn path whereby detailed mechanistic insights enable rational drug design. However, there is another less tangible benefit that may arise from a better, experimentally based understanding of the actions of psilocybin; reducing stigma associated with the use of psychedelics in a clinical setting. Across a wide range of community attitudes and social bias, it is increasingly recognized that education and understanding are key elements in dismantling stigma. Specifically, a reductionist understanding of the brain circuitry and neurochemistry that mediate the central effects of psychedelic medicines – independent of the confounds of human expectations and context – will help to demystify their clinical effects and hopefully diminish the prejudice associated with their use in the treatment of psychiatric disorders such as AN.

*From the article here :
 
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Are psychedelics the future of anorexia treatment?*

by Tessa Love | elemental | Nov 6 2019

A new trial by Johns Hopkins Medicine will study the effectiveness of psilocybin for eating disorder treatment

In early September, the burgeoning field of psychedelic research got a long-sought-after dose of legitimacy: Johns Hopkins Medicine received $17 million in funding to launch the Center for Psychedelic and Consciousness Research. A first-of-its-kind facility for the United States, the center will study the efficacy of psychedelics — namely psilocybin (otherwise known as psychedelic mushrooms) — as a treatment for a range of mental health disorders. While much of the existing research around psychedelics and mental health focuses on the drugs’ ability to treat PTSD, depression, and addiction, the launch of the center brings a new and less-expected line of research: psychedelics as a treatment for anorexia nervosa.

Anorexia, as it’s more commonly known, is a mental illness affecting some 30 million Americans that manifests as an eating disorder, characterized by abnormally low body weight, body image distortion, and a fear of gaining weight. People with the condition often go to extreme measures to control their weight and eating habits, which can be dangerous: Complications from the disease can include heart problems, bone loss, anemia, and even death.

In fact, anorexia nervosa is responsible for more deaths than any other mental illness. This is due, in part, to the physically degrading nature of the illness, but it’s also attributable to the fact that medical professionals have yet to find an effective treatment for the disorder. As of now, the accepted treatment consists of supervised weight gain coupled with cognitive behavioral therapy (CBT), which aims to challenge and change the thinking and behaviors behind the issue. The relapse rate for the treatment is up to 52%, according to a 2017 review.

Given psilocybin’s track record of treating people with other treatment-resistant mental health disorders, researchers at Johns Hopkins are cautiously hopeful that it could be the answer, and the team is in the recruiting phase of a landmark clinical trial to explore the possibility. The study will likely take two to three years to complete, from recruitment to analysis, but the trial itself will take about eight months.

In structure, the trial will look similar to the psilocybin trials Johns Hopkins has completed in the past for other disorders. After a month-long prep period, people in the study will have two psilocybin sessions two weeks apart, lasting six to eight hours each. The dose for the first session will be 20 milligrams (considered a typical dose for inducing a psychedelic experience) and the second dose will be either 20 or 25 milligrams, depending on the experience of the first session.Though counselors are present, these sessions aren’t therapy-like. Instead, people are encouraged to “go inside” their minds and “be with their internal experience,” says Natalie Gukasyan, a post-doctoral research fellow at Johns Hopkins’ psychedelic research unit.

“It’s really a complicated illness, and we really don’t know what’s going to happen in the laboratory when we give folks like this psilocybin. But we’re hoping it can be helpful.”

The sessions are followed by a next-day follow-up, then another follow-up a week later to discuss the experience. After the second session, people in the study will have a month-long “integration period,” where counselors help them integrate their psilocybin experiences into their understanding of their disease. The therapy will be based on motivational interviewing, a counseling method that aims to help people find the internal motivation to change behaviors by resolving insecurities. Finally, the people in the study will have a follow-up six months later to determine the effectiveness of the intervention on the eating disorder.

Though this is the first study that will examine psilocybin as a treatment for anorexia, early research with other psychedelics has suggested promise. A 2017 study interviewed 16 people with eating disorders who had participated in an ayahuasca ceremony, which involves drinking a psychedelic brew from the Amazon. Eleven of the people reported that the experience led to reductions in their symptoms, and 14 said the drug made them better able to regulate their emotional state. There are also several first-person accounts of people using psychedelics to help heal eating disorders.

In a 2013 review examining the failure of treatment options for eating disorders, researchers concluded that the resistance to treatment stemmed from the “ego-syntonic” nature of the illness, meaning many of the behaviors, values, and feelings behind the symptoms of the disease stem from the needs and goals of the ego. Dissolving the ego happens to be a hallmark of the psychedelic experience: In this altered state, people are often able to gain a new perspective on themselves in the world. If psilocybin works for eating disorders, researchers believe this may be the reason.

More often than not, people diagnosed with anorexia have other mental health conditions, according to Gukasyan, which means even if the psilocybin treatments don’t treat the disease directly, the experience could still be effective for the person’s overall mental health. “It tends to be more the rule than the exception that someone with anorexia is also struggling with anxiety, depression, OCD, or have some sort of trauma-related problems,” she says.

Though anorexia nervosa is classified as a mental illness, research is increasingly showing that there are physiological components to the disease as well, which, according to Gukasyan, means that “there are things that happen in the body chemically that keep people stuck in the patterns of starvation and excessive exercise. This includes hormone changes and potentially even genetics, as anorexia is often hereditary." Gukasyan is unsure of whether the psilocybin intervention can help address these physical aspects, but believes the trial is still worth a shot.

“It’s really a complicated illness,” she says. “And we really don’t know what’s going to happen in the laboratory when we give folks like this psilocybin. But we’re hoping it can be helpful.”

From the article here :
 
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What psychedelics could mean for eating disorders

by Justin Hampton | LUCID | 18 Aug 2020

Chrissy Sandwen’s final wake-up call for her binge-eating disorder came in an unforgettably putrid yet poetic form. All-too-familiar waves of depression and anxiety became magnified during an extended and profoundly lonely stint as a social worker in rural Costa Rica. To top it off, Sandwen found herself overwhelmed by uncontrollable binge-eating episodes, which ignited feelings of self-loathing.

“It felt like my body had been taken over by a demon,” Sandwen recalls. After a friend’s ill-advised decision to flush paper down Sandwen’s toilet led to a sewage flood in her apartment, the ensuing detonation morphed into a teachable moment. “I was like, ‘This is a fucking metaphor for my life. I’m a beautiful, incredible, amazing person, but I am ankle-deep in my own fucking shit.’”

A few days later, Sandwen learned about an ayahuasca retreat near her through Google. From there began a nonlinear, yet ultimately rewarding, path to healing currently being contemplated by a unique subset of those who study and those who struggle with eating disorders.

Between the antipodes of anorexia nervosa, whose sufferers compulsively pursue weight loss through various mortifications, to the endless binge-and-purge cycles of bulimia nervosa lies a spectrum of variants, all characterized by unique combinations of self-destructive eating behaviors, and one can transform into another within the same person over time. Relapses are common, dropout rates are high, and while recoveries are achievable, an estimated 50% of those with anorexia will live with their illnesses for the rest of their lives. In the worst case scenario, an estimated 10% of anorexics will die from their disease. Short of opioid addiction, eating disorders writ large are considered the most fatal mental health disorder, a grim statistic ED specialists live with daily.

Enter psychedelics, which hold the potential to unravel many of the comorbid mental illnesses, such as depression, anxiety and obsessive-compulsive disorder, underpinning many eating disorders. For psychologist Adele Lafrance, who learned about ayahuasca’s therapeutic effects after two patients at an eating disorder treatment center where she worked died, psychedelic and psychedelic-adjacent medicines such as psilocybin, MDMA and ketamine may extend a powerful lifeline to the most refractory of cases. “Though some of our treatments work well for some people, there’s a significant number of individuals who really continue to struggle,” she says.

Previously unfamiliar with psychedelic medicine, Lafrance watched a documentary about Vancouver physician Gabor Maté’s work with ayahuasca, and eventually reached out to him personally. Encouraged by what she learned, she later co-wrote a paper on the impact of ceremonial ayahuasca experiences on the eating disorders of 13 women in 2018. Since then, academic and independent researchers alike have followed in her wake.

A Johns Hopkins University study on anorexia nervosa and psilocybin briefly began volunteer intake before it was paused by COVID. (In the meantime, it is still recruiting for patients, according to Johns Hopkins psychiatrist Natalie Gukasyan). Imperial College will embark upon its own 20-patient anorexia/psilocybin study early next year, COVID permitting. MAPS is preparing its own MDMA-assisted study for the treatment of anorexia nervosa and binge-eating disorder. At the University of California-San Diego, researchers Stephanie Knatz and Walter Kaye are finalizing the funding for a safety and tolerability study on psilocybin and its effects on psychopathology, anxiety, depression and weight in anorexia. And Lafrance is currently undertaking an independent study with Utah psychiatrist Reid Robison to pair ketamine with a treatment modality she calls emotion-focused ketamine-assisted psychotherapy for anorexia nervosa at Cedar Psychiatry.

Researchers anticipate each psychedelic serving different purposes in treatment. Ketamine’s fast-acting relief on depression has led to the FDA approval of the closely-related esketamine, and Robison acknowledges its usefulness in treating the depression of eating disordered patients. Robison also points to ketamine’s ability to afford “the individual a time-out from what some might call the ordinary mind… to see the forest for the trees.”

Classical psychedelics like psilocybin have interested clinical psychiatrist Timothy Brewerton for decades due to their activity on serotonin broadly, and the 5-HT2A receptor specifically. ”Serotonin dysregulation can be linked to all of these co-occurring phenomena that we see associated with eating disorders,” he says, referring to OCD and other disorders that fall on the impulsivity-compulsivity spectrum, as well as suicide. “Psilocybin binds very tightly to these 5-HT2 receptors. These drugs appear to have an effect on cognitive rigidity, which is certainly seen in anorexia and in the eating disorder spectrum of disorders.”

As for MDMA, Brewerton has co-written an as-yet unpublished paper with Lafrance on the potential treatment of people diagnosed with eating disorders and PTSD with MDMA. For a “significant portion of people with EDs, trauma is the rule rather than the exception,” says Brewerton. “I think it’s a major factor in severe and enduring eating disorder stories. Those are the ones who don’t get better because they still have undigested, unresolved trauma issues.”

“If I was a betting man,”
Brewerton adds, “I’d say psilocybin is going to be more powerful for anorexia and MDMA will be more powerful for those who have PTSD.”

Unfortunately, psychedelics share a strong cultural stigma with eating disorders, which Brewerton has confronted throughout his career within the ED community. “Lafrance and I proposed a workshop two years ago by [the Association of Eating Disorders] and it was rejected. She has proposed other workshops on her own. They have been rejected,” he says. “There’s stigma to being involved with this research because of preconceived notions.” However, he does believe the stigma will fade with an expanded research base. Robison has already noticed a shift in public opinion. “Every time I speak about psychedelics and eating disorders or in other conditions, I’m always very pleasantly surprised and hopeful because of how welcome they are by the individuals and families,” he says.

