Medical research into using the psychedelic MDMA to treat post-traumatic stress disorder is being called into question following allegations that a clinical trial investigating the treatment was potentially tainted by misconduct. 

The U.S. Food and Drug Administration is currently conducting a review of the psychedelic commonly called ecstasy for patients with PTSD. The treatment is being developed by the Multidisciplinary Association for Psychedelic Studies (MAPS) and its public benefit Lykos, which has conducted clinical trials in a bid to have the therapy approved by the FDA. In 2017, the FDA designated the MDMA-assisted treatment for PTSD as a breakthrough therapy, indicating it may be a significant improvement over existing therapies and clearing the way for further research.

The clinical trials tested MDMA in conjunction with intense therapy administered by a pair of therapists to a group of patients with PTSD. In one stage of the trial, 94 patients were given either MDMA or a placebo during three therapy sessions spaced one month apart. Participants also completed integration sessions to help them process their experiences during the drug therapy sessions.

At the end of the trial, 71% of participants in the MDMA group had experienced an improvement in symptoms and no longer met the diagnostic criteria for PTSD. Among the placebo group, 48% of participants had similar results. Some participants in both groups experienced adverse effects such as anxiety or heart palpitations, although none of the adverse effects were characterized as serious.

“Consistent with PTSD, suicidal ideation was observed in both groups,” the authors reported in the journal Nature Medicine, “MDMA did not appear to increase this risk, and no suicidal behavior was observed.”

Group Reveals Concerns About the Validity of Research Findings

While the research results are promising, an independent investigation of the clinical trial has determined that the findings may not tell the whole story. In a recent draft report, the Institute for Clinical and Economic Review (ICER), a nonprofit that evaluates clinical trials and drug prices, said the investigation found “substantial concerns about the validity of the results” of the MDMA clinical trials. Following the report’s release, a citizen petition filed with the FDA alleged that possible misconduct and ethical violations could mar the credibility of the MDMA research.

The ICER report acknowledges that the research data shows that MDMA may be an “important addition to treatment options for PTSD.” But it also listed several factors that could cloud the results of the study.

The report notes that it is not easy to conduct research into psychedelics because it is difficult to obscure which participants are receiving a placebo and which are receiving the active drug because of the unmistakable effects of psychoactive drugs. As a result, most of the study subjects correctly guessed which group they were in, according to a review of the research released by the FDA on Friday. Without proper blinding, the findings can be skewed by participants or researchers, many of whom see strong promise in the therapeutic potential of the compounds.

“There’s the possibility that the data might not be representative of what’s actually happened in clinical trials,” Neşe Devenot, one of the authors of the citizen petition and a senior lecturer in the writing program at Johns Hopkins University who is involved in psychedelic research, told NPR. “I don’t think this has been publicly reckoned with.”

Additionally, the report notes that “very strong prior beliefs” among therapists, researchers and patients influenced the results of the trial.

“Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients including discouraging reports of substantial harms, potentially biasing the recording of benefits and harms,” the report states.

The research was also marred by allegations from a study participant that two therapists– a married couple– engaged in inappropriate physical contact while the subject was under the influence of MDMA during a treatment session in Canada. An investigation by MAPS determined that the couple had “substantially deviated” from the treatment protocol, leading the organization to notify health authorities in Canada and the United States. Additionally, the therapists were barred from administering MDMA-assisted therapy in affiliation with MAPS.

The ICER report has not been finalized, but Dr. David Rind, the chief medical officer for the group says its investigation showed that “there’s still a lot of uncertainty” about using MDMA to treat PTSD.

“You have a group of people who are very upset about how these trials went,” he said. “We couldn’t tell, even though we talked with people where this happened, whether that represents a tiny fraction of bad events or a number of bad events large enough to have rendered the trial just not believable.”

Investigators involved in the research, however, have rejected claims that the study is flawed. Jennifer Mitchell, lead author of the published papers from the Phase 3 trials, says she stands behind the study’s findings.

“I didn’t feel any pressure from the sponsor to come up with anything different than what the data was providing,” said Mitchell, a professor of neurology and psychiatry at the University of California, San Francisco and associate chief of staff for research at the San Francisco VA Medical Center. “I wouldn’t have continued to work with them if I had felt that.”

The FDA review also expressed concerns about the safety of MDMA, including the risk of abuse and possible side effects that could harm the cardiovascular system and the liver. Lykos CEO Amy Emerson said the company stands by the quality and integrity of its research and development process. 

“Given there has not been a new PTSD medication approved in the United States in over two decades for the 13 million people living with PTSD, we are deeply committed to making a difference by bringing a potential new treatment to patients,” she said in a statement cited by the Washington Post.

Shawn Hauser, a partner at the cannabis and psychedelics law firm Vicente LLP, said it is not surprising that the FDA’s consideration of new MDMA-assisted therapies is raising questions, noting that the use of a psychedelic drug in conjunction with therapy is uncharted territory for the agency. The FDA drug evaluation process is difficult to apply to certain substances and treatments including psychedelics and other compounds including botanical cannabis, although for different reasons.

“The promising research makes clear the potential of this therapy for treating PTSD, and while there are certainly challenges in these studies (as with any study) and legitimate concerns that must be addressed, these must be considered in the broader context of the severe unmet treatment needs by patients with PTSD and the strong data on safety and efficacy,” Hauser wrote in an email to High Times. “The questions around this process clearly underscore that the FDA evaluation process requires modernization to appropriately evaluate treatments like MDMA-assisted therapy and substances like botanical and natural medicines.”

