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Paper 24 October 2024: Expert recommendations for Germany’s integration of psychedelic-assisted therapy

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Psychedelic-assisted therapy (PAT) is a modality of mental health treatment that merges psychotherapeutic interventions with psychedelic states, often facilitated by substances such as lysergic acid diethylamide (LSD), psilocybin, and 3,4-Methylenedioxy-methamphetamine (MDMA). The latter two being in phase III trials. Whereas MDMA is considered an entactogen that enhances self-awareness and emotional connectivity, psilocybin is a naturally occurring psychedelic compound found in certain mushrooms. Recent research suggests that these and other psychedelics, all small molecules, most with benzene or phenyl rings, uniquely work by reopening a “critical period” in the brain, allowing for new learning within social contexts in a process involving changes in brain plasticity and oxytocin signaling [1]. Despite their classification as a Schedule I drugs under the Controlled Substances Act by the Drug Enforcement Agency (DEA) in the United States, their therapeutic potential has been increasingly recognized, with demands from the public to make them available for those with treatment resistant conditions. These among other developments resulted in MDMA being granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of treatment-resistant PTSD (TR-PTSD) in phase II, (phase III studies were for ‘moderate to severe’ PTSD). Psilocybin (COMP360) and a deuterated psilocybin analogue (CYB003) were granted FDA Breakthrough Therapy designation for treatment resistant depression (TRD) [2,3,4].

Methodologically rigorous clinical research suggests that PAT may offer substantial long-term alleviation of symptoms in patients suffering from psychopathologies such as PTSD, TRD, major depressive disorder (MDD), end of life anxiety, obsessive–compulsive disorder (OCD), substance use disorders (SUD), psychotic conditions, and more [56]. Notably, a single session of substance-assisted therapy has been reported to lead to significant symptom reduction, with some patients achieving remission that can persist for at least twelve months [7]. This enduring effect underscores the potential of psychedelic-assisted therapy in providing therapeutic outcomes that are significantly superior to antidepressant medications such as SSRIs, which often have poor efficacy rates and unwanted side-effects such as agitation, weight gain, sexual performance difficulties, gastrointestinal issues, and other symptoms [18].

In February 2024, Lykos (formerly MAPS PBC) submitted a new drug application (NDA) to the FDA for MDMA (Midomafetamine) capsules in combination with psychotherapy for the treatment of PTSD [9]. Following the submission, a citizen petition was filed, raising concerns about the integrity of the clinical trials. This prompted the FDA to convene an advisory board meeting in June 2024 to review the claims. The petition raised several issues, including alleged bias in the trial design, inadequate sample diversity, insufficient double-blinding, underreporting of adverse events such as sexual misconduct, and confusion regarding the integration of psychotherapy within the study design [10]. Despite the principal view that MDMA trials are sound, and even the FDA’s participation in the creation and oversight of the studies these concerns influenced the FDA’s review process. Subsequently, in August 2024, the FDA issued a final decision rejecting the NDA under the Prescription Drug User Fee Act (PDUFA). It is important to note however that the FDA encouraged ongoing MDMA research and asked for another Phase III trial.

This decision led to additional actions, including the Journal of Psychopharmacology retracting three articles related to the MDMA clinical trials conducted by the MAPS research team and the initiation of an FDA investigation. Lykos has since filed for a reevaluation of their NDA. If approved, MDMA would become the first psychedelic-assisted therapy officially recognized in the United States.

As unexpected as the August 2024 rejection of the application by Lykos for approval of MDMA was for some, the hope based on the phase II studies, remains that either MDMA or psilocybin will within the next two to three years receive a positive evaluation from the FDA although the exact timing remains unknown. Unlike the MDMA trials, where the FDA was initially satisfied with the blinding process prior to the advisory board meeting, Compass’ psilocybin trials were designed to minimize the unblinding caused by psychotropic effects, following the FDA’s advice to their satisfaction until this day.

Lykos and Compass have been the two major companies driving development, and although Lykos has yet to submit a new phase III proposal, Compass continues with their phase III clinical trial. In general enthusiasm in the field for further research continues as there remains a need for novel treatments, and despite the uncertainty, the FDA seems generally favorable toward psychedelic medicine [10].

This paper outlines the current and required infrastructure for the successful integration of PAT, including rescheduling of psychedelic drugs beyond ketamine, accessibility, reimbursement strategies, accreditation of practitioners, ethical considerations and educational requirements. The role of the German government and affiliated agencies is pivotal in shaping this framework, ensuring that the setup not only complies with regulatory standards but also supports the ethical deployment of these therapies.