In the meantime, a vocal subset of the eating disordered have moved forward on their own, taking their stories to the internet, integration circles and therapists in the absence of standardized treatments. After entering Brown University in 2014, Kylie Fustini began with food restriction and moved onto purging after meals. This was augmented by fat-burning pills and an aggressive focus on her calorie count. Fustini moved from bouts of severe food restriction and excessive exercising toward more purging episodes throughout 2015, and smoked weed “as a way to both manage my anxiety and be disconnected from my body.” Finally, in 2016, she took leave from Brown for three-and-a-half years to treat her eating disorders.

During this time, she self-treated with LSD and mushrooms, and integrated with a therapist. Like Sandwen, Fustini’s experiences have put her on the path to becoming a psychedelic-assisted therapist. “Having healed the way I did from psychedelics, after trying out western medicine, being on various prescribed meds, trying cognitive behavioral therapy, and still just not really making much progress, I am a huge advocate for the therapeutic uses of psychedelics,” she says. “Tripping helped me to get in touch with my soul, and recognize that my body was just a vessel and to not be so cruel to it.” Meg Spriggs, a neuroscientist coordinating the Imperial feasibility study, notes a similar phenomenon in Imperial’s psilocybin/depression trials. “Anorexia is not kind and it’s not very loving. [That’s] something we see in our depression trials, people being able to connect with… that feeling and that love,” says Spriggs.

However, both Sandwen and Fustini say that psychedelics only took them so far. After a welcome pause following her first ayahuasca journey, Sandwen reports her binge-eating returned “with a vengeance,” and was even exacerbated by a mushroom microdosing regimen.

Carol Kan, a ketamine researcher currently preparing a fellowship on ketamine and anorexia, recently conducted a survey to assess how people with eating disorders felt about alternative therapies. Preliminary findings show that less than a third of the eating disordered would resist psychedelic-assisted treatment under any circumstance, and there was a moderate level of concern among the whole group studied.

Fustini says that a more extensive and informed administration of her psychedelic experience would have helped with her treatment: “While my therapist was rather open-minded, she has never had a psychedelic experience and I feel that she could not fully understand what I was going through on these trips in my healing process.”

Startups in the psychedelic field have been relatively slow to embrace the treatment of eating disorders. An exception is NeonMind, a majority-owned subsidiary of Better Plant Sciences, Inc. (formerly The Yield Growth Corp.), which has filed a preliminary patent application in the U.S. for the use of DMT for compulsive eating disorders. According to William Panenka, Chair of the NeonMind Scientific Advisory Board, "DMT acts on the“same type of serotonin detectors which are known to regulate appetite,” reports Yahoo News.

However, Brewerton remains deeply skeptical of appetite suppressants as treatments for certain eating disorders, psychedelic or otherwise.

“People have looked [at] a whole laundry list of appetite suppressants for the treatment of obesity and binge-type eating disorders, and it’s all a bust. And it’s a bust because people become very rapidly tolerant to the appetite suppressing effects,” Brewerton says. “Back in the 40s after amphetamines were discovered, people were prescribed [them] willy-nilly… And it got a lot of people addicted. It got a lot of people more anxious. It got a lot of people crashing into major mood disorders and suicidality and any appetite-suppressing effects petered out and the people gained all the weight back. So they don’t work and we know that from way back when.”

With or without psychedelics, ED specialists will continue to face daunting challenges in their work. ED research is chronically underfunded, with only $11 million allocated to research by the National Institute of Health, versus $263 million for schizophrenia, according to Science. And while new pharmacological treatments are welcome — Prozac, Vyvanse and Olanzapine are used to treat bulimia, binge-eating disorder and anorexia, respectively — eating disorders are far too complex for any drug to cure it altogether. Sandwen compares her healing process to a “spiral staircase.

“I felt like I was coming up the same spot over and over again, but what I recognized was that it was still a staircase going up,” says Sandwen. “Even if I was still having a problem with eating, I was coming at it from a different level of consciousness every time. Every moment was a way to put it into practice. Psychedelics were a huge component of that.”

 
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Psychedelics improve depression and wellbeing scores in people with eating disorders*

by Alex Criddle, MA | Psychedelic Science Review | 12 Oct 2020

Study provides the first preliminary quantitative exploration of the psychological effects of psychedelics in individuals with a self-reported diagnosis of an eating disorder.

According to the National Eating Disorders Association, eating disorders (ED) affect approximately 9% of individuals in the United States. Currently, the main treatment for eating disorders is cognitive behavioral therapy. This is usually combined with some pharmacological treatment as well. However, these treatments might only be effective for the comorbid conditions that occur with eating disorders such as anorexia nervosa and bulimia nervosa without necessarily being able to treat the eating disorder itself. Because of this, more treatment routes are needed for those individuals with eating disorders. One study conducted by Spriggs et al. suggests that psychedelics may improve depression and wellbeing, aiding in the recovery for individuals with eating disorders.

Study design

In 2020, a prospective, online study was conducted by Spriggs et al. This study used 28 participants who self-reported a lifetime eating disorder. All of the participants were planning on taking a psychedelic drug of some type. Fifty individuals completed the initial survey, but only 28 completed the surveys after their psychedelic drug experience.

All participants completed the Quick Inventory of Depressive Symptomology, a 16-item measure of depressive symptom severity, and the Warwick–Edinburgh Mental Wellbeing Scale, a 14-item scale designed to measure hedonic and eudemonic aspects of positive wellbeing.3 This evaluation was administered 1-2 weeks before and 2 weeks after the participant’s psychedelic experience. Twenty-seven of the 28 participants also completed the Emotional Breakthrough Inventory (EBI) in relation to their psychedelic experience. The EBI is a more recently developed measure of emotional release or breakthrough during psychedelic experiences. Bayesian hypothesis testing was used for the analyses of the measures.

Study findings

Spriggs et al. found that at baseline, nine of the participants scored in the moderate to the very severe range for depression while the group mean score was in the range of mild depression. Two weeks after their psychedelic experience, there were no participants in the moderate-severe range, and the group mean score had dropped below the threshold for having any depression.

The researchers found that the improvements reported on the QIDS-SR16 measure were highly correlated with changes in the WEMWBS scores. This is an important finding because it has been observed that psychological wellbeing and quality of life are lower in those in remission from an eating disorder than the general population. People who recover from eating disorders report positive wellbeing as being central to their recovery. This supports the possible mechanisms through which psychedelic-assisted psychotherapy might be relevant for eating disorders. The researchers also found a weak correlation between EBI and these positive outcomes. Nonetheless, these observations support findings from a prior study on ED and ayahuasca.

Conclusion

While the results of this study require interpreting with caution, the data do provide quantitative evidence for the benefit of psychedelics for eating disorders. Spriggs et al. found that psychedelics were effective in significantly reducing depression and significantly increasing the quality of life for people with ED. This study supports the need for clinical trials studying the effects of psychedelics on individuals with eating disorders.

*From the article here :
 
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Psilocybin and LSD may effective for treating eating disorders*

NEWSFILE | 10 Jun 2020

Psychedelics could rapidly change the way we address obesity and eating disorders.

We already know that major institutions have found such drugs can effectively treat obsessive-compulsive disorder, PTSD, opioid addiction, alcoholism, depression, and anxiety.

Nowadays, we may soon learn they can assist with obesity and eating disorders, too.

That's because psilocybin activates serotonin receptors, or "nature's own appetite suppressant," as noted by Psychology Today. "This powerful brain chemical curbs cravings and shuts off appetite. It makes you feel satisfied even if your stomach is not full. The result is eating less and losing weight."

We may also soon learn LSD may be useful in treating those issues, as well.

Doctors first used LSD to treat issues such as anxiety and depression during the 1950s and 1960s, says Vice.com. While the drug has since been written off, it may soon make a comeback to also help with obesity and eating disorders as well. That's what Yield Growth Corp. majority owned subsidiary NeonMind has set out to prove.

LSD could assist in the treatment of obesity and eating disorders

NeonMind has filed an additional provisional patent application related to using psychedelics as medicine. The patent application covers the administration of a compound selected from the group consisting of lysergic acid diethylamide and d-lysergic acid amide (and compounds with similar molecular structure)in combination with a 5-HT2A antagonist to treat compulsive eating disorder, obesity and related illnesses.

The patent application was filed by NeonMind on June 5, 2020, and Translational Life Sciences Inc. has a 20% interest as a co-collaborator on the development of intellectual property. "Our research with our scientific team into using psilocybin to treat compulsive eating and food cravings has led to paths of inquiry for research into expanded medical uses of psychedelics," says Penny White, NeonMind CEO, "we are excited to lay the groundwork for new areas of potential research for the future."

The global projected market for weight loss and weight management treatment is estimated at USD $245 billion, according to MarketsandMarkets. The global projected market for diabetes treatment is estimated at $87 billion US Dollars, according to Modor Intelligence.

Research and development involving controlled substances such as psilocybin, LSD and LSA in Canada can only be conducted with approval by Health Canada. Section 56 of the Controlled Drug and Substances Act (Canada) grants Health Canada the right to give exemptions for research into controlled substances.

*From the article here :
 
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Johns Hopkins starts psilocybin clinical trial to treat Anorexia Nervosa

by Barb Bauer | PSR | Sep 04 2019

Anorexia has phenomenological parallels to anxiety and addiction, both of which have been shown to improve with psilocybin-assisted interventions.

Scientists at the Psychedelic Research Unit of Johns Hopkins are starting a clinical trial pilot study to evaluate the effects of psilocybin-assisted therapy for treating anorexia nervosa (AN). This study demonstrates the increasing interest in researching the therapeutic applications of psychedelic drugs. The AN clinical trial comes on the heels of the US Food and Drug Administration (FDA) granting breakthrough therapy designation for the psilocybin-assisted therapy clinical trial for treatment-resistant depression that is currently underway.

Anorexia nervosa is an eating disorder primarily affecting women. The condition causes people to obsess about food and their weight. Sufferers usually have a distorted body image, seeing themselves as overweight even though they are often significantly underweight. Complications of AN include heart problems, electrolyte imbalance, bone loss, anemia, and death.

Dr. Natalie Gukasyan, a post-doctoral research fellow at Johns Hopkins, told New Atlas:

"Our goal is to determine whether psilocybin can be safely administered in a supportive setting to people with anorexia nervosa (AN), and whether this intervention can produce improvements in mood, quality of life, and cognitive and behavioral symptoms of the disorder."