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A pilot program on the benefits of synthetic psilocybin for mental health issues like post-traumatic stress disorder (PTSD) is set to begin this summer at Yale University in New Haven, Connecticut. 

A study cohort will consist of 50 patients, mostly veterans and first responders, who are with mental health concerns like depression and addiction. Participants will take 25 mg of synthetic psilocybin, and after the psychedelic effects wind down, they will discuss issues and progress (or lack thereof) with trained therapists.

Connecticut Post reports that the goal is to fulfill the need for state data that has been lacking, according to state Rep. Michelle Cook (D-Torrington).

“We need to have the data to show that there is documented proof of what that therapy does,” Cook said. “We know that it has some incredible outcomes when it is done right, when it’s done by people that are trained in how to use it for treatment of PTSD and so forth.”

Researchers at Yale have been studying the “psychological, neurobiological, and therapeutic effects of psychedelic substances” like psilocybin for decades..

Using a Schedule 1 drug in a clinical setting creates a set of unique problems, including the inability to use insurance. “Even though it’s a research program, you are treating them clinically. And then, in order to treat them clinically, you need to have malpractice coverage,” said Yale researcher Ben Kelmendi. Kelmendi and his team are about to embark on a first-of-its-kind study, a pilot program at Yale.

Research on the medical benefits of  psilocybin have been severely hampered due to legal restrictions, Kelmendi said. Only certain qualifying conditions are acceptable in this case. PTSD, for instance, is a complex issue that many people fail to treat.

“With veterans, they will not seek treatment right away,” Kelmendi said. “They will start turning to alcohol or other substances, and so that now they have a comorbidity, and that comorbidity—which really is their own way of coping—will exclude them from the study. They are real patients who are actually suffering and who actually need help. They cannot access these medicines because they do not fit that cookie-cutter profile.” 

The impact of PTSD is hard to define as it affects multiple aspects of daily life.

“There is no one scale that actually captures the complexity of one’s daily functional impairment. It’s actually an index of several different scales,” he said. “One is days missed at work, productivity and relationships, just more daily living. I think that is much more important than saying ‘Oh, have your PTSD symptoms improved or not?’”

Participants will take 25 mg of synthetic psilocybin, enough to induce a psychedelic experience, and the therapy is patient-directed. They will be taken in a comfortable space and about six hours later, participants will undergo a psychotherapy session. 

“Twenty-five milligrams would be considered a moderate dose. It’s not a heroic dose necessarily, but it’s a psychoactive dose, for sure,” Kelmendi said. “The non-directive supportive psychotherapy is to be done after the dosing rather than during the dosing.”

The Many Potential Health Benefits of Psilocybin 

The Yale Program for Psychedelic Science supports this goal with several currently active studies on psilocybin. These include studies on Obsessive Compulsive Disorder (OCD), Major Depressive Disorder (MDD), cluster headaches, post-traumatic headaches, and migraines. Kelmendi is working on several of them.A 2022 report published by a working group under the direction of the Connecticut Department of Mental Health and Addiction Services, was clear about the potential of psilocybin in therapeutic medicine. 

Even people who don’t necessarily intend to gain benefits for mental health from psilocybin are still benefitting, a separate study suggests. A study published last September found that using psilocybin outside of a clinical setting was associated with mental health benefits including decreases in anxiety and depression. The research, which was published September in the journal Frontiers in Psychiatry, studied nearly 3,000 people who reported on their experience taking psilocybin mushrooms. 

To conduct the study, which is reportedly the largest study of psilocybin in a naturalistic (non-clinical) setting, researchers spent two years collecting data from 2,833 participants who planned to take psilocybin for purposes of “self-exploration.” Most participants were college-educated white men in the United States who had previous experience taking psychedelic drugs.

The study participants were asked to fill out five surveys as part of the research. The first survey was completed two weeks prior to the psilocybin experience, which usually consisted of ingesting dried mushrooms, and again the day before the planned psychedelic trip. The remaining surveys were taken one to three days after the experience, two to four weeks after and two to four months after taking the psilocybin. 

After analyzing the data from the surveys, researchers determined that participants reported long-lasting reductions in anxiety, depression, alcohol misuse, neuroticism and burnout. Additionally, the participants reported improvements in cognitive flexibility, emotion regulation, spiritual well-being and extraversion. The new research aims to add to the body of knowledge of what is known about the effects of psilocybin.

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A city councilmember in Atlanta has proposed a measure that could open the door for both psilocybin and ketamine treatments.

The councilmember, Liliana Bakhtiari, believes that health plans for city workers should include the treatments, which research has shown to be effective in combating mental health disorders such as PTSD.

“We should be offering our employees — and especially our first responders, who are expected to be superhuman — the same amount of grace and providing them with a tool set to essentially overcome this issue,” Bakhtiari said in an interview with Axios.

Per Axios, the proposal “tasks the city’s HR department with studying the pros and cons of ketamine and psilocybin to treat mental health issues and whether the employee health plan could cover the treatments.”

The outlet adds that “ketamine can be taken under the care of a psychiatrist” in Georgia, and that Bakhtiari “says she has used ketamine therapy to treat past trauma,” and that “some sessions can cost roughly $350 out of pocket.”