Moreover, with the European Medicines Agency (EMA) currently deliberating on the integration of psychedelics within the European framework, Germany has a unique opportunity to lead by example, showcasing a meticulous approach to the adoption of psychedelic-assisted therapies and must therefore also prepare to accommodate these innovative treatments [11]. This could serve as a model for other European nations, promoting a harmonized approach to these promising treatments across the continent.

The first half of this paper covers the regulatory environment in Germany, as it is impossible to understand the steps required to make PAT a reality without some in-depth understanding of the country’s unique health care system. The second half of this paper covers the German provision of outpatient mental healthcare and how and where PAT would fit and critically, proposes a training scheme for the education of PAT facilitators.

Historical roots of psychedelics in Germany

Psychedelic research in Germany harkens back to the 1910s and 1920s when the atypical psychedelic MDMA was first synthesized, and pioneering research was being conducted on the properties of mescaline. During this early period, Beringer and colleagues [12] saw in mescaline and similar substances, an opportunity to explore the phenomenology of psychopathology, creating what they described as ‘model psychoses.’ Although problematic in many ways, this stream of research opened up a new dimension of empathy and understanding into the experience of individuals with chronic psychosis [13]. In fact, the research carried out at the University of Heidelberg, culminating in Beringer’s habilitation thesis “Der Meskalinrausch” from 1927, can be considered the first major work in the field of psychedelic psychopharmacology in the West [12]. Another noteworthy event in the history of psychedelic drugs in German-speaking Europe is Albert Hoffman’s accidental discovery of the properties of lysergic acid diethylamide (LSD) on April 19, 1943, which accelerated interest in psychedelic compounds throughout the Western world [14]. In particular, this landmark event led to the widespread experimental use of psychedelics for a diverse range of psychiatric conditions across Europe and North America.

This period of research during the 1950s and 1960s, though short-lived, would later become known as the first wave of psychedelic research [1415]. During this brief moment in history, Betty Eisner, a German-educated American, first described the implementation of low-dose LSD in combination with psychotherapy, making a major contribution in the field which still today remains underrecognized [16]. Margot Cutner, a German psychoanalyst who was leading psychedelic research in England after fleeing from the Nazis, provided some of the first insights on the relevance of the role of the facilitator in psychedelic-assisted therapy (PAT) and the now well-known notion of ‘set and setting’ [16]. Following this, Hanscarl Leuner coined the term “psycholytic therapy” at the University of Göttingen underscoring the drug’s therapeutic potential in a sub-threshold dose range [17]. Despite Leuner and colleagues’ extensive research on LSD being among the most comprehensive bodies of work on the topic to date, it has been largely neglected until recently due to never being published in English [18].

A surprising turn of events occurred when in 1961, the United States passed the seemingly politically motivated US Controlled Substances Act, which resulted in an immediate and indefinite suspension of psychedelic research throughout the U.S. Europe was quick to follow suit, and psychedelics became labeled as potentially dangerous and addictive with no accepted medical use [19]. Subsequently, despite early breakthroughs and extensive research, these restrictions ushered in a prohibition era that would last decades, hampering progress and limiting the exploration of psychedelic compounds throughout the Western world. Germany was no exception, and psychedelic treatments now being championed for their therapeutic potential were outlawed.

Economic burden of treating PTSD and depression in Germany

The economic and human costs of PTSD and depression in Germany highlight an urgent need for more effective interventions [20]. Trauma-related healthcare costs range from 524.5 million to 3.3 billion euros annually [21], while depression adds another 1 to 5.2 billion euros [2223]. Current pharmaceutical treatments, such as serotonin-reuptake inhibitors (SSRI), offer limited efficacy and fail to fully address the needs of individuals with PTSD, depression, or their comorbidities [24].

A recent study of German insurance claims highlighted both the direct and indirect costs of PTSD (ICD-10-GM F43.1) [2021]. PTSD patients typically suffer for about 6 years, with a 50–100% likelihood of comorbid conditions such as major depressive disorder (MDD), panic disorder, and substance use disorder (SUD). Per-patient costs were 43,000 EUR, three times higher than for those without PTSD, driven by increased healthcare utilization, impaired work capacity and reduced quality of life. PTSD also accounts for approximately 200,000 Disability-Adjusted Life Years (DALYs) annually in Germany, a metric that reflects both premature mortality and years lived with disability, quantifying the overall burden of disease [25].