Many aspects AN are not fully understood. However, Dr. Gukasyan explains the factors that indicate psilocybin-assisted therapy may be effective for treating AN:

"The pathophysiology of AN remains obscure but some evidence suggests that the serotonin 2A (5-HT2A) receptor system may be involved. The action of psilocin, the active metabolite of psilocybin, is mediated by stimulation of these receptors. AN also shares phenomenological parallels to anxiety and addiction, both of which have been shown to improve with psilocybin-assisted interventions."

According to ClinicalTrials.gov, the pilot study will test about 18 participants and conclude in December 2022. As of August 12, 2019, the study was in the very early stages and not yet recruiting volunteers.

The Future of psilocybin-assisted therapy

Psychedelic drugs such as psilocybin that are found in psychedelic mushrooms (aka magic mushrooms) are clearly poised to change the face of treatment for several mental conditions. However, it is important to remember that psilocybin is only part of the story when it comes to the effects (beneficial or otherwise) of naturally-occurring compounds. Magic mushrooms, for example, contain a cocktail of compounds along with psilocybin including psilocin, baeocystin, norbaeocystin, norpsilocin, and aeruginascin. There are no studies examining how all these compounds work together in the human body to create the overall psychedelic experience (known in medical cannabis research as the entourage effect).

There is no question that psilocybin-assisted therapy is showing great promise. But the question remains, how much better could therapy be if scientists understood the pharmacology of all the magic mushroom compounds and how they work together? Formulating accurate and precise doses of each component allows the development of targeted therapies that may be even more effective and have fewer side effects. Further, healthcare providers could provide more effective treatments for women that take into account their unique pre- and post-menopausal physiology. There is a significant and critical unmet need for understanding the chemical variability in natural compounds like psilocybin mushrooms.

 
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Psilocybin and weight loss*

by Miro Tomoski | DoubleBlind | 6 May 2020

Psilocybin has been fast-tracked by the FDA to become a prescription medication in psychedelic-assisted therapy for depression, but now we’re seeing investors line up to support a new indication for the synthetic compound that’s been made famous—in its organic form—by magic mushrooms. Indeed, there is now a patent pending for psilocybin to be used as a weight loss supplement.

“I think, ultimately, we all believe that patents and science and clinical results will drive the value of companies and efforts to bring this [kind of therapy] forward,” says Jeff Smith, chairman of the board at NeonMind Biosciences, the company looking to develop psilocybin microdoses for weight loss.

Patents are often used by companies to show investors they have the exclusive rights to the product they’re investing in—at least until the patent runs out. When it comes to naturally occurring plants or fungi, however, the patent process becomes a lot more complicated and patent approval is increasingly up to the interpretation of the United States Patent and TradeMark Office.

Psilocybin mushrooms, for example, cannot be patented because they are naturally occurring fungi, but specific uses or methods of extracting psilocybin could be considered unique enough to qualify for a patent.

In December, NeonMind applied for a patent to use psilocybin and psilocin (another compound found in psychedelic mushrooms) for the purpose of overall weight loss by reducing food cravings, curbing impulsive eating, and increasing metabolism, among other indications and in combination with choosing less caloric foods. It’s not a broad monopoly on psychedelic mushrooms of any kind, but the rights to their own method of extracting the active ingredients from the mushrooms as well as their use to regulate weight and treat obesity related illnesses like diabetes.

As far as clinical trials go, the weight loss benefits of psilocybin have not been fully explored. The value of any patent and future products also depends on the success of lab-extracted psilocybin and psilocin used in FDA trials, since they are still highly restricted substances. But there’s no doubt NeonMind is prepared for day one of a legal market for mushrooms as they currently hold the rights to more than 120 unique formulas for beverages and infused foods, including coffee that has been infused with a variety of mushrooms containing psilocybin and psilocin.

NeonMind, formerly known as Flourish Mushroom Labs, is part of The Yield Growth Corp, based in British Columbia, Canada. While they are the only company to seek a patent for psilocybin and psilocin for weight loss, NeonMind is just one part of a larger trend among companies looking to enter the psychedelic space with exclusive access to specific treatments. Most notable, perhaps, has been the patent recently granted to Compass Pathways for the use of psilocybin to treat depression.

“There’s a consumer shift to more natural, better approaches that are based on science,” says Smith, pointing out an increasing trend of patients seeking holistic alternatives to the once-daily pill. As the former chairman of the board at Johnson & Johnson, Smith says he’s even seen big pharma attempt to make the same shift with J&J focused on bringing Spravato, or esketamine (a form of ketamine), into the marketplace for depression. Smith also notes that his move away from one of the largest pharmaceutical companies in the world and into psychedelics was not a quick decision having been particularly inspired by the way in which ketamine helped to treat his brother.

Of course, as Smith left Johnson & Johnson in May of 2019, the company had been dealing with lawsuits for everything from cancer allegedly caused by their talcum powder to the companies role in distributing opioids that contributed to the current crisis. For his part, Smith has shown support for changing the way in which his industry works as early as 2015, arguing for stricter regulations over companies that produce a massive amount of consumer products like J&J.

*From the article here :
 
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Can psychedelics treat eating disorders?

by Marlene Halser | DoubleBlind | 9 Nov 2020

After an ayahuasca ceremony, one ED patient smashed her scale, beginning a journey of healing. Now a number of studies are showing proof that psychedelics could be more promising than traditional treatments.

Lauren Taus went straight for the scale. This time, not to weigh herself, but to grab the slender glass instrument from its centerplace in the bathroom, carry it outside, and haul it to the ground. In a singular gust, the shattered pieces of the scale had scattered throughout the driveway. “It was exhilarating and liberating and energizing and beautiful,” Lauren relays through a big, happy smile, over a Zoom call. It was when the 38-year-old therapist and yoga teacher had done ayahuasca that a spirit entity, which felt like a grandmother, told her to let go of her eating disorder. Immediately after the ceremony, the facilitators lent her a baseball bat and their own scale, encouraging her to smash it—then she went home, and smashed her own. “The relationship to my body has changed since then,” she says.

Lauren is one of the 28.8 million Americans (or nine percent of the population) who experience an eating disorder—including anorexia, binge eating, or bulimia nervosa—in their lifetime. Eating disorders can be lethal, second only to opioid overdose as the deadliest mental illness in the US. More than 10,000 people die each year as a direct result of an eating disorder, either by suicide or by medical complications secondary to the symptoms. That’s one death every 52 minutes.

“I was probably knocking on death’s door for a short period of time,” Lauren says. “I didn’t have my period for a number of years and my parents threatened to take me out of school if I wouldn’t gain weight.” She was 17 when she first started weighing herself obsessively and manipulating her food intake. “I would be crying over the toilet bowl because I just couldn’t purge,” so she started abusing laxatives instead. In college the situation became worse.“I was weighing myself all the time, giong to the gym a lot and dropping weight constantly,” she says. “I was a straight A-student. I was an editor of the college newspaper. I was doing community service. I was thriving from external measurements, but I was dying inside.”

Seeing a therapist and going to 12-Step meetings run by Overeaters Anonymous helped Lauren slowly return to a more healthy way of eating. “The therapist probably saved my life,” she says. But the idea of having to constantly control her weight never entirely left her mind. “Every morning my heart would start racing when I stepped on the scale,” she recalls. “And the number it showed would determine how I was feeling about myself, or if I go out or cancel a date.”

Eating disorders are among the most challenging mental disorders to treat, and long-term outcome studies show high rates of dropout from treatment and relapse rates around 30 percent and higher depending on the eating disorder and the way relapses are measured. Methods including psychotherapy, hospitalization, and medication may ease the symptoms of an eating disorder, especially for those suffering from bulimia nervosa or binge eating disorder. For anorexia nervosa, however, there is no consensus on a first-line psychotherapeutic model or treatment. And up until now, there is nothing that comes even close to a cure.

So no wonder there’s a great deal of excitement and curiosity among psychedelic researchers, who have heard about healing stories like Lauren’s, with the help of ayahuasca. Psychedelics might just hold the key to new forms of treatment, which could potentially transform the lives of eating disorder patients, in ways that have not yet been achievable.

“When it comes to eating disorders and psychedelics, we are in the beginning of a very exciting time,” says clinical psychologist Adèle Lafrance, who is a clinical psychologist and a pioneering researcher in the psychedelic field.

In 2017, Lafrance published her research on ayahuasca and eating disorders, which laid the groundwork for what’s now a slew of studies that are about to start in several universities across Canada, the USA and the UK looking at MDMA, ketamine and psilocybin as potential eating disorder treatments, as well. Her initial study looked at 14 women and two men, 10 suffering from anorexia and six from bulimia. Thirteen of the 16 participants had at some point engaged in conventional eating disorder treatment in either hospitals or other settings with various psychotherapeutic approaches. But these treatments had not led to what participants described as recovery from eating disorder thoughts and behaviors.

“All but one participant reported that the ayahuasca experiences contributed to a greater sense of wellbeing and was beneficial to them with respect to eating disorder thoughts and symptoms,” says Lafrance. Half of the interviewees also reported reductions in anxiety, depression, self-harm, suicidality, and problematic substance use that are often comorbid with an eating disorder.

Some participants reported that the preparatory dieta leading up to the ayahuasca ceremony, which includes restricting one’s intake of meat, sugar, coffee, alcohol and other drugs, was a trigger for well-known thoughts about food restrictions. But the purging (vomiting) aspect of ayahuasca—seemed to be a completely different experience. “It was mostly experienced as a purge of pain fueling the illness,” Lafrance reports, rather than being reminiscent of the purge inherent in disordered “binge-and-purge” bulimic cycles. “One woman, however, shared that she never actually purged in an ayahuasca ceremony, because she was told by the plant spirit that she had vomited enough in her life.”

With the ayahuasca having helped the study subjects to experience deeper, more efficient healing, coupled with feelings of self-love and self-care, they were able to approach their eating disorder from a different vantage point than what traditional treatment could offer. “I think it adds a dimension that is missing [from the Western model], which is this ability to really experience in a very embodied way all of the implicit material that played a role in leading into the formulation of the eating disorder, the wounding that happened,” one participant in Lafrance’s survey explained.

Today, a new and somewhat broader study follows up on Lafrance’s previous work. At the Center for Psychedelic Research at Imperial College London, postdoc Meg J. Spriggs published a study in August looking at various psychedelics in the treatment of depression and overall well being among eating disorder patients. In conducting the study, Spriggs anonymously surveyed 27 participants reporting a lifetime diagnosis of an eating disorder, and who had taken ayahuasca, DMT, 5-MeO-DMT, LSD, 1P-LSD, psilocybin, or San Pedro. The results showed improvements in both symptoms of depression, as well as in general well being two weeks after a psychedelic experience. While no firm conclusions could be drawn, Spriggs writes, the evidence shows the potential for psychedelic-assisted psychotherapy as an eating disorder treatment, and the need for more clinical trials.