As a councilmember, Bakhtiari has been a vocal champion of the treatment and drug reform.

In 2022, Bakhtiari introduced a resolution that would have “formally request[ed] that police make it ‘the lowest law enforcement priority’ to investigate or arrest people for ‘planting, cultivating, purchasing, transporting, distributing, engaging in practices with, or possessing Entheogenic Plants, Fungi, and Spores or plant compounds,’” Marijuana Moment reported at the time.

With a growing body of research on the efficacy of psychedelics as a mental health treatment, more lawmakers across the country have pushed for reform.

Earlier this year in Vermont, lawmakers passed a measure to set up a working group to look into psychedelics and their application in therapy.

Maryland Gov. Wes Moore signed a similar bill into law earlier this month. The measure will create the “Task Force on Responsible Use of Natural Psychedelic Substances,” a 17-member panel that will make recommendations designed to “[enable] broad, equitable, and affordable access to psychedelic substances.”

The law requires the task force to make the recommendations “regarding any changes to State law, policies, and practices needed to create a program that enables broad, equitable, and affordable access to psychedelic substances; and requiring the Task Force to report its findings to the Governor and the General Assembly on or before July 31, 2025.”

Meanwhile, a bill recently introduced in the New York Assembly would legalized psilcoybin service centers.

The proposal would change the existing law “in relation to promoting the health and well-being of the citizens of the state of New York by establishing a comprehensive framework supporting public health and safety through regulated adult use, support services, and cultivation of psilocybin-containing fungi.”

Additionally, the bill would seat up the “Regulated Psilocybin Advisory Board,” comprised of 13 members who would be charged with studying laws and policies pertaining to psilocybin, and then provide recommendations to the state’s Department of Health. Per the text of the bill, the board would “develop a long-term strategic plan for ensuring that psilocybin services in the state will become and remain a safe, accessible and affordable therapeutic option, including in therapeutic and medical treatments, for all persons eighteen years of age and older for whom psilocybin services may be appropriate.”

A study published earlier this year revealed that individuals with major depressive disorder experienced improvement in their symptoms following intravenous ketamine infusion therapy.

The report, based on a clinical trial involving 75 patients across four sites in the United States, was published in the Journal of Affective Disorders.

The patients “received 3 IV ketamine infusions over an 11-day period.” 

“Key exclusion criteria were psychotic symptoms, significant substance abuse, unstable medical conditions, and any use of cannabis. Pre-existing antidepressant medication was maintained. Primary outcome was remission as measured by Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcome of 50 % reduction in Beck Suicide Scale score. Safety monitoring and varying durations of infusions were also key parameters,” the authors of the study wrote. 

“The consistency of outcomes across 4 clinical sites and across multiple instruments, suggests high acute efficacy and safety of IV ketamine for serious depressive episodes. Duration of infusion did not alter outcomes,” the authors wrote in their conclusion. 

“Meaningfully, 40 % of non-responders after a single infusion did reach remission subsequently, while only 20 % of non-responders after 2 infusions achieved remission, suggesting early response is suggestive for eventual remission. Our data on varying ketamine infusion duration adds novel insights into the clinical administration of this new treatment for refractory and severe patients. Our limitations included a lack of a control group, necessitating caution about conclusions of efficacy, balanced by the utility of reporting “real-world” outcomes across multiple clinical sites. We could also not separately analyze results for bipolar disorder due to small numbers. Together, the Bio-K clinical results are promising and provide significant sample sizes for forthcoming biological markers analyses.

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As it turns out, researching the efficacy of MDMA to treat PTSD may be pretty complicated. The initial efforts to secure governmental sanction for a psychedelic substance for mental health care, in this case, MDMA, are facing some serious scrutiny over the clinical trial process, the Washington Post reports. 

MDMA has long been lauded as a treatment for PTSD, which affects 6% of the U.S. population. Per a Multidisciplinary Association for Psychedelic Substances (MAPS) 2023 study on how the drug can treat PTSD, the researchers found that, as High Times reported, in the MDMA group, 86% showed improvement in their standard PTSD assessment. 69% of those in the placebo group also improved. A standard PTSD assessment evaluates the intensity of PTSD symptoms, which can include anxiety, phobias, insomnia, and emotional numbness, among others. When the study wrapped, 72% of people within the MDMA treatment group no longer matched the criteria for PTSD, compared to 48% of the placebo participants.

Given how awful PTSD can be and, to be honest, how fun (and effective) MDMA can be compared to other treatment methods, this research was generally met with enthusiasm. While SSRI antidepressants like Zoloft are FDA-approved to treat PTSD, research shows it’s not always effective. The study in question shows that it had a response rate of 60%, which is obviously lower than the 86% improvement rate that came with MDMA.

However, per an independent analysis into the reliability of patient studies that are backing the Food and Drug Administration (FDA) application for MDMA, apparently, it’s pretty tricky to discern how effective these results are. Compared to other treatments, there are some serious hurdles associated with studying and then implementing psychoactive substances such as MDMA. 

While the bliss that MDMA can bring is generally considered a plus, it may make it trickier to study. One of the biggest challenges that arose when looking at the MDMA trial is that participants in the placebo group, who received a fake version of MDMA, could tell they hadn’t received the real thing because they experienced no changes in perception or euphoria, so it was rather obvious that they were in the placebo group, as noted in a draft report by the nonprofit Institute for Clinical and Economic Review (ICER). This lack of “blinding” in the trial, crucial for assessing the drug’s impact, potentially compromises the validity of the results.

