The company, MAPS Public Benefit Corporation, said that it had completed “confirmatory phase three” of the multi-site study, which “met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (‘CAPS-5’) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (‘SDS’).”

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. 

Last week’s announcement comes after the company said in November that it had completed “the second of two Phase 3 pivotal trials.” 

“Now with two positive Phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year,” Emerson said last week. 

The study, known as “MAPP2,” was “a randomized, double-blind, multi-site Phase 3 study of the efficacy and safety of MDMA-assisted therapy for the treatment of PTSD,” the company said last week.

“The study enrolled 121 participants and of those enrolled 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. The MAPP2 study enrolled participants with PTSD for the 12-week treatment period. The MAPP2 participants reflected the U.S. demographics of those living with PTSD with people of color representing more than half of those enrolled in the study,” the company said in a press release. 

Founded in 2014, MAPS Public Benefit Corporation says that its vision is to create a “world where all people have opportunities to heal and grow through psychedelic medicines and therapies.​”

The company’s mission statement reads: “Lead the research, development, and integration of psychedelic medicines and therapies into the healthcare system, prioritizing purpose over profits.​”

That mission has been buttressed by the the U.S. Food and Drug Administration, which in 2017 “granted MDMA-assisted therapy Breakthrough Therapy designation, a process designed to expedite development and review of drugs intended to treat serious conditions and that demonstrate substantial improvement over available therapies,” the company said in last week’s press release.

“Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Emerson said in 2017. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”

The company said last week that it “expects to submit the new drug application to the FDA in the third quarter of 2023.” 

“MAPS PBC plans to submit the full data set for publication in a peer-reviewed journal,” the press release said. “MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.”

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Benjamin Han, M.D., the lead author of the study and a geriatrician in the Division of Geriatrics, Gerontology, and Palliative Care in the Department of Medicine at UC San Diego School of Medicine, said that the dramatic increase in emergency room visits related to cannabis consumption among older adults is a concern for many physicians in his field. In an interview with UC San Diego Today, he noted that the increase is significant because older adults are at a higher risk of adverse effects associated with cannabis and other psychoactive substances.

“Many patients assume they aren’t going to have adverse side effects from cannabis because they often don’t view it as seriously as they would a prescription drug,” said Han. “I do see a lot of older adults who are overly confident, saying they know how to handle it — yet as they have gotten older, their bodies are more sensitive, and the concentrations are very different from what they may have tried when they were younger.” 

The study, which was funded in part by the National Institute on Drug Abuse, was conducted using a trend analysis of data obtained from the California Department of Healthcare Access and Information. The researchers determined that the number of cannabis-related emergency department visits among adults in California aged 65 and up jumped from 366 in 2005 to 12,167 in 2019. Medical marijuana was legalized in California in 1996, and regulated sales of adult-use cannabis began in the state on January 1, 2018, following the legalization of recreational marijuana by the state’s voters in 2016. The study found that while emergency room visits jumped sharply between 2013 and 2017, they then leveled off, suggesting that the availability of recreational marijuana did not increase the risk of a visit to the emergency department.

Cannabis Use Increasing Among Older Americans With Legalization

Over the past two decades, the consumption of cannabis by older adults has increased sharply as marijuana legalization efforts gained ground across the United States. Older Americans are increasingly using cannabis socially and for a variety of health conditions, leading to a drop in the perceived risk of regular marijuana use.

The researchers say that the new study illustrates that cannabis use among older adults can lead to unintended consequences that require emergency health care for a variety of reasons. The use of cannabis can slow reaction time or impair attention, which may increase the risk of injury or falls. There is also evidence that cannabis can increase the risk of delirium, paranoia, or psychosis and that using marijuana can interact with prescription medications or exacerbate pulmonary or cardiovascular problems.

“We know from work in alcohol that older adults are more likely to make a change in substance use if they see that it is linked to an undesirable medical symptom or outcome — so linking cannabis use similarly could help with behavioral change,” said Alison Moore, M.D., co-author of the study and chief of the Division of Geriatrics, Gerontology, and Palliative Care in the Department of Medicine at UC San Diego School of Medicine. “We truly have much to learn about cannabis, given all the new forms of it and combinations of THC (tetrahydrocannabinol) and CBD (cannabidiol), and this will inform our understanding of risks and possible benefits, too.”