“That night, I laid down after drinking the first cup [of ayahuasca],” Lauren says, describing the experience that changed her life. “My body was shaking and I remember judging the way my thighs felt shaking. Then I saw a woman in a gray dress who points at my thighs, looks at me and says: What’s your problem? I made those! So I feel a bit childlike, punished and ashamed and I am like: Oh! Sorry! I should not complain about your handiwork.” Then Lauren describes her vision of the woman going about her body, doing “house cleaning.” “I am uncomfortable with the cleaning. I don’t like it. But she’s like: Come! Come clean with me. You asked for this,” Lauren recalls. “So I would join her in the journey to clean my house. Every time I started protesting like a little girl, ‘Do you ever stop?’ she would say something like ‘That’s none of your business. I have a lot of work to do, Missy!’ So I keep cleaning with her.”

After the woman in the gray dress finished cleaning house, Lauren envisioned an obese cartoon character, who seemed like a mother, dancing in a G-string bikini. “She starts shaking her ass and thighs and arms and titts and she laughs. So joyful and happy. And there is so much beauty in it,” Lauren says. “I am almost dying in laughter. I am just having fun with that woman who loves her body which is breaking all standards of what I think I am supposed to look like. It felt like two hours of laughter.”
“It is time for you to retire your extra, extra small life!”

But then at a certain point, Lauren sits up and the grandma in the gray dress is back. “She tells me, ‘It is time for you to retire your extra, extra small life!’ I see clothes coming out of my closet that are double zero. And I am trying to purge, but I don’t know if I can do it,” she describes. "It wasn’t just about the xxs size clothes," she says, "but about the 'mental restrictions' I had imposed upon myself."

“I was really trying to get on board with what I knew to be true, but it was so hard, so hard for me to get behind this,”
Lauren remembers. “I was wailing and grieving that extra, extra small life and my pride of being tiny and thinner than other people. All that bullshit that plagued and shrank me. I managed to crawl over to the fire and I was still bargaining with her: Can I maybe keep my scale? But she was like, ‘No. You are not getting a back door. Yes or no? What do you want? If I let you keep it, your life is not going to change!’”

“Eating disorders don’t discriminate,”
Lafrance explains. “They can happen to anyone and any family type. So it is really hard to pinpoint what is causing them.” They are complex and often a collision of factors and events in a person who is either neurobiologically more vulnerable or has experienced significant challenges and trauma in their life. “But there seems to be one important shared factor across eating disorders that has been shown in a number of different studies,” says Lafrance, “and that is a difficulty with processing emotions.”

These can manifest differently, she says. “Patients struggling with anorexia nervosa, for example, might have a hard time even naming emotions, never mind attending to them, labeling them, or regulating them.” So in a way eating disorders might just be a dysfunctional coping mechanism of sorts. “Starving can numb distress,” Lafrance says. “Binge eating can soothe, and purging can provide relief.”

Identifying the importance of emotional processing vis-à-vis eating disorders is huge, she adds, since classic psychedelics are well positioned for just that: To help patients target and transform their ability to process emotions. Psychedelics, says Lafrance, hold the potential to reduce fears when approaching painful memories and emotions—so while tripping, it becomes easier to tolerate emotionally upsetting topics and to address them in a healthy manner, while otherwise the person might feel disoriented, dissociate, or experience ego loss when approaching the same topic or memory.
“There seems to be one important shared factor across eating disorders that has been shown in a number of different studies, and that is a difficulty with processing emotions.”

In another qualitative study whose results have not yet been published, Lafrance and colleagues interviewed various ceremony facilitators about eating disorders and ayahuasca. “One common characteristic that was either observed or perceived in the context of eating disorders by the ceremony leaders was that of a spiritual void,” says Lafrance. “They felt that eating disorders signified that an individual was struggling with lack of self-love, lack of self-worth and a lack of spiritual connection.“ Several also mentioned similarities among eating disorder patients, and those who struggle with addiction.

Those interviewed—either indigenous facilitators themselves, or trained in an indigenous shamanic tradition—felt that the conventional treatment programs had too narrow a focus on behaviors and symptoms, Lafrance reports. They felt that emotional and spiritual deficiencies and aspects of healing were not emphasized enough.

“I strongly believe that we need to combine the wisdom from these indigenous practices with a focus on behavioral symptoms because it’s the behavioral symptoms that end up being lethal,” says Lafrance, who adds that she would like to include the benefits of both worlds into future eating disorder treatments: spiritual healing, as well as behavior therapy in an approach combining indigenous wisdom and clinical methodology.

Lafrance is now involved in not less than three clinical trials in Canada, the US, and in the UK that are about to start or have just recently begun with psilocybin, ketamine and MDMA.

She collaborates as clinical supervisor in a pilot study looking into Psilocybin as a treatment for anorexia nervosa at Imperial College in London. She will look into the potential of MDMA for anorexia nervosa and binge eating disorder in a MAPS sponsored study happening simultaneously in Denver, Toronto and Vancouver that just received FDA and ethics approval. And she will be looking at anorexia nervosa and emotion-focused ketamine-assisted psychotherapy in collaboration with Novamind, a private company sponsoring psychedelic research as well as facilitating psychedelic retreats in Costa Rica and the Netherlands. In all three study set ups, a caregiver or a loved one will be recruited together with the patient. “Eating disorders don’t only affect individuals,” she says. “They affect families in significant ways.”

Furthermore, John Hopkins University as well as the Eating Disorder Treatment and Research Center at University of California in San Diego are about to start their first clinical trials for psilocybin and anorexia nervosa.

All five studies will assess safety, feasibility and preliminary outcomes first. “We’re at the very beginning of this work. So we really need to show that it’s safe,” Lafrance explains, noting that scientists need to be sure that these psychedelic substances will be well tolerated by the patients.

Lauren knew deep down that retiring her extra, extra small life was the reason she came to ceremony, yet still she felt resistance. “But all of a sudden, I see naked men and women and children and I am focusing on those naked female bodies and the different sizes and shapes,” she recalls. “I am Jewish. And in that context I realize that I am looking at a concentration camp with these people being incarcerated. Mama Ayahuasca in her gray dress looks at me and says, ‘You spit in their face hating your body! Stop it!'” Still sobbing, Lauren managed to spin around. “Time and space disappear and all of a sudden I am looking at the stars. I see the same people that I saw in the camp and I see my ancestors and my mom and my sister and my dad and I know one day we will all be there. And finally I am in the space of discomfort that’s necessary for the shift to happen—and I can let go of my patterns and my dysfunctional behavior.”

Indeed, Lauren’s entire family struggles with eating: Her mother, she says, has trauma and used food to numb, while her father was concerned with weight, as if it were a “moral value.” Needless to say, Lauren adds, her eating disorder developed at an early age. “When I was a little girl I had this idea that I had a very ugly face, a face that nobody would ever love,” she says. “I think that some of what has happened in my family felt ugly and I took it on and wore it. So I decided that if I didn’t have a perfect body nobody would ever love me because my face felt deformed.”
“One of my goals is to bring more love into psychotherapy.”

When Lauren, who now is a therapist herself, looks back on her experience she says she was “locked out” of her own heart—as is much of the population, she surmises. “In the end it is a homecoming journey. All progress is return. It’s like an archeological dig into your authentic self. And I am incredibly proud of myself how far I came on this path.”

Lafrance’s perspective towards her future work points toward a similar direction. “One of my goals is to bring more love into psychotherapy,” she says. It’s a term that has been some sort of a taboo in the therapeutic context in the past—and maybe that’s exactly why the field of mental health, itself, could use some of the perspective offered by psychedelics.

“When I think about individuals with eating disorders, I see a real difficulty both in feeling other people’s love as well as expressing love freely to others,” says Lafrance. “The psychedelic renaissance is pointing us in a direction of being able to talk about love openly and directly, to support our patients to heal their relationship with love.”

 
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Could psychedelics tackle the obesity crisis?*

by Jason Mast | ENDPOINTS NEWS | 17 Sep 2019

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

A study in mice funded by Eleusis and published in Scientific Reports found a long-known drug called (R)-DOI could be used to treat cardiovascular disease, reducing inflammation in the aorta, decreasing overall and HDL cholesterol levels, and potentially curbing diabetes by increasing glucose tolerance.

Lead author Charles Nichols says diabetes and high cholesterol, though often results of the same underlying condition, require separate drugs and a restricted diet.

“This model that treats cardiovascular disease and metabolic disease — it’s all-encompassing,” Nichols, a professor of pharmacology at LSU, told Endpoints News. “Translated into the clinic in humans, it would be as if someone was obese, had diabetes, had high cholesterol, and was able to take a low dose of this drug at a sub-behavioral level and really treat several different aspects of the complications of being obese.”

They’re bold words, though almost muted in a psychedelic field brimming with hype. Researchers have called the results of some psychiatric studies “mind-blowing” as clinical trials hint at the power of psilocybin (the chemical in magic mushrooms) to alleviate depression and MDMA to relieve PTSD.

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David Nichols

The notion that the same class of drugs might have other physiological and specifically anti-inflammatory effects is newer. Nichols, the son of longtime psychedelic research proponent David Nichols, understands the rhetoric can get rosy but points out that the trial was targeted. They tested DOI in other types of tissue and when it had little effect, focused on vascular indications.

“This is not a complete panacea,” said Nichols, who earlier touted his animal studies indicating DOI’s potential in asthma.

Nichols discovered that serotonin 5-HT2A receptor agonists, following a well-understood pathway psychedelics act on, can reduce inflammation by accident in his LSU lab in 2008. Later, he got a cold call from Shlomi Raz, a former Wall Street executive who went on to get a master’s in psychology at NYU.

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Shlomi Raz

Eleusis launched in 2013 with a mission, Raz told Endpoints, of exploring the broad possibilities for these agonists, with their work so far ranging from a trial on the effects of ‘micro-dosing’ LSD on time perception to filing a patent for the treatment of Alzheimer’s with LSD. Nichols has published several previous studies on psychedelics and anti-inflammatories, but this was notable in its ability to onramp into clinical trials.

Raz believes what is commonly called psychedelics have a broad array of impacts beyond their “psychedelic” function. He says he has peer-reviewed research coming soon that will help bolster that claim, and that the central question is how to unlock those effects without triggering the psychological impact.

“If you think of it as an iceberg,” Raz said, “maybe the tip of the iceberg is the psychiatrics and the part below the surface is not psychiatric.”

The vascular study showed physiological without any psychological effects (mice given a psychedelic can sometimes show behavior consistent with psychosis). The researchers fattened up mice on the “Western diet” for four months and at intervals administered DOI to one group and saline to a control.