The second hiccup when studying MDMA for PTSD came from the possibility that therapists were skewing the results. They basically thought that the therapists who were a part of the trial, there for mental health support, were biased in favor of MDMA, perhaps along with the participants, many of whom had previous positive experiences with the drug and, as a result, couldn’t provide the neutral ground required for a reliable study. 

The report also highlighted worries that participants who received MDMA felt “pressured to report good outcomes and suppress bad outcomes,” per the Washington Post. It also pointed to a documented instance of therapist misconduct that heightened safety concerns. While MDMA can be used to treat PTSD for sexual assault survivors, the psychedelic community may have some damage control of their own that needs a reckoning. Apparently, the ICER staff talked to folks who were part of a New York Magazine podcast investigating the MAPS’s clinical trial, in particular, patients who said they were victimized by therapists or coerced into reporting beneficial outcomes. According to one account, a woman in a MAPS trial states she was abused by her assigned therapists. 

ICER staffers, after speaking with several former patients and individuals associated with MAPS trials, observed that some adverse effects mentioned in the trial were not captured in the data they reviewed. While MDMA could help relieve horrid symptoms of PTSD, which include self-harm and thoughts of suicide, both of those were also included in the side effects (for both the MDMA group and those who got a placebo). People who have taken MDMA recreationally sometimes speak of “suicide Tuesday,” aka the crash after enjoying the spike of the drug on the weekend, and not only does this appear to roar its head within the trials, but those who spoke on the subject voiced concerns that there may be underreporting of such negative side effects. 

While some of this seems shocking when laid out in print, remember that none of the adverse claims or concerns are news to those in the psychedelic community. There is no medicine that exists without side effects; the silver bullet is a myth. If one finds healing through psychedelics, enjoy it while understanding the well-established risks (and benefits) that come with such a medicine. 

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There’s yet another compelling reason to legalize weed. According to new research, states that have legalized cannabis also experience a “moderate relative decrease” in immigrant deportation rates compared to states where the drug is still illicit.

As a study featured in the American Journal of Community Psychology details, immigration raids and deportations create widespread fear and mistrust, which have cascading effects throughout entire communities. As the fear of being targeted grows, people are less likely to engage with local institutions such as churches, schools, health clinics, cultural events, and social services. 

And it also finds that kids who experience the sudden, forced deportation of a parent often suffer from a range of psychological issues including anxiety, anger, aggression, and withdrawal. They may also exhibit a heightened sense of fear, trouble eating and sleeping, PTSD, and depression. While these conditions can be treated with cannabis and therapy, the research on legalizing cannabis and deportation indicates that we could get in front of such troubles if we just legalize it, to begin with. 

Of course, it’s not just immigrants, although better immigration policy benefits everyone. The study, conducted by researchers from Columbia University, also notes a slight reduction in overall cannabis-related arrests.

The authors of the study stated that recreational cannabis laws (RCLs) could “help to mitigate some of the unintended immigration-related consequences of cannabis prohibition.” They observed that “Arrest trends in both legalization and non-legalization states were relatively similar and generally stable over the period.” They also found that the trends suggested that the overall prevalence of deportations went down between 2009 and 2020.

Here’s a bit more of what they had to say:

“Our results suggest that the RCLs were associated with a moderate relative decrease in deportation levels that was observed relatively consistently across multiple model specifications. Findings also suggested potential relative decreases in immigration arrest levels; however for almost all specifications, associated confidence intervals were wide and included the null. Together these findings support the overall possibility that RCLs may help to mitigate some of the unintended immigration-related consequences of cannabis prohibition.”

About ten percent of U.S. families with children have at least one family member who doesn’t have citizenship, and it’s estimated that nearly six million kids have at least one caregiver without authorization to live in the country, putting them at risk for the aforementioned trauma and related mental health conditions. 

The authors of the study didn’t draw definitive conclusions about the apparent link between state-level cannabis legalization and reduced deportations. However, it is noteworthy that all 11 sanctuary states for immigrants (California, Colorado, Connecticut, Illinois, Massachusetts, New Jersey, New York, Oregon, Rhode Island, Vermont, Washington, D.C.), which generally discourage reporting immigrants to federal authorities, have also legalized cannabis for adult use.

The research leads to the conclusion that legalization generally results in fewer arrests for cannabis-related offenses, suggesting that fewer immigrants are likely to be implicated in marijuana criminalization from the get-go.

The researchers identified two “countervailing pathways” that they described as “relevant to anticipating the potential immigration implications of RCL adoption,” which are as follows: 

“First, RCLs could lead to potential decreases in the overall number of cannabis-related arrests or convictions, and therefore cannabis-related immigration enforcement. A second possibility, however, is that state adoption of RCLs might lead more people who are non-citizens to reasonably but falsely assume that federal immigration status is unaffected by cannabis use permissible under state law—potentially leading to increases in immigration enforcement.”

So basically, simply legalizing marijuana for everyone will naturally lower the number of people who are deported for daring to enjoy weed. However, there is also a chance that if recreational cannabis laws are passed, people who aren’t legal citizens might feel an unfortunately safe, false sense of security. 