The study reveals the need for older Americans to have honest discussions about their use of cannabis with their healthcare provider. Moore says that such conversations should be an element of routine medical care, but screening protocols often include the use of cannabis with the use of illicit drugs.

“Instead, asking a question like, ‘Have you used cannabis — also known as marijuana — for any reason in the last 12 months?’ would encourage older adults to answer more frankly,” Moore said. “Providers can then ask how frequently cannabis is used, for what purpose — such as medically for pain, sleep, or anxiety or recreationally to relax — in what form (smoked, eaten, applied topically) and if they know how much THC and CBD it contains. Once the provider has this type of information, they can then educate the patient about potential risks of use.”

Han agreed that patients should discuss their cannabis with their doctors before deciding to use it for medical purposes.

“Although cannabis may be helpful for some chronic symptoms, it is important to weigh that potential benefit with the risk, including ending up in an emergency department,” he said.

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That is the finding of a new study from researchers at the University of Michigan that was published in JAMA Network Open last week. 

The researchers contacted 1,724 adults, 96% of whom (1,661) completed the full survey. 

Among them, “31.0%…of adults with chronic pain reported having ever used cannabis to manage their pain; 25.9%… reported using cannabis to manage their chronic pain in the past 12 months, and 23.2%… reported using cannabis in the past 30 days,” the researchers wrote. 

The researchers said that “more than half of adults who used cannabis to manage their chronic pain reported that use of cannabis led them to decrease use of prescription opioid, prescription nonopioid, and over-the-counter pain medications, and less than 1% reported that use of cannabis increased their use of these medications.” 

“Fewer than half of respondents reported that cannabis use changed their use of nonpharmacologic pain treatments,” they wrote in their findings. “Among adults with chronic pain in this study, 38.7% reported that their used of cannabis led to decreased use of physical therapy (5.9% reported it led to increased use), 19.1% reported it led to decreased use of meditation (23.7% reported it led to increased use), and 26.0% reported it led to decreased used of cognitive behavioral therapy (17.1% reported it led to increased use).” 

Thirty-seven states in the U.S. have medical cannabis programs on the books. Among adults living with chronic pain in those states, “3 in 10 persons reported using cannabis to manage their pain,” according to the new study.

“Most persons who used cannabis as a treatment for chronic pain reported substituting cannabis in place of other pain medications including prescription opioids. The high degree of substitution of cannabis with both opioid and nonopioid treatment emphasizes the importance of research to clarify the effectiveness and potential adverse consequences of cannabis for chronic pain,” the researchers wrote. “Our results suggest that state cannabis laws have enabled access to cannabis as an analgesic treatment despite knowledge gaps in use as a medical treatment for pain. Limitations include the possibility of sampling and self-reporting biases, although NORC AmeriSpeak uses best-practice probability-based recruitment, and changes in pain treatment from other factors (eg, forced opioid tapering).” 

The findings serve as another source of encouragement for advocates who hope patients continue to seek treatment from cannabis, rather than highly addictive prescription drugs. 

According to the Center for Disease Control and Prevention, “more than 564,000 people died from overdoses involving any opioid, including prescription and illicit opioids, from 1999-2020.”

The CDC says that the “rise in opioid overdose deaths can be outlined in three distinct waves.”

“The first wave began with increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids (natural and semi-synthetic opioids and methadone) increasing since at least 1999,” according to the CDC. “The second wave began in 2010, with rapid increases in overdose deaths involving heroin. The third wave began in 2013, with significant increases in overdose deaths involving synthetic opioids, particularly those involving illicitly manufactured fentanyl. The market for illicitly manufactured fentanyl continues to change, and it can be found in combination with heroin, counterfeit pills, and cocaine.”