They found that vascular inflammation was lower in the DOI, as they anticipated. They hadn’t anticipated that cholesterol would be down and glucose tolerance up, and they’re still not sure why.

Nichols, though, said the study was translatable to a clinical trial, and he was hopeful there would be a drug within 10 to 20 years. Regulation, more than the science, was the barrier. Raz was mum about what’s next, both in terms of other applications and in business model, but he left one clue:

“I can tell you it’s not a pill,” he said, “at first.”

*From the article here :
 
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Albert Hofmann

World-first trial investigating psilocybin psychotherapy for anorexia

by Rich Haridy | Aug 27 2019

Scientists from the Johns Hopkins Psychedelic Research Unit are commencing a landmark human clinical trial to explore the effects of psilocybin in persons with chronic anorexia nervosa (AN). The new trial adds to a growing body of evidence finding psychedelic psychotherapy effective for depression, addiction and obsessive-compulsive disorder.

Last year the FDA granted Breakthrough Therapy status to psilocybin-assisted psychotherapy for severe treatment-resistant depression. The designation was a quiet but extraordinary step forward in legitimizing the field of psychedelic science, particularly following a similar designation granted to MDMA treatment for PTSD.

Psilocybin is the primary psychoactive compound found in what are commonly referred to as magic mushrooms. In the human body the compound is rapidly converted in psilocin, which subsequently generates the drug’s mind-altering effects.

The team at the Johns Hopkins Psychedelic Research Unit has been at the forefront of the modern psychedelic science renaissance, exploring the effects, and potential medical uses, of a number of psychoactive compounds including LSD, DMT and MDMA. But, the team has primarily been leading a lot of work into the clinical possibilities of psilocybin, from exploring the drug’s potential as a smoking cessation aid, to its uses in helping treat depression and anxiety, particularly in patients suffering from life-threatening cancer.

The latest therapeutic target for the psychedelic science researchers is severe eating disorders. In an email to New Atlas, Natalie Gukasyan, a post-doctoral research fellow at Johns Hopkins, explains the goal of this novel human trial.

“This open-label study will test the effects of two moderate to high doses of psilocybin given in combination with motivational interviewing-based psychotherapy,” says Gukasyan. “Our goal is to determine whether psilocybin can be safely administered in a supportive setting to people with anorexia nervosa (AN), and whether this intervention can produce improvements in mood, quality of life, and cognitive and behavioral symptoms of the disorder.”

Gukasyan believes there are several reasons why eating disorders, and AN in particular, are strong targets for psilocybin treatment research. With the highest mortality rates of any psychiatric disorder, it is fair to say AN is difficult to effectively treat, and in need of new therapeutic strategies. Based on prior work from the Johns Hopkins team, Gukasyan suggests the meaningful experiences produced by psilocybin therapy should effectively translate to those with AN.

“We seek to determine if psilocybin can have similar effects in those suffering with AN,” explains Gukasyan. “The pathophysiology of AN remains obscure but some evidence suggests that the serotonin 2A (5-HT2A) receptor system may be involved. The action of psilocin, the active metabolite of psilocybin, is mediated by stimulation of these receptors. AN also shares phenomenological parallels to anxiety and addiction, both of which have been shown to improve with psilocybin-assisted interventions.”

The research is not without a small volume of interesting precedents. A compelling 2017 study investigated the therapeutic value of ayahuasca, a traditional Amazonian psychedelic brew, in helping individuals with eating disorders. The study was obviously not a rigorous clinical trial, but instead an investigation into the experiences of 16 subjects with previously diagnosed eating disorders who embarked upon ceremonial ayahuasca consumption.

A number of anecdotal reports have also suggested substances such as LSD and MDMA can be beneficial for eating disorders. MDMA in particular may be well suited to treating eating disorders considering its proven success with PTSD, and while some researchers are working on getting trials underway, there are suggestions it may not be the right drug for this condition. As Timothy Brewerton, a professor of psychiatry at the Medical University of South Carolina, told Vice in 2018, "some individuals suffering from eating disorders can use MDMA to specifically help them not eat.”

Gukasyan suggests her team’s focus on psilocybin is more related to their experience and expertise using this particular psychoactive compound. The new trial also will be working closely with the experienced clinicians from the Johns Hopkins Eating Disorders Program.

“…our team has a strong track record of safely administering psilocybin in hundreds of volunteers, making it a natural choice for our study drug,” Gukasyan tells New Atlas. “MDMA has a different mechanism of action and risk profile; others in the field are developing protocols to investigate its safety and utility in the treatment of eating disorders.”

The research team is only at the earliest recruitment stage of the trial and is currently looking for participants. This phase 1 trial will be modest, but is expected to take between two and three years, primarily due to the challenges in finding appropriate subjects to participate.

Gukasyan says those interested in the research can explore details of the trial and potential participants can find an online screening form at www.hopkinspsychedelic.org.

“If our intervention is effective the next steps would be to further clarify the mechanism by which it works, perhaps with brain imaging or other neurocognitive measures,” says Gukasyan on the future of the research. “Phase 2 and 3 studies with larger sample sizes and placebo-controlled conditions would be necessary to further establish this as a viable treatment for AN.”

 
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Field Trip’s Toronto location

Multi-site study of MDMA-assisted therapy to treat eating disorders*

Psylocybin alpha | 7 Jan 2021

Field Trip Health Ltd., a leader in the development and delivery of psychedelic therapies, is pleased to announce it has, subject to completion of a final site inspection, been selected as a trial location for a MAPS-sponsored study on the safety, feasibility and preliminary outcomes of MDMA-assisted therapy to treat eating disorders (the “Eating Disorder Study”), including Anorexia Nervosa.

The MAPS-sponsored multi-site study will be the first of its kind assessing the viability of MDMA-assisted therapy to treat eating disorders, including Anorexia Nervosa and Binge Eating Disorder.

Anorexia Nervosa is a mental health condition and eating disorder characterized by low weight, food restriction, fear of gaining weight and a strong desire to be thin. Anorexia is also the most deadly mental illness, with a higher mortality (death) rate than any other mental illness, leading to potential cardiac complications, heart, kidney and liver failure, bone loss, anemia and suicide.

Subject to the site inspection, Field Trip’s Toronto location will be used as the trial site for the Health Canada-approved Anorexia Nervosa arm of the Eating Disorder Study. Field Trip’s Canadian Medical Director, Dr. Michael Verbora, will act as the Qualified Investigator and Site Physician for this site. During the Anorexia arm of the Study, Field Trip will be hosting MAPS-trained therapists who will be providing MDMA-assisted therapy to an initial cohort of individuals suffering from Anorexia Nervosa, and collecting safety, feasibility and preliminary outcome data.

In December, MAPS announced partial results of its first Phase 3 randomized, double-blind, placebo-controlled study assessing the safety and efficacy of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD). According to MAPS, the study generated statistically significant results demonstrating that MDMA-assisted therapy may be an effective treatment for PTSD resulting from various types of trauma, including trauma occurring in childhood and in patients with dissociative subtype of PTSD, pending assessment by the U.S. Food and Drug Administration (FDA). Further, no unexpected or serious safety signals emerged during the course of the trial.

*From the article here :
 
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Psychedelic-assisted psychotherapy for weight loss

Newsfile Corp. | 3 June 2020

The Yield Growth Corp. announces that its majority owned subsidiary NeonMind, filed a U.S. provisional patent application in the United States for the invention relating to therapeutic administration of psilocybin combined with supportive therapeutic treatment for a patient to provide weight loss benefits and treatment for related health issues.

The provisional patent is for a proposed guided psychedelic psilocybin therapy protocol using psychotherapy prior to, during and after the psychoactive effects of the Psilocybin are felt by the patient. The psychedelic assisted psychotherapy is designed to assist in gaining insights from positive psychedelic experiences, to be integrated into everyday life and to help plan, prepare and make sense of psychedelic experiences for a therapeutic result. It can include an exploration of unresolved issues in the patient's life that are embedded in his or her subconscious, including discussions or examinations of pain. It may also include building self-esteem, the patient taking responsibility for his or her own condition, self empowerment, and acknowledging or releasing any unhealthy self defence mechanism of overeating.

NeonMind previously announced that it filed a provisional patent in December 2019 for the use of microdose administration of Psilocybin for weight loss benefits. NeonMind has retained contract research organization Translational Life Sciences Inc. to design and plan an initial preclinical study using psilocybin which is anticipated to begin in the fall of 2020. The preclinical study is anticipated to provide data to design phase 2 human clinical trials to test Psilocybin as a weight loss treatment. The phase 2 clinical trials are anticipated to begin in 2021, subject to receiving all required regulatory approvals.

NeonMind's combined provisional patent applications cover the administration of Psilocybin to provide weight loss benefits and potential treatment or regulation of diabetes, and regulation of blood glucose, and to reduce susceptibility to cardiovascular disease, high blood pressure, diabetes mellitus, hypertension, multiple sclerosis, erectile dysfunction, urinary incontinence, chronic renal failure, sleep apnea, asthma, and certain forms of cancer.

The U.S. provisional patent application provides a right of priority under the Paris Convention as well as the Patent Cooperation Treaty ("PCT"). This means it establishes an effective filing date for inventions adequately described within it for PCT applications or applications in more than 170 countries who are members of the Paris Convention, as long as the foreign application is filed within one year of the provisional filing date.

 
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Psilocybin therapy could help with obesity

Baystreet Staff | 11 Mar 2021

The world is in desperate need for new treatments for major issues, such as mental health and obesity. That’s where companies, such as NeonMind Biosciences, Cybin Inc., Tryp Therapeutics Inc., Mind Medicine Inc., and Compass Pathways can come into play and hopefully assist millions of people in need.

The obesity epidemic for example, is bursting at the seams. According to the World Health Organization (WHO) obesity has tripled in size over the last 50 years. In 2016, they note, 1.9 billion adults were overweight around the world. Of those, 650 million were considered obese. Just in the U.S., nearly 34% of adults and up to 20% of children are obese. By 2030, almost half of U.S. adults will be considered obese. By 2030, almost half of U.S. adults will be obese.

That’s where a company like NeonMind Biosciences could help

At the moment, the company is exploring psilocybin as a potential treatment for obesity and to support weight loss. In fact, NeonMind’s first drug candidate employs psilocybin as an agonist to the serotonin receptor 5-HT2A, which is involved in the hallucinogenic effect of psychedelics. The second drug candidate employs psilocybin as an agonist to the serotonin 5-HT2C receptor, which controls appetite.

In addition, NeonMind Biosciences just announced that on March 10, 2021, NeonMind engaged Certara®, the global leader in model-informed drug development to provide strategic integrated drug development support for the investigation of NeonMind’s psilocybin based drug candidates for the treatment of obesity.