The study explains that even though some states have legalized cannabis, don’t forget that it’s still illegal under federal law. This means that any cannabis-related offenses, even seemingly minor ones, can have serious repercussions for non-U.S. citizens such as permanent residents, DACA recipients, and those granted asylum. According to federal policy, simply being charged with or admitting to possessing a small amount of cannabis can lead to problems with U.S. Immigration and Customs Enforcement (ICE), including affecting immigration status or even leading to arrest, detention, or deportation. This is also true for those who work in the cannabis industry, further narrowing the scope of available labor to immigrants. 

So while yes, legal weed on a state level could lead to people feeling too comfortable and forgetting that there’s still the federal government to fear, overall, recreational laws seem to make life easier for everyone, as this new research into its implication on immigration shows. 

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A new study shows that natural mushroom extracts may be more therapeutically effective than synthesized psilocybin, which is widely used in research investigating the medicinal potential of the psychedelic drug. The findings suggest that natural mushroom extracts may offer more potential applications for the treatment of serious mental health conditions such as depression, post-traumatic stress disorder (PTSD) and schizophrenia.

The study, which was conducted by an interdisciplinary team of researchers from the Hebrew University of Jerusalem’s Hadassah Medical Center BrainLabs Center for Psychedelic Research, compared the effects of the natural and synthesized versions of psilocybin, the compound primarily responsible for the psychoactive effects of magic mushrooms.

“My colleagues and I are very interested in the potential of psychedelics to treat serious, treatment resistant psychiatric disorders such as depression, PTSD, OCD and even schizophrenia,” study author Bernard Lerer, a professor of psychiatry and director of the Hadassah BrainLabs Center for Psychedelic Research at Hebrew University, told PsyPost.

“There are many anecdotal and clinical reports which suggest that extract of psilocybin-containing mushrooms may have unique effects that are qualitatively and quantitatively different from chemical psilocybin, and also some preclinical studies,” Lerer continued. “This observation has important clinical implications and we wanted to test it empirically in a laboratory study.”

Entourage Effect May Boost The Therapeutic Effects Of Psilocybin

Mushrooms that contain psilocybin also produce many other psychoactive and non-psychoactive compounds that may work together to provide enhanced therapeutic effects through a phenomenon known as the entourage effect. However, most clinical research into psilocybin is conducted with synthesized forms of the drug that do not contain these additional potentially therapeutic compounds. 

“In Western medicine, there has historically been a preference for isolating active compounds rather than utilizing extracts, primarily for the sake of gaining better control over dosages and anticipating known effects during treatment,” the researchers said in an emailed statement about the study. “The challenge with working with extracts lay in the inability, in the past, to consistently produce the exact product with a consistent compound profile.”

“Contrastingly, ancient medicinal practices, particularly those attributing therapeutic benefits to psychedelic medicine, embraced the use of extracts or entire products, such as consuming the entire mushroom,” they continued. “Although Western medicine has long recognized the ‘entourage’ effect associated with whole extracts, the significance of this approach has gained recent prominence.”

To conduct the study, the researchers compared the effects of a natural mushroom extract with those of synthesized psilocybin in laboratory mice. The mice were divided into three groups that received either the extract, synthesized psilocybin or a saline solution control. Both forms of psilocybin were given in amounts determined to be therapeutically relevant based on equivalent dosing models between humans and laboratory mice.

The researchers assessed the behavioral effects and potential neuroplasticity induced by psilocybin using the head twitch response assay, a commonly employed method of studying the effects of psychedelics in mice. They also compared the metabolic changes in the frontal cortex following treatment and analyzed the expression of synaptic proteins in the brain that can be used as indicators of neuroplasticity.

The research showed that the mushroom extract demonstrated a stronger and more prolonged impact on synaptic plasticity, which could indicate the extract offers unique therapeutic benefits. Additionally, the metabolic analyses showed distinct metabolic profiles between synthesized psilocybin and the extract, suggesting that the mushroom extract may have a “unique influence on oxidative stress and energy production pathways,” according to a report from Neuroscience News.

While the research showed that the mushroom extract and synthesized psilocybin had different metabolic and neuroplasticity effects, both induced the head twitch response. The findings suggest that the acute effects of both compounds are similar at the basic behavioral level.

“We were surprised by the fact that there were no differences in the acute effect on the head twitch response between chemical psilocybin and psilocybin-containing mushroom extract while the differences emerged in terms of longer term effects on synaptic proteins and metabolomics,” Lerer said. “This has important potential clinical relevance.”

The researchers noted that while the mushroom extract showed potentially enhanced therapeutic effects, creating them in consistent formulations can be a challenge, making synthesized versions of the compound a common alternative for therapeutic research. However, they noted that with careful cultivation and processing, it is possible to make extracts in consistent formulations.

“A major challenge with natural extracts lies in achieving a consistently stable compound profile, especially with plants; however, mushrooms present a unique case,” the researchers wrote. “Mushroom compounds are highly influenced by their growing environment, encompassing factors such as substrate composition, CO2/O2 ratio, light exposure, temperature, and microbial surroundings. Despite these influences, controlled cultivation allows for the taming of mushrooms, enabling the production of a replicable extract.”

The researchers recommended more research, noting that there could be clinical advantages to using a natural mushroom extract instead of synthesized psilocybin.

“Our findings need to be confirmed in human studies but they do suggest that there may be therapeutic advantages to psilocybin-containing mushroom extract over chemically synthesized psilocybin, when both are administered at the same psilocybin dose,” said Lerer.