Similarly, depression carries significant economic burdens with indirect costs from labor absenteeism, social benefits, and prevention measures estimated at 10 to 16 billion euros annually, surpassing direct healthcare costs [2627]. Depression accounts for approximately 470,000 DALYs in Germany [28], while globally, PTSD contributes an additional 3 million DALYs, underscoring its substantial public health impact.

In short, PTSD and depression remain conditions with a high unmet need. SSRIs, first introduced in 1988 (fluoxetine), are still the primary pharmaceutical treatment for many psychological disorders, despite their limited efficacy and adverse side effects, including symptom exacerbation and suicidal thoughts [29].

Regulatory landscape

The European Medicines Agency (EMA) grants marketing authorization for new medicines across the EU. The sponsor of the medication submits an application for approval to the EMA following phase III trials, and after EMA approval, marketing authorization is granted, which allows the medication to be sold in all European Union member states. Sponsors then must decide which member states they wish to enter, as, even if the Sponsor has marketing authorization, each EU state has its own rules about how health insurers will be reimbursed for new medications. European member states furthermore have country specific processes and infrastructure around the provision of therapeutic services which are an essential part of PAT.

In Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees both clinical trial approval (pre- and post-EMA approval) and the documentation as well as considerations related to safety, efficacy, and quality, and specific labeling requirements tailored to the German context (Fig. 1).

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https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-06141-3?utm_medium=email&_hsmi=97789529&utm_content=97789529&utm_source=hs_email



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Psychedelics

Jacobin Article: “Nationalize Psychedelics” | Cannabis Law Report

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Here’s the introduction

here were high hopes that MDMA-assisted therapy would be approved by US regulators in 2024. The data showed that the drug-therapy combo significantly reduces post-traumatic stress disorder (PTSD) symptoms, or even eases them completely — despite a strong placebo effect in the trials, which involved well under a thousand participants. When the study data was published in September 2023, the New York Times reported that MDMA-assisted therapy was “inching closer to approval.” But in an August ruling that came as a wake-up call to figures in the nascent psychedelic industry as well as an underlying psychedelic movement made up of a hodgepodge of campaigners, the Food and Drug Administration (FDA) declined to give the green light, citing a lack of convincing clinical evidence and issues with the studies. The FDA requested further data from a new study, which would take several years, marking a significant setback for the prospect of medical psychedelics.

As early as 2026, however, the FDA will likely have another opportunity to approve another psychedelic drug for Americans with depression — psilocybin, which is derived from magic mushrooms — depending on the results of late-stage research. Even if it does pass, the therapy will likely not be immediately covered by insurance and so will remain beyond the reach of most Americans. This reality, plus the fact that psychedelics are meant to make you feel more interconnected (and thus perhaps less likely to want to squeeze profits from your peers), raises an intriguing possibility: that the psychedelics industry could be nationalized for the public good.

“Psychedelics, like pharmaceutical products, are just going to be inaccessible to many, many people,” says Professor Susi Geiger, a patent expert from University College Dublin. Step one to ensuring equitable access, and giving hospitals some respite from the straightjacket that often forces them to pay well over the odds for drugs, is reforming a patent system that enables Big Pharma to hike prices on existing drugs cartel-style thanks to the monopolies they enjoy over their products. To prevent the far-out possibility of Google founder Sergey Brin controlling the price of certain psychedelic therapy protocols, Geiger suggests a complete moratorium on private patents over psychedelics. “That’s the equivalent of nationalizing it at the source and keeping it as a public good.”

The idea may sound utopian and raise more questions than it immediately solves, even if the US patent office got on board and Congress created a European-style semi-socialized health care system, free at the point of use. “How can we trust exclusive access through a national health service when the state has only previously handled access [to psychedelics] through prohibition and religious censorship?” asks Chris Byrnes, a patent attorney at CalyxLaw. Matt Brockmeier, counsel at Antithesis Law, says less charitably: “I don’t trust the federal government — this or any other administration — to oversee something as monumental as our collective consciousness. Their track record is abysmal; they ruin everything they so much as look at because of the influence of special interests, fraud, waste, abuse, outright corruption, and general incompetence.”