NeonMind is exploring psilocybin as an innovative treatment approach to support weight loss. NeonMind’s first drug candidate aims to use synthetic psilocybin to enhance a patient’s ability to alter behaviours that cause weight loss through psychedelic-assisted cognitive therapy. The second drug candidate proposes low dose synthetic psilocybin as a treatment to suppress appetite.

“Certara has the expertise, technology and network to further our drug development efforts to help us achieve our goals of progressing psilocybin-based weight loss treatments through the rigorous drug development process,” said Rob Tessarolo, President & CEO of NeonMind. “We are assembling world-class R&D capabilities dedicated to creating a dossier of scientific evidence to support regulatory approval for these novel treatments that can positively impact millions of people.”

The typical roadmap to regulatory submission for a product involves a sponsor like NeonMind to complete a complex interconnected sequence of evaluations on the product’s quality (CMC – chemistry, manufacture, and controls), preclinical efficacy, safety pharmacology and toxicology, and preclinical and clinical pharmacological characterization.

The evaluations and their sequence are established in an integrated drug development plan by a cross-functional team of experts.

Pursuant to the engagement, NeonMind with access to global leaders in drug development strategy, due diligence, toxicology, clinical pharmacology, regulatory science, and the full spectra of drug development subject matter experts across Certara.

Certara provides biosimulation software to transform traditional biopharmaceutical R&D with a scientific team that has more than 3,500 years of collective drug discovery and development experience. Since 2014, 90% of new drug and biologic approvals by the US FDA have been received by Certara’s customers.

 
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World-first trial investigating psilocybin psychotherapy for anorexia*

by Rich Haridy | New Atlas | 27 Aug 2019

Scientists from the Johns Hopkins Psychedelic Research Unit are commencing a landmark human clinical trial to explore the effects of psilocybin in persons with chronic anorexia nervosa (AN). The new trial adds to a growing body of evidence finding psychedelic psychotherapy effective for depression, addiction and obsessive-compulsive disorder.

Last year the FDA granted Breakthrough Therapy status to psilocybin-assisted psychotherapy for severe treatment-resistant depression. The designation was a quiet but extraordinary step forward in legitimizing the field of psychedelic science, particularly following a similar designation granted to MDMA treatment for PTSD.

Psilocybin is the primary psychoactive compound found in what are commonly referred to as magic mushrooms. In the human body the compound is rapidly converted in psilocin, which subsequently generates the drug’s mind-altering effects.

The team at the Johns Hopkins Psychedelic Research Unit has been at the forefront of the modern psychedelic science renaissance, exploring the effects, and potential medical uses, of a number of psychoactive compounds including LSD, DMT and MDMA. But, the team has primarily been leading a lot of work into the clinical possibilities of psilocybin, from exploring the drug’s potential as a smoking cessation aid, to its uses in helping treat depression and anxiety, particularly in patients suffering from life-threatening cancer.

The latest therapeutic target for the psychedelic science researchers is severe eating disorders. In an email to New Atlas, Natalie Gukasyan, a post-doctoral research fellow at Johns Hopkins, explains the goal of this novel human trial.

“This open-label study will test the effects of two moderate to high doses of psilocybin given in combination with motivational interviewing-based psychotherapy,” says Gukasyan. “Our goal is to determine whether psilocybin can be safely administered in a supportive setting to people with anorexia nervosa (AN), and whether this intervention can produce improvements in mood, quality of life, and cognitive and behavioral symptoms of the disorder.”

Gukasyan believes there are several reasons why eating disorders, and AN in particular, are strong targets for psilocybin treatment research. With the highest mortality rates of any psychiatric disorder, it is fair to say AN is difficult to effectively treat, and in need of new therapeutic strategies. Based on prior work from the Johns Hopkins team, Gukasyan suggests the meaningful experiences produced by psilocybin therapy should effectively translate to those with AN.

“We seek to determine if psilocybin can have similar effects in those suffering with AN,” explains Gukasyan. “The pathophysiology of AN remains obscure but some evidence suggests that the serotonin 2A (5-HT2A) receptor system may be involved. The action of psilocin, the active metabolite of psilocybin, is mediated by stimulation of these receptors. AN also shares phenomenological parallels to anxiety and addiction, both of which have been shown to improve with psilocybin-assisted interventions.”

The research is not without a small volume of interesting precedents. A compelling 2017 study investigated the therapeutic value of ayahuasca, a traditional Amazonian psychedelic brew, in helping individuals with eating disorders. The study was obviously not a rigorous clinical trial, but instead an investigation into the experiences of 16 subjects with previously diagnosed eating disorders who embarked upon ceremonial ayahuasca consumption.

A number of anecdotal reports have also suggested substances such as LSD and MDMA can be beneficial for eating disorders. MDMA in particular may be well suited to treating eating disorders considering its proven success with PTSD, and while some researchers are working on getting trials underway, there are suggestions it may not be the right drug for this condition. As Timothy Brewerton, a professor of psychiatry at the Medical University of South Carolina, told Vice in 2018, some individuals suffering from eating disorders can use MDMA to “specifically help them not eat”.

Gukasyan suggests her team’s focus on psilocybin is more related to their experience and expertise using this particular psychoactive compound. The new trial also will be working closely with the experienced clinicians from the Johns Hopkins Eating Disorders Program.

“…our team has a strong track record of safely administering psilocybin in hundreds of volunteers, making it a natural choice for our study drug,” Gukasyan tells New Atlas. “MDMA has a different mechanism of action and risk profile; others in the field are developing protocols to investigate its safety and utility in the treatment of eating disorders.”

The research team is only at the earliest recruitment stage of the trial and is currently looking for participants. This phase 1 trial will be modest, but is expected to take between two and three years, primarily due to the challenges in finding appropriate subjects to participate.

Gukasyan says those interested in the research can explore details of the trial and potential participants can find an online screening form at www.hopkinspsychedelic.org.

“If our intervention is effective the next steps would be to further clarify the mechanism by which it works, perhaps with brain imaging or other neurocognitive measures,” says Gukasyan on the future of the research. “Phase 2 and 3 studies with larger sample sizes and placebo-controlled conditions would be necessary to further establish this as a viable treatment for AN.”

*From the article here :
 
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Dr. Reid Robison

Ketamine a game changer in treating eating disorders

by Liz Braun | Toronto Sun | 29 May 2021

Eating disorders are difficult to treat.

They are among the most deadly mental health conditions, second only to opioid overdose.

An estimated 5% to 20% of patients with anorexia nervosa, for example, will die from complications of the disease.

About 25% of those with anorexia nervosa, bulimia or binge eating attempt suicide.

There are virtually no FDA approved drugs to treat anorexia, but there is finally hope on the horizon through psychedelics.

Ketamine, MDMA and psilocybin are proving useful with treatment-resistant mental illnesses, including eating disorders.

Dr. Reid Robison is a psychiatrist and Chief Medical Officer of Novamind, a Toronto-based mental health company focused on psychedelic research and treatments. Novamind offers ketamine-assisted psychotherapy; the company announced three weeks ago that it is doubling its clinic numbers from four to eight, anticipating a 225% increase in client visits this year.

“The bottom line here is what psychedelic medicine does to enhance neuroplasticity,” said Robison in a recent interview.

“It opens a window of opportunity for therapeutic work, giving the mind a break from tightly held, long held patterns. Psychedelics turn down the default network, and enhance the ability to now consciously choose thoughts and actions.”

The window lasts for days afterward, he added, extending the opportunity to do therapeutic work.

Robison has seen psychedelics help countless individuals.

He and his colleagues are always trying to find more treatment options.

“And then about 10 years ago, along came ketamine. It’s been around for years as an anesthetic, of course, but this was for for treatment-resistant depression. I was sitting with people before, during and after treatment and I was blown away by what I saw. It’s not just a treatment for depression."

“There are so many other benefits.”

In the last few years, research in psychedelics has expanded to include psilocybin, MDMA, ayahuasca — what Robison calls classic psychedelics. He’s been working with the nonprofit MAPS on an upcoming study into MDMA-assisted psychotherapy as a treatment for eating disorders.

"It’s time for action on eating disorders," said Robison.

"Anorexia has a high mortality rate. We need a sense of urgency. With cancer, nobody ever tells a patient, ‘Let’s wait until it’s a stage three or four before we intervene,’ but with eating disorders, between the stigma and the reluctance of insurance companies, we do see that. ‘We can’t admit you, you’re not sick enough yet to receive intensive treatment.’

“That’s not OK! This illness is underfunded and under recognized. It needs more research, more treatment options, more advocacy.”


Canada, he said, has been leading the way in the study and use of these potential medications.

“I believe we have some promising tools coming down the pike. Psilocybin and MDMA are only in research studies, so we’re working mostly with ketamine combined with psychotherapy and having very positive results.”

Initially, he said, there was a bit of stigma attached to these therapies.

“People called me 10 years ago and asked, ‘How can you use ketamine in psychiatric work?’ And I wanted to say, ‘How can you not be using it when so many are suffering?’ Especially with this impressive efficacy."

“It’s our obligation to look for new and improved modalities.”


 
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How psychedelics treat eating disorders

by Brian Lissak | PSYTECH | 2 Feb 2021

Nearly 30 million Americans suffer from an eating disorder, resulting in 10,200 deaths annually. Perhaps more than other mental illnesses, eating disorders demonstrate the interconnectedness of our mental and physical well-being. An eating disorder is a severe disturbance in one’s eating habits due to psycho-emotional distress. Potentially life-threatening conditions can result if untreated. However, there are no widely effective treatments. Psychiatric medications have proven ineffective, and talk therapy is only slightly better.

What are eating disorders?

An eating disorder is a serious disturbance in one’s eating behaviors. Though it’s not clearly understood how, this disturbance is linked to emotional and psychological states. In the vast majority of cases, eating disorders are concurrent with a host of other psychiatric disorders. These include anxiety, depression, obsessive compulsive disorder, alcohol and drug abuse, and others. Untreated, eating disorders can lead to a variety of health issues. There are many types of eating disorders. We’ll detail two of the most common.

Anorexia Nervosa

Anorexia nervosa is characterized by limited food intake, fear of being “fat,” and body image issues. Sufferers often exercise compulsively and take laxatives or force themselves to vomit in order to lose weight. No matter how thin the person becomes, they still see themselves as fat. Over enough time, the body becomes malnourished and goes into starvation. This can result in menstrual period cessation, anemia, muscle atrophy (including heart muscle), hypotension, severe constipation, lethargy, osteoporosis, and osteopenia (thinning of the bones). That’s just to name a few of the physical symptoms. The mental symptoms, which are both a cause and a result of anorexia nervosa, include obsessive-compulsive behavior, severe anxiety, and bouts of depression.