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The Missouri House Veterans Committee recently passed a medical psilocybin bill that would legalize psilocybin therapy for veterans and also grant funds for research on further therapeutic benefits.

Currently the House bill is unpublished, but an identical Senate version of the bill was also passed recently as well. SB-768 was pre-filed in December 2023 by Sen. Holly Thompson Rehder and was most recently passed in the Senate Committee on Emerging Issues on Feb. 27, with revisions to allow military veterans over 21 to use psilocybin if they suffer from post-traumatic stress disorder or substance use disorders. Other qualifications include a requirement to “enroll or sought to be enrolled” in a study focused on psilocybin treatment and must also share their diagnosis and psilocybin use and possession with the Department of Mental Health (DoMH).

The restrictions include limiting psilocybin use to a maximum of 150 mg during a 12-month period.

Missouri’s “Right to Try” law allows people with terminal illnesses to gain legal access to experimental drugs. This law also applies to the psilocybin bill. “Additionally, this act modifies current law on the use of investigational drugs and devices for individuals with terminal illnesses to include individuals with life-threatening or severely debilitating conditions or illnesses,” the SB-768 states. “Currently, investigational drugs shall not include Schedule I controlled substances. This act repeals that prohibition.”

As psilocybin patients are required to enroll in research initiatives, the DoMH is granting “$3 million dollars for research on the use and efficacy of psilocybin for the treatment of conditions listed in the act, with such appropriation being made from the Opioid Addiction Treatment and Recovery Fund.” The results and recommendations of this will be prepared and delivered to the governor, lieutenant governor, and general assembly every year.

The research would cover “the use of psilocybin, for the treatment of patients suffering post-traumatic stress disorder, major depressive disorder, substance use disorders, or who require end-of-life care.”

According to the current bill text, if passed, it would take effect in August 2024.

Rep. Aaron McMullen introduced the House version of SB-768 during the 2024 session. As a veteran who served in Afghanistan, McMullen has a personal connection to veterans’ needs. “Substance abuse and suicide are escalating in the veterans community,” said McMullen told The Independent in January. “While psilocybin is not a panacea for every issue, it represents a first true scientifically-validated hope that we have to address this crisis.”

In a statement to the Senate Judiciary and Civil Jurisprudence Committee in January, Rehder also explained the need to stand up for veterans across the state. “Many of our veterans experience high amounts of PTSD due to serving their country—due to protecting us,” Rehder said. “There should be no limits for them when it comes to access to mental health treatment, including non-pharmacological treatments.”

More support came from veteran William Wisner, who is executive director of the veteran-focused nonprofit organization Grunt Style Foundation. “My experience with these types of modalities has been that the side effects make you more empathetic,” said Wisner. “They make you kinder. They make you more open to kindness. It gives you a psychological and spiritual component to which you can engage in your own recovery.”

Wisner admitted that he never would have tried psilocybin treatment if he didn’t see the transformative results in his fellow peers. Committee Chairman Dave Griffith echoed that sentiment, telling The Independent that times have changed. “If you would have told me 10 years ago that I would be chairing a committee and listening to psychedelics, I would have told you, ‘You’re crazy,’” Griffith said. “But I really have a passion for the struggles that my veteran brothers and sisters are going through, and I think we’ve got to look at the big picture.”

Research on psilocybin is changing the minds of legislators across the country. 

On Jan. 24 in Hawaii, a psilocybin bill aims to protect patients who choose to seek out psilocybin as a treatment for “post-traumatic stress disorder (PTSD), treatment-resistant depression or major depressive disorder, end-of-life anxiety, existential stress, and demoralization, anorexia, bulimia, and other eating disorders, addiction, obsessive compulsive disorder.”

One bill proposed in Arizona on Feb. 2 would legalize psilocybin therapy programs, if passed. Toward the end of February, the New Mexico Senate also recently passed memorial legislation to permit the study of psilocybin and also research regulatory framework proposals.

Psilocybin support isn’t limited to the U.S. In Canada, 79% of residents support psilocybin use to treat existential dread for end-of-life patients. According to study leader Michel Dorval, a researcher at CHU de Québec-Université Laval Research Center, the evidence is increasing. “Studies have already shown that psilocybin, combined with psychotherapy, produces rapid, robust and lasting anxiolytic and antidepressant effects in patients suffering from advanced cancer,” Dorval said. “This substance can bring about a profound awareness that leads the patient to view existence from a different perspective. Treatment with psilocybin, combined with psychotherapy, can produce relief for up to six months.”

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Ukrainian President Volodymyr Zelensky has formally enacted legislation to legalize medical marijuana in a move that he and other leaders believe will assist soldiers in healing from both physical and psychological injuries suffered in the country’s ongoing conflict with Russia.

As of January 2, 2024, per Russia Matters, a project launched by Harvard University, Ukraine’s military has seen over 130,000 individuals killed, severely wounded, or missing. The number of civilian deaths totals 10,058. And this doesn’t count for the trauma endured. 

As many readers with trauma from other sources likely know, cannabis has demonstrated its therapeutic properties for folks experiencing PTSD. It can lower anxiety, improve sleep, decrease the frequency of PTSD nightmares, and also help with chronic pain management. Cannabis can also regulate mood and lift depression symptoms that frequently accompany traumatic experiences. There’s also research that cannabis also affects memory processing, which can ease the suffering surrounding recalling traumatic memories and flashbacks. 