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https://jacobin.com/2024/10/psychedelics-nationalization-psilocybin-mdma-therapy



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Canada -Chocolate bricks filled with magic mushrooms seized at Peace Bridge warehouse

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Members of U.S. Customs and Border Protection said they are continuing to investigate after several shipments of chocolate bricks filled with magic mushrooms were found at the Peace Bridge warehouse at the Port of Buffalo, New York.

In a news release, U.S. CBP said officers discovered “multiple commercial shipments” containing psilocybin, the chemical compound found in magic mushrooms, at the warehouse over the past 30 days.

The shipments were coming from Canada to the U.S.

“CBP officers working in the Peace Bridge cargo facility discovered multiple shipments manifested as ‘chocolate and other food preparations,’” the news release read.

“Upon further inspection of these shipments, it was discovered that the chocolate bricks contained psilocybin, a schedule 1 controlled substance.”

The chocolate bricks were “field tested” by officers and the substances tested positive for the “properties of psilocybin.”

According to the release, there were a total of 15 seizures with a weight of about 10 kilograms in the last 30 days.

The estimated street value of the drugs, officers said, is believed to be US$165,000.

https://www.cp24.com/news/canada/2024/10/11/chocolate-bricks-filled-with-magic-mushrooms-seized-at-peace-bridge-warehouse/



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Most Of Mental Health Professionals Want Psychedelic Theraphy

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Psychedelics are experiencing a resurgence in the field of mental health care. Once relegated to the fringes of both medical practice and legality, compounds such as psilocybin, MDMA, LSD, and ketamine are now being re-examined for their therapeutic potential. A recent survey reveals that a significant portion of mental health professionals are open to incorporating psychedelic-assisted therapy into their practices—on the condition that these treatments are legalized and regulated. This shift in attitude reflects both growing scientific evidence for psychedelics’ efficacy and increasing awareness of their ability to address treatment-resistant conditions like depression, anxiety, and PTSD.

Psychedelic Therapy: A Re-Emerging Field

In recent years, research on psychedelics has surged, leading to promising results in the treatment of mental health conditions that often prove resistant to conventional therapies. The Multidisciplinary Association for Psychedelic Studies (MAPS) and other research institutions have been conducting clinical trials on substances like MDMA for PTSD, psilocybin for depression, and ketamine for treatment-resistant depression and suicidal ideation. These studies demonstrate that psychedelic substances, when combined with psychotherapy, offer rapid and sustained relief from symptoms with minimal side effects when administered in controlled environments.

A survey conducted among mental health professionals, including psychiatrists, psychologists, counselors, and social workers, has provided valuable insight into their perspectives on psychedelic therapies. While many respondents expressed enthusiasm about the potential of psychedelics, the key barriers identified were the current legal status and regulatory uncertainty surrounding these substances.

Survey Results: Mental Health Professionals Support Psychedelics Under Regulation

The survey revealed that 69% of respondents were willing to use or recommend psychedelic-assisted therapy for their patients if it became legal in their jurisdiction. Mental health professionals are particularly interested in the use of psychedelics for treatment-resistant conditions, such as major depressive disorder (MDD) and PTSD, where traditional treatments have often been insufficient.

Despite this enthusiasm, concerns remain about the need for proper regulation and oversight. Professionals emphasized that legal frameworks would need to ensure that psychedelic therapies are delivered safely and effectively, with clear guidelines for dosing, set and setting, and professional training. There is also a push for psychedelic therapists to receive specialized education, much like those working in other areas of pharmacological therapy.

Legal and Ethical Considerations

Currently, most psychedelics remain classified as Schedule I substances in the United States under the Controlled Substances Act, meaning they are considered to have no accepted medical use and a high potential for abuse. This legal status poses a significant barrier to their use in clinical settings, despite mounting evidence to the contrary.

In regions where decriminalization or medical use of psychedelics has gained momentum, such as Oregon and Colorado, psychedelic therapy is slowly becoming more accepted. Oregon, for instance, was the first state to legalize the supervised therapeutic use of psilocybin in 2020. Meanwhile, several cities, including Denver and Oakland, have decriminalized the possession of psilocybin and other entheogenic plants. These local efforts highlight a growing recognition that psychedelics, when used responsibly and within the right context, can provide healing opportunities for individuals who have exhausted traditional treatment methods.

However, mental health professionals have raised concerns about the ethical implications of widespread psychedelic use. They stress the need for stringent training requirements for therapists, particularly because psychedelic experiences can induce profound and sometimes overwhelming emotional responses. In therapeutic contexts, these experiences need to be properly integrated into a patient’s broader psychological framework, requiring both expertise and ethical responsibility.