Binge Eating Disorder

Binge eating disorder is when people have frequent episodes of consuming large quantities of food over a short period of time. People who struggle with binge eating feel out of control during these episodes. Unlike those with anorexia nervosa, they do not purge the food by inducing vomiting or taking laxatives. Binge eating disorder is chronic and can lead to severe health complications including cardiovascular disease, hypertension, obesity, and diabetes. Those who binge eat will often feel disgusted with themselves, or guilty and ashamed of their behavior. These feelings lead to emotional repression, depression, anxiety, and a tendency to hide the behavior from others.

How psychedelic-assisted psychotherapy can treat eating disorders

Eating disorders are some of the most complicated and life-threatening mental health illnesses. Obviously, the first goal in treating someone with an eating disorder is getting them physically healthy. This includes treating malnutrition, obesity, diabetes, hyper/hypotension, and so on. However, unless the emotional and psychological sides are treated, the harmful eating behavior will return.

The power of psychedelic-assisted psychotherapy is that it gets to the root cause. It lowers ego defenses and temporarily dismantles habituated neural pathways. This allows one to freely explore their identity and safely interact with traumatic memories. Eating disorders have proven so difficult to treat because they present with a host of other mental illnesses. However, it is becoming increasingly clear that these other mental illnesses are symptoms of an underlying problem. It is hoped, and with good reason, that psychedelic-assisted psychotherapy can cut through all of the complicated layers associated with eating disorders and help the person heal at their very core.

Psilocybin-assisted psychotherapy for treating Anorexia

Researchers at UC San Diego are conducting early phase trials testing the safety and feasibility of psilocybin-assisted psychotherapy for those suffering from anorexia. The study’s primary goal is to assess safety, as this population has never received psilocybin-assisted psychotherapy before. The study’s secondary goal is to assess the efficacy of psilocybin-assisted psychotherapy on anorexia. Based on recent clinical trials in other mental illnesses, there is strong reason to believe it is both safe and effective.

Participants will receive preparatory and integrative psychotherapy sessions, and one session with a single 25mg dose of psilocybin. The study began in December 2020, and will run until the end of this year.

MDMA-assisted psychotherapy for treating eating disorders

MAPS is currently conducting a Phase 2 trial on the safety and feasibility of MDMA-assisted psychotherapy for anorexia nervosa and binge eating disorder. This study is doing something quite novel in the world of psychotherapy. Every participant who suffers from an eating disorder has a supportive caregiver as a treatment ally. This could be a parent, sibling, partner, or friend. The supportive caregiver receives non-drug therapy to aid them in supporting the trial participant. The inclusion of a treatment ally reflects the evolving view of medicine, which is increasingly looking at psycho-social components in both illness and health. The supportive caregiver also reflects the unique nature of eating disorders, which so clearly link physical and mental health.

Since MDMA-assisted psychotherapy has proven safe and effective in treating other mental health issues like anxiety, PTSD, and depression, it is hoped it can treat eating disorders as well.

Ayahuasca ceremonies and reduction in eating disorder symptoms

Psychologist Adele Lafrance has been doing research on eating disorders and participation in ayahuasca ceremonies. Ayahuasca is a psychoactive plant blend from the Amazon basin. Indigenous groups have used it in healing ceremonies for generations. In the last half-century, ayahuasca has seen rising popularity among westerners who are exploring its benefits as well. With the scientific community’s renewed interest in psychedelic-assisted psychotherapy, ayahuasca has received special attention.

Lafrance’s research shows that ayahuasca ceremony participation significantly reduced eating disorder symptoms and body image perception while improving overall mental health. This research further bolsters the growing consensus that psychoactive compounds can have a positive impact on many branches of psychotherapy. For those suffering from an eating disorder, psychedelic-assisted psychotherapy may offer hope where other treatments have failed.

 
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Psychedelic therapy for eating disorders*

Experts see a "mechanistic grounding" for testing psychedelics on EDs.

by Taschauna A. Richards, MS, RMHCI | Psychedelic Science Review | 25 Jun 2021

The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) defines feeding and eating disorders (ED) as “a persistent disturbance of eating or eating-related behavior that results in the altered consumption or absorption of food and that significantly impairs physical health or psychosocial functioning.”

Approximately 30 million Americans suffer from eating disorders, and the rate drastically rises to 70 million people around the world suffering from eating disorders at any given time, most often women between the ages of 12 and 35 EDs are difficult mental disorders to treat due to the lack of consistent evidence suggesting one treatment over another, and due to the high dropout rates of patients in treatment and exceptionally high relapse rates. Research suggests that over 50% of those who proceed with treatment for EDs continue to struggle with symptoms and remain chronically ill. This inconsistency in the treatment for EDs calls for more stability for promising treatments and therapeutic modalities that transcends across differential demographics and characteristics.

In many cases, eating disorders co-occur with other psychiatric disorders such as anxiety and panic disorders, obsessive-compulsive disorders, and substance use disorders. Without treatment that addresses both the emotional and physical symptoms of these disorders, malnutrition, heart problems and other potentially fatal conditions can result.

A recent resurgence in research into psychedelic compounds such as LSD, MDMA, psilocybin, and ayahuasca show the potential to be utilized as therapeutic tools in the field of mental illness for treating conditions including mood, affective and substance use disorders, and as of most recently, EDs. Recent studies provide evidence that psychedelic treatment can have profound effects to help those recover from their eating disorder symptoms by uncovering and resolving the root causes for related contributing factors.

Current treatments for eating disorders

Cognitive Behavioral Therapy (CBT), a psychotherapeutic treatment often combined with pharmacological treatment, is an example of a treatment that may only be efficacious in the management of co-morbid conditions or for weight recovery in EDs. These symptom-focused treatments often overlook the more fundamental components that underlie EDs. There is a growing interest in the therapeutic use of classic psychedelic compounds including LSD, psilocybin (the major psychedelic component in magic mushrooms), and DMT (dimethyltryptamine), the major psychedelic component of ayahuasca – substances that “exert their key behavioural effects via serotonin type 2A (5-HT2A) receptor agonism.”

The impact of psychedelics on eating disorders

Recent clinical trials have shown a potential mediating role that psychedelic therapy can develop from psychedelic experiences.
"As abnormal serotonin functioning and high emotional avoidance are hypothesised to play a role in EDs, there is a mechanistic grounding for exploring the use of psychedelics in the treatment of EDs.”

Psychedelic treatments allow for a safe avenue to confront challenging emotions and the ability for revision of core beliefs and behaviors. Such processes can result in revising problematic, long-held mental schemata and behaviors, particularly pertinent in EDs, where emotional and experiential avoidance is high. Emotional breakthrough may be an additional mechanism through which psychedelic-assisted psychotherapy may be relevant for the treatment of EDs. Results from psychedelic treatment studies for EDs revealed improvements in depression and wellbeing scores two weeks after a psychedelic experience, yielding to immense emotional release and great personal insight which promotes positive mental health changes.

Conclusion

The therapeutic use of classic psychedelic compounds including LSD, psilocybin, and DMT show promise for the treatment of comorbid conditions for recovery in people combating eating disorders. When combined with specialized psychotherapy, psychedelic medicine shows potential for a novel therapeutic approach to treat eating disorders. Psychedelic treatment can aid in the treatment of eating disorder symptomology by going deeper than traditional treatments have in the past to uncover and resolve the underlying compounding concerns.

*From the article here :
 
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Did you know Psychedelic Therapy can help treat Eating Disorders?

by Karla Illicic | Healing Maps | 9 Jun 2021

Psychedelics and psychedelic therapy mostly associated with mental health issues such as anxiety, depression, and PTSD. But did you know both can potentially help treat eating disorders, too?

With new research, there’s incredible potential of psychedelic substances for other types of treatment methods. Addiction and eating disorders are conditions that many struggle with. Having psychedelic therapy as an option could make all the difference.

Eating Disorders 101

Eating disorders are serious illnesses associated with severe disturbances in eating behaviors, thoughts and emotions. They disrupt the relationship between food, body image, weight, and even exercise. This can severely impact one’s physical and mental health.

The most common eating disorders include anorexia nervosa, bulimia nervosa, and binge-eating disorder, all of which have descriptions below.

Anorexia Nervosa

Anorexia Nervosa is a severe and sometimes fatal eating disorder. It leads to abnormally low weight, fear of food, and gaining weight. It also skews the perception of body image.

Those suffering from anorexia believe they’re overweight and live in fear of gaining weight if they consume food. Therefore, they often combine excessive exercise in an attempt to lose weight. They often avoid and restrict foods, and try to control their calorie intake. This may lead to vomiting after eating (crossover with bulimia), or by misusing laxatives, diet aids, diuretics or enemas.

Over time, the loss of nutrients can lead to malnutrition and severe health complications. These include negative effects on the heart, the inability to concentrate, memory issues, abdominal discomfort and pain, loss of period and irregular hormone levels, weakened bones and osteoporosis, among other issues.

Current treatments exist to stabilize weight loss and begin to restore and maintain adequate weight and nutrition. The hope is to restore a process of normalcy, and to develop long-term behavioral changes.

They mostly include some form of psychotherapy, as well as medications, mostly antipsychotics and SSRIs (antidepressants). Unfortunately, these options don’t work for everyone, and more people are searching for alternative methods to help long-term.

Bulimia Nervosa

Bulimia nervosa is similar to anorexia. It involves the fear of gaining weight and brings a distorted perception of one’s body shape and size. However, this involves eating large quantities of food, then vomiting in an attempt to lose ingested calories.

It can lead up to the same health complications as anorexia, but it can also have a severe impact on the digestive tract and gut lining. Current treatments once again include psychotherapy, antidepressants and antipsychotics, which more people find unsuccessful.

Binge-Eating Disorder

A binge-eating disorder usually involves eating large amounts of food to the point of severe overeating, followed by strict restriction. These cycles keep on repeating and causing an impaired relationship with food. It also impacts one’s perception of their own health and weight.

Unlike anorexia and bulimia — where the result usually ends in weight loss and really low BMI — those suffering from a binge-eating disorder may develop other complications. These include obesity, diabetes, and other gastro-intestinal, hormonal, or heart conditions. Current treatments include psychotherapy, mostly cognitive-behavioral therapy (CBT), and antidepressants or antipsychotics.

Psychedelic Therapy and Eating Disorders

Current treatment options from the most common eating disorders are all the same. That’s where psychedelic therapy comes in as an alternative.

The habitual pathways of communication between brain regions appear to be overactive in certain mental health conditions. These are often depression, anxiety, OCD and eating disorders. This is the brain’s default mode network (DMN). This connection may lead to the impairment of cognitive flexibility, which psychedelic therapy has shown to treat with great results.

The current, ongoing research shows impressive results from: Ketamine, MDMA, Psilocybin and Ayahuasca.