In December, Ukrainian legislators initially passed the medical cannabis bill, but the Batkivshchyna party, in opposition, stalled its progress by insisting on a vote on a resolution to annul the measure. They apparently view the bill as a threat to the integrity of the country’s future. But in a win for survivors of the war, this resolution was defeated in January, effectively removing any obstacles to the bill’s enactment.

Critics attempted to thwart the legislation by submitting hundreds of amendments, which were called out as “spam” by detractors. However, this effort also proved unsuccessful. The bill passed with 248 votes in its favor.

Approximately one month after the legislative progress was freed up, on Wednesday, President Zelensky granted his final endorsement to the bill after the failed attempt to overturn the reform. The legislation is slated to become effective within six months from its official publication date. During this interim period, the Cabinet of Ministers of Ukraine, along with the Ministry of Health, is responsible for formulating the regulations for the program.

As Reuters notes, over 6 million people, including soldiers, civilians with PTSD, and healing soldiers, require cannabis. Although the initial version of the bill specifically mentions only cancer and PTSD resulting from the nation’s ongoing war with Russia, which began when Russia invaded Ukraine two years ago, as qualifying conditions for medical cannabis use, the chair of the health committee noted that legislators regularly receive feedback from patients suffering from other conditions, including Alzheimer’s disease and epilepsy, indicating a broader demand for access to medical cannabis.

Ukraine might begin the importation of marijuana products earlier than the aforementioned six months, following the reclassification of cannabis from being completely banned under List I to being permissible for medical purposes with a prescription under List II in the nation’s drug code.

Zelensky expressed his approval for the medical marijuana legalization back in June, telling parliament that, “all the world’s best practices, all the most effective policies, all the solutions, no matter how difficult or unusual they may seem to us, must be applied in Ukraine so that Ukrainians, all our citizens, do not have to endure the pain, stress and trauma of war.” He further noted the steps required to make this happen, stating: “In particular, we must finally fairly legalize cannabis-based medicines for all those who need them, with appropriate scientific research and controlled Ukrainian production.”

The bill outlines the requirement for specific licenses to grow and sell cannabis, including a mandate for round-the-clock video monitoring of production sites, which will be accessible to law enforcement. Oversight of cannabis cultivation and processing will fall under the jurisdiction of the Ministry of Agrarian Policy. Furthermore, the National Police and the State Agency on Medicines will have supervisory and enforcement powers concerning the distribution of the medicinal product.

In December, the Defense Department unveiled a security assistance package worth up to $250 million for Ukraine. This package includes anti tank weaponry, air defense systems, artillery, and additional equipment designed to support Ukraine’s ongoing efforts to fight back against the unprovoked aggression. And cannabis companies stepped up as well.

During the initial month of Russia’s invasion last year, several American cannabis firms offered financial aid to Ukraine. Misha Breyburg, CEO of MediThrive, contributed a portion of the proceeds from cannabis sales to a charity assisting Ukrainians. Additionally, Breyburg had the MediThrive dispensary located in San Francisco’s Mission District decorated in Ukraine’s national blue and yellow colors.

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After hitting a brief snag late last year, a bill approved by Ukraine’s unicameral legislature in December to legalize medical cannabis in the country appears to be back on track.

The delay occurred when the opposing Batkivshchyna (Fatherland) party and its leader, Yulia Tymoshenko, announced the party’s intention to appeal to the Constitutional Court to cancel the legislative vote, citing that “the amendments to the bill were considered in a half-empty chamber.”

Tymoshenko, who has been vocally opposed to the reform measure, also said that the bill would legalize “drug trafficking and the drug mafia” in Ukraine, while European Solidarity co-chair Irina Herashchenko argued that the bill’s text focused on industrial production and lacked clear rules around state regulation.

This week, the Verkhovna Rada, Ukraine’s parliament, unblocked the bill after the resolution failed, earning only 25 of the required 226 votes to repeal the parliament’s adoption of the law. The bill was then formally sent to President Volodymyr Zelenskyy’s desk on Wednesday, who has publicly voiced his support.

Overcoming the Efforts of Opposing Parties

According to a Ukrinform report, the announcement was first made on Tuesday by MP Yaroslav Zhelezniak from the Holos party on Telegram. Zhelezniak announced the status of the bill alongside a number of other recent legislative updates.

The Verkhovna Rada adopted the law on Dec. 21, regarding regulation of “the circulation of cannabis plants for medical, industrial purposes, research, and scientific and technical activities to create conditions for expanding patient access to the necessary treatment of oncological diseases and post-traumatic stress disorders obtained due to war.”

The next day, the Batkivshchyna registered a draft resolution with the parliament to cancel the decision, though registering a draft resolution of that nature doesn’t allow the Verkhovna Rada chair and the president to sign the adopted legislative act. Rather, the document’s signing was able to be unblocked after the draft resolution was rejected.

Opponents previously tried to block the bill’s progress after introducing almost 900 amendments to the bill, dubbed “spam” amendments by critics, in November.

Ukraine’s Pending Medical Cannabis Legislation

The measure to legalize medicinal cannabis looks to license the economic activity for hemp cultivation for medical, industrial and scientific purposes. Additionally, the law aims to help Ukrainian war veterans with post-traumatic stress disorder (PTSD), along with providing relief to those with cancer and other serious illnesses. The legislation only explicitly references that it will “create conditions for expanding the access of patients to the necessary treatment of oncological diseases and post-traumatic stress disorders obtained as a result of war,” with no mention of other qualifying conditions.