Majority of Mental Health Professionals Support Psychedelic Therapy If Legal
Majority of Mental Health Professionals Support Psychedelic Therapy If Legal

Scientific Evidence Behind Psychedelic Therapies

The growing interest in psychedelic-assisted therapy is not simply a matter of changing societal attitudes—scientific research increasingly supports its efficacy. Some of the most promising results come from studies on psilocybin and MDMA.

  1. Psilocybin and Depression: Psilocybin, the active compound in magic mushrooms, has shown significant potential in treating depression, including treatment-resistant depression. A study published in JAMA Psychiatry demonstrated that two doses of psilocybin, combined with supportive psychotherapy, reduced depressive symptoms in patients for up to a year. Many participants reported a profound sense of emotional clarity and connectedness, which allowed them to process deeply ingrained feelings of sadness and despair.
  2. MDMA for PTSD: One of the most well-known psychedelic therapies is MDMA-assisted therapy for PTSD. Clinical trials led by MAPS have shown that MDMA, when administered in a therapeutic setting, helps patients with PTSD by lowering the emotional intensity of traumatic memories, making it easier for them to process these experiences. In Phase 3 trials, over 60% of participants no longer met the diagnostic criteria for PTSD after just three sessions of MDMA-assisted therapy.
  3. Ketamine: Already approved for clinical use as esketamine, ketamine has gained attention for its rapid-acting antidepressant effects. When used in low doses under medical supervision, ketamine can rapidly alleviate symptoms of treatment-resistant depression and suicidal ideation, providing relief within hours or days, compared to the weeks or months it takes for traditional antidepressants to take effect.

Training and Certification: A Key Concern

One of the most consistent points raised in the survey is the importance of ensuring that mental health professionals are adequately trained to administer psychedelic therapies. Given the profound psychological effects that psychedelics can induce, therapists need specialized training in both the administration of these substances and the integration of the experiences that arise during therapy sessions.

Many professionals also argue for the creation of certification programs that would establish clear standards for psychedelic therapy. These certifications would ideally cover:

  • Dosing protocols
  • Managing difficult or overwhelming experiences (often called “bad trips”)
  • Psychological preparation and integration techniques
  • Safety measures for vulnerable populations, such as those with a history of psychosis or bipolar disorder

Without proper training, the risks of psychedelic therapy, including re-traumatization or psychological destabilization, could outweigh the benefits, particularly in cases of complex trauma or severe mental health disorders.

The Future of Psychedelic-Assisted Therapy

As the legal and regulatory landscape around psychedelics continues to evolve, it is clear that the mental health field is preparing for the potential widespread adoption of psychedelic therapies. The survey’s findings indicate that the majority of mental health professionals are open to the integration of psychedelics, particularly if legal barriers are removed and appropriate safety measures are put in place.

The future of psychedelic therapy will likely involve a blend of clinical trials, regulatory changes, and public education about both the risks and benefits of these treatments. Mental health professionals will play a critical role in shaping how these therapies are implemented, ensuring that they are used ethically and effectively in clinical settings.

If legalized, psychedelics could mark a paradigm shift in mental health care, offering new hope for individuals suffering from anxiety, depression, PTSD, and other psychiatric conditions that have proven difficult to treat with conventional methods.

Conclusion

The survey of mental health professionals provides a glimpse into the future of psychedelic-assisted therapy. The openness of clinicians to these treatments, contingent upon legalization, suggests a broader acceptance of psychedelics as viable therapeutic tools. As research continues to support the safety and efficacy of psychedelics for treating mental health disorders, the field is poised for significant changes. The next few years may see these once-controversial substances become part of mainstream psychiatric treatment, revolutionizing how conditions like PTSD, depression, and anxiety are managed.

Sources

  1. Sermo Barometer Survey: 94% of Global Mental Health Professionals Open to Psychedelic Treatments. Business Wire, 2024.
  2. Moliner, R. et al., “Psychedelic treatments are speeding towards approval,” Nature, 2023.
  3. How Psychedelic Treatment Can Revolutionise Mental Health. Health Europa, 2024.
  4. Lewis, C. R. et al., “MDMA and PTSD: Clinical Applications,” Frontiers in Psychiatry, 2023. DOI: ​(Nature).
  5. The Survey



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