Ketamine as Psychedelic Therapy

In 1998, the first ketamine-assisted trial occurred, with infusions given to a group of 15 women suffering from extreme cases of anorexia nervosa. Nine of them eventually fell into remission. More than 20 years later, researchers are now aware of how this type of psychedelic therapy can block compounds like glutamate and inhibit NMDA receptors. Both of these fuel anorexic thoughts and behaviors.

MDMA as Psychedelic Therapy

Currently, there are Phase 2 trials to discover if MDMA helps treat anorexia and other eating disorders. Researchers believe the psychedelic may aid in both recovery and potential remission. More info is necessary, but, at present, those conducting trials are optimistic about the outcome.

Psilocybin as Psychedelic Therapy

This form of psychedelic therapy is being studied as more than just an aid in treating depression, anxiety and PTSD. They are now on a path to help treat eating disorders as well and help those who really can’t seem to see any results from medications.

By increasing dopamine and serotonin to the brain, psilocybin may be one of the best non-invasive ways to pair psychedelics with psychotherapy. The studies will show for themselves.

Ayahuasca as Psychedelic Therapy

Ayahuasca is also one of the psychedelics currently going through research as a potential alternative treatment for eating disorders. Participants often feel more distant from their behaviors, thought patterns and triggers. They also tend to notice a shift in attitude toward their bodies. It may be too early to draw conclusions, but these preliminary results only fuel optimism for further research.

Utilizing psychedelic therapy for eating disorders has shown early, positive results. However, more studies are necessary to determine if psychedelics are safe and an effective option.

 



Psilocybin treatment may support patients with obesity who have tried everything

Pharmacy Times | 19 Jul 2020

Clive Ward Able, MD, BPharm, president of Clintell, consultant to NeonMind Inc, and a trained pharmacist and physician, discusses his research into the use of psychedelic compounds to treat obesity.

Pharmacy Times
interviewed Clive Ward Able, MD, BPharm, president of Clintell, consultant to NeonMind Inc, and a trained pharmacist and physician, on his research into the use of psychedelic compounds to treat obesity and optimize human health.

Ward Able noted that the use of psychedelic medicine to treat obesity has 2 potential mechanisms of approach. The first is by giving a psychedelic compound as part of psychotherapy, such as psilocybin, at a psychedelic dose—this approach is called drug-enhanced psychotherapy. At this dose, it works as an agonist against serotonergic receptors, and, specifically, the 5-HT2A receptors.

“What that does is it gives you the psychedelic event, which seems to be able to help along with psychotherapy,” Ward Able said. “Secondly, it also has effects on the 5-HT2C receptors, which are very much related to satiety or hunger and the control of hunger. So there, we can look at a different formulation where we use a much lower dose, probably 10% to 15% of what would normally be used for a psychedelic dose, but you do that on a daily or 4 times a week dosing.”

This lower dose may potentially lead to an increase in satiety, causing a patient to be less hungry, according to Ward Able. Additionally, it has the potential to give the patient a sense of well-being.

However, to date, there's been no clinical research done on the effects of psychedelic medicine on obesity, but there have been promising in-vitro pre-clinical studies on rats. In these pre-clinical trials, the rats were fed a highly palatable, high calorie diet in which they could eat as much as they liked. They were then treated with 2 different doses of psilocybin—a high dose that would be equivalent to a human psychedelic dose—and a lower dose that would target the 5-HT2C receptors.

“What was found with those is that both the high dose and the low dose led to less weight gain in both of those arms that were treated with the psilocybin,” Ward Able said. “The decrease in the weight gain gives us a very good, strong signal that this actually is working the way we expect it to work. Now we've got to translate this into clinical studies, and that's what we're going to be doing next in our proof of concept study.”

Ward Able explained that before he began working on research in the psychedelic medicine field, he had thought it was a very contained, small group of researchers working in the field.

“But actually, there's a lot of work that's been going on, and we have to tip a hat to a lot of researchers who worked under a really strict regulatory environment, and still managed to continue some of this research, despite it being completely closed down in the 60s and 70s,” Able said. “One of the things that NeonMind Inc. looked at was obesity, because it's a pandemic now, not just an epidemic within the North American region, but a pandemic worldwide.”

The health implications of the global pandemic of obesity are significant, not only for the patient, but for every health care system and the country as a whole, Clive Ward Able explained.

However, he noted that not every patient who is obese is dissatisfied with their weight or finds that it poses a problem in their life. In light of this, a potential psychedelic medicine treatment for obesity would provide an option for patients who are interested in losing weight and keeping it off, something that they have not been effectively able to do in the past.

“The idea is that this has to come from the patient. If the patient wants help for it, this will be able to help them get to a place where they really want to be,” Ward Able said. “I'm not talking about every single obese patient, because there are a lot of obese patients who are happy the way they are, and they don't necessarily want to lose weight. But there's a large component of those, such as in depressed patients, who have certain triggers that get them to overeat or not to exercise, etc.

Ward Able noted that the target of obesity treatment is not necessarily to bring every patient under a body mass index of 25. Instead, this treatment can hopefully allow patients to get to a healthier weight and maintain it, with an added sense of wellbeing that they may desire after losing weight.

“This is where I think psychedelics can add to what is being done now,” Ward Able said. “Psychotherapies are being used for the treatment of obesity or weight management, but people tend to fall back into their old behaviors again, although they do work. What I'm calling drug enhanced psychotherapy or psilocybin-assisted psychotherapy adds another facet to that psychotherapy, which should be able to instill much longer lasting positive behaviors, such as an improved diet, whether that's quantity or quality, or within expenditure of energy, such as increasing your amount of exercise.”

 
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LSD Cured My Eating Disorder

by Adeline Fox | Psymposia

As a teenager, I was taking ten milligrams of Ritalin daily. Later, I grew to love the way these pills made it easier for me not to eat.

While a great deal has been written about the potential for psychedelic drugs to aid in the treatment of mental illnesses, I have found one condition conspicuously absent from this discussion.

Long story short: LSD cured my eating disorder. As a nineteen-year-old college student, I took six-hundred micrograms alone in my dorm room. The next morning I woke up a completely different person and I haven’t skipped a meal since.

We ought to look closely at the impact psychedelics have on self-esteem and body image. At most, what I can do is share my story in the hopes that it will spark discussion. While I am not a neuroscientist, I know that the frontal lobe of the brain, an area responsible for the evaluation of consequences, does not fully develop until an individual’s mid to late twenties. This sheds light on some aspects of my story.

As a teenager, I was taking ten milligrams of Ritalin daily. I was prescribed Ritalin as a treatment for Attention Deficit Hyperactivity Disorder (ADHD), and I took it even though I did not believe I had ADHD. I was diagnosed at the age of seven and medicated by the age of ten. By high school, I began to doubt the accuracy of my diagnosis. Unfortunately, by then I had grown an appreciation for the way that stimulants helped me study.

Later, I grew to love the way these pills made it easier for me not to eat.

As a senior in high school I had come to the conclusion that my appearance was the most important thing about me and that I had better do everything within my power to improve it. But I didn’t want my friends to see me skip lunch in the cafeteria or my parents notice me avoiding the dinner table.

In college, no one was paying any attention to whether or not I ate. Life became a struggle against one of the most basic human drives: hunger.https://www.psymposia.com/subscribe

I knew that my thoughts and behaviors did not make logical sense, but it was LSD that shed new light on the problem, allowing me to stop what I was doing before it got worse.

One Friday night like any other, I decided to trip. I tried to follow the advice of a more experienced friend of mine. He said it was best to have no expectations going into a psychedelic experience. If you have no expectations, you can’t be disappointed.

I put three, two-hundred microgram tabs on my tongue, set up my yoga mat in the center of my room, and attempted to clear my mind. I was hoping to be changed in some way, but had no specific goals. I recalled a line from Timothy Leary’s treatise, The Psychedelic Experience. It is parenthetical in the context of the piece, but I’ve always considered it a key point, and a powerful argument: “…at the very worst,” he wrote, “you will end up the same person who entered the experience.”

Lucky for me, that’s not what happened.

I spent most of the following twelve hours in bed, thinking. It didn’t take long to figure out that this was going to be a rough night.

I tried distracting myself with music. A few seconds into the first song, however, multi-colored patterns of light suddenly came spiraling towards me out of my window fan. I felt a painful sensation course through me. I was overstimulated. I turned the music and lights off, closed my blinds, and got back into bed.

I was acutely aware of my foot twitching, my armpits sweating, my heart rate increasing. I felt as if I could see my body even with my eyes closed. My body appeared to me, through closed-eye hallucinations, like an Alex Grey painting – all my veins bright blue. I felt my blood pumping through me. I couldn’t calm myself down. It was extremely unpleasant.

Soon, my body began to feel as if it had no outline, no boundary. I got up and paced around in an attempt to preserve the boundary between myself and the world. Everything felt connected but rather than experiencing this as blissful, as many people do, I panicked.

I was on the brink of the ecstatic ego death I had read so much about, but it was simply terrifying.

I opened my window and let the cold, February air blow at me. The goosebumped sensations on my arms assured me that I existed. I stretched on my yoga mat in a further attempt to connect to my body rather than lose track of it completely. Then, I thought of something my yoga instructor said at the beginning of each class: “Be kind to yourself and approach each pose with gentle curiosity.”

I decided that this guidance would get me through the long, hard night. If I managed to be kind to myself, if I approached this experience with gentle curiosity rather than fear, nothing bad would happen.

Later, I had a very different series of thoughts. It occurred to me that I had eaten nothing all day. The next thought came as a reflex, a pattern I had been practicing for years: Good, I thought. You’re losing weight.

I had agreed to be kind to myself, but I couldn’t last even a few hours before I broke this promise. I made a more specific, more difficult promise instead: I was going to change. I was going to stop hurting myself.

The next day, I was conscious of my thoughts in a way I had never been before. I measured each thought against the promise to be kind to myself, and found that I had no choice but to change my thoughts in order to change my behaviors.

The really amazing fact of the matter is, this was easy. It was not the long journey that therapy might have been. Twelve hours was all it took for me to turn my life around, with no outside guidance and no plan.

This transformation in outlook also cascaded into a series of healthy improvements. Over the next few years I quit smoking cigarettes, quit taking Ritalin, and stopped taking dangerous drugs at parties. Some credit here may have to be given to my developing frontal lobe, but LSD was the catalyst that sparked these changes.

Again, I hope this story leads to further discussion of the potential for psychedelics in the treatment of eating disorders. For individuals who may be interested in the healing power of the psychedelic experience, the only pieces of advice I can give are the gems of wisdom I was lucky enough to receive, which guided my transformation:

Free yourself of expectations. Be kind to yourself. Approach with gentle curiosity. And above all else, remember, in the worst case scenario, you will wake up tomorrow the same person you are today.

 
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