The bill would also move cannabis from strictly prohibited in the current List I to availability for medical use with prescription under List II of Ukraine’s drug code. 

According to lawmaker Yaroslav Zhelezniak, the distribution of cannabis for recreational use will still be a crime, and the production of cannabis medicines will be “strictly controlled” at all stages. Only those with an electronic medical cannabis prescription would be allowed to obtain cannabis-based medicines.

The measure received support from Ukraine’s Health Ministry, which called the move a “historic decision.”

“Thank you on behalf of the medical community for the decision made, because medical cannabis is a medicine for millions of people: cancer patients, people with multiple sclerosis, patients receiving palliative care, etc.,” the Health Ministry’s translated statement reads.

In June 2023, Zelenskyy emphasized the need for the reform specifically highlighting the ongoing Russia-Ukraine war and, more broadly, those Ukrainians who may benefit from cannabis-based medicines.

“All the world’s best practices, all the most effective policies, all the solutions, no matter how difficult or unusual they may seem to us, must be applied in Ukraine so that Ukrainians, all our citizens, do not have to endure the pain, stress and trauma of war,” Zelenskyy said in a statement. “We must finally honestly legalize cannabis-based medicines, relevant scientific research, and controlled Ukrainian production for everyone who needs it.”

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A bill, introduced by GOP state Sen. Ed Charbonneau, would establish “the therapeutic psilocybin research fund,” which would be “administered by the Indiana department of health (state department), to provide financial assistance to research institutions in Indiana to study the use of psilocybin to treat mental health and other medical conditions,” according to the official text of the legislation.

Additionally, the measure would require a “research institution that conducts a clinical study to prepare and submit a report to the interim study committee on public health, behavioral health, and human services, the state department, and the division of mental health and addiction.”

According to the Evansville Courier & Press, the fund would subsidize research institutes to study whether psilocybin could make for an effective treatment for those with post-traumatic stress disorder, anxiety, depression, bipolar disorder, chronic pain and migraines, and it would “require the studies to prioritize veterans and first responders: groups with a higher likelihood to suffer from the above disorders, especially PTSD.”

“Before taking part, participants would undergo mental evaluations, the bill states. After the studies wraps, researchers would then determine how mushrooms stack up against currently accepted treatments for the targeted issues,” the newspaper said. “They would then ship the results to an ‘interim study committee,’ as well as the state health department and the division of mental health and addiction.”

The bill is the byproduct of the Indiana interim study committee on Public Health, Behavioral Health and Human Services, of which Charbonneau serves the chair.

In the fall, the committee recommended that the Indiana legislature authorize a psilocybin pilot program. 

According to Cannabis News, the committee was tasked in June with studying “a number of topics related to mental health matters, including psychedelic-assisted therapy.” 

“Specifically, they were charged with studying alternative treatment options that had been given ‘breakthrough therapy’ status by the U.S. Food and Drug Administration and examining policies ‘enacted and under consideration in other states’ that allow psilocybin-assisted therapy ‘for veterans, first responders, and others experiencing mental illness,’” the outlet reported.

Cannabis News said that the panel ultimately recommended that the legislature authorize “state research institutions ‘to conduct a pilot clinical study utilizing established therapeutic protocols as a starting point to explore the efficacy, safety, and feasibility of psilocybin assisted therapy in Indiana.’”

Charbonneau said at the time that he had held discussions with both Indiana University Health and Purdue University about the research program.

“I spoke to 150 pharmacy students at Purdue, and afterward had a chance to speak with the dean of the pharmacy program,” the lawmaker said, as quoted by Cannabis News.

Charbonneau said that the dean texted Dr. Jerome Adams, a former United States surgeon general in the Trump administration who is now Presidential Fellow and the Executive Director of Purdue’s Health Equity Initiatives.

“We’ve had a talk,” Charbonneau said at the time, regarding his conversations with the universities. “They’re interested in possibly moving forward, but that’s just a preliminary talk.”

As the outlet Benzinga noted, the clock is ticking for the bill to be approved.

The proposal was “filed as an emergency measure, meaning it would take effect immediately upon passage, which could come as early as this week,” according to Benzinga, noting that officials “would need to establish fund administration and application processes by July 1.”

“While the bill creates the fund, it doesn’t initially allocate any money. Donations, gifts and state appropriations would fill its coffers. After completing research, the funded institutions must report their findings and recommendations to various entities, including the Department of Health and an interim study committee on health issues,” the outlet said.

Psilocybin’s therapeutic benefits have long been touted by advocates, but the substance has only recently been championed by elected officials and policymakers. Emboldened by the shifting public opinion, activists have also tried to usher in reform themselves. 

In California, a campaign to get a psilocybin proposal on the state’s ballot this year said this week that it had fallen short of that goal. 

According to Marijuana Moment, this marked the “the third election cycle that Decriminalize California has made a play for the ballot, only to fall short amid what organizers say is a variety of complicating factors, including voter confusion over a failed legislative push for psychedelics decriminalization and separate reform campaigns also seeking to put their measures before voters.”

“As exhausting as this process has been, we’ve learned some extraordinary techniques that we’re going to put into effect for something much larger than this as it was, because psychedelics was basically a delivery mechanism for a better society,” Ryan Munevar, campaign director of Decriminalize California, said. “That was the goal, at least.”

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