Mark Bicket, one of the authors of the new study who also serves as assistant professor in the Department of Anesthesiology and co-director of the Michigan Opioid Prescribing Engagement Network, said that the “fact that patients report substituting cannabis for pain medications so much underscores the need for research on the benefits and risk of using cannabis for chronic pain.”

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Researchers at San Diego State University and Bentley University performed the study, which they said is the first to explore the impacts of recreational cannabis laws on employment, wages and labor market outcomes of working-age individuals. They used data from the 2002-2020 Current Population Survey Merged Outgoing Rotation Groups, along with various difference-in-difference approaches including TWFE and Callaway and Sant’Anna estimators.

Ultimately, the researchers said they found “little evidence that RMLs [recreational marijuana laws] adversely affect labor market outcomes among most working-age individuals.”

Rather, they found evidence of “modest increases” in employment and wages, especially among those over the age of 30 (often shorter-run gains), younger racial/ethnic minorities and those working within the agricultural sector. 

“These results are consistent with the opening of a new licit industry for marijuana and (especially for older individuals) a substitution away from harder substances such as opioids,” researchers said.

The working paper’s introduction begins with two contrasting quotes from Elon Musk and Seth Rogan—Musk’s quote, “I’m not a regular smoker of weed … I don’t find that it is very good for productivity,” and Rogan’s, “I smoke a lot of weed when I write.”

The paper’s focus was not on cannabis and productivity among individuals, though a number of recent studies have explored that question with conflicting results. One 2022 study concluded cannabis use has no effect on motivation, though a 2016 study suggested improved performance and cognitive function for cannabis users. Others have concluded cannabis use could indeed lead to lower motivation.

Instead, this analysis explored broader economic trends following recreational cannabis legalization. Ultimately, the authors said that cannabis reform has introduced a new industry, which ultimately creates jobs and opportunities for the working class. 

In addition to the bustling job opportunities, researchers said that legal cannabis access keeps more people away from other substances, like opioids or heavy alcohol use, that can lead to negative effects on productivity. They also note that, if cannabis is effective in improving physical or psychological health symptoms, these improvements could also work to generate “positive labor market spillovers.” 

With legal cannabis, there is also reduced criminalization surrounding possession, once again allowing for better labor market outcomes, especially among young Black and Hispanic men, who have “disproportionately suffered diminished labor market opportunities due to having a criminal record,” researchers said.

Due to the relatively new market, researchers said the study was limited simply based on the limited period available to analyze. 

“Longer-run labor market effects may differ as we learn about the effects of RMLs on cognitive development and human capital acquisition of those under age 21, which could take time to unfold and be reflected in market level effects on productivity, wages, and/or employment,” they concluded. “Moreover, the labor market effects of reductions in criminal records could also take time to unfold.”

Researchers also said that it’s difficult to confirm how the new legal industry will evolve over time, citing the initial COVID-19 period as a “dramatic increase” for cannabis sales and the period following it “one of dramatically declining sales.”

“Nonetheless, our findings answer some important early questions about the economic consequences of recreational marijuana legalization,” authors said.

Previous studies have confirmed an association between recreational cannabis laws and increased employment levels among older adults. Data compiled last year by Leafly and Whitley Economics also shows the cannabis industry added more than 100,000 new jobs in 2021 and employed more than 428,000 full-time workers at the time of its release.

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“Over the past four years, the data collected under the Racial and Identity Profiling Act has provided empirical evidence showing disparities in policing throughout California,” the report states. “This year’s data demonstrates the same trends in disparities for all aspects of law enforcement stops, from the reason for stop to actions taken during stop to results of stop.”

The report spans stop data that occurred between January 1, 2021 to December 31, 2021, and analyzes information from 58 law enforcement agencies and the negative impacts of citizen interactions with police, with a focus on youth.

In the 2021 timeframe, more than 3.1 million stops were reported. In terms of “perceived” race or ethnicity, police agencies states that 42.2% were Hispanic/Latine(x), 30% white, 15% Black, 5.3% Asian, 4.8% Middle Eastern/South Asian, 1% multiracial, 0.5% Pacific Islander, and 0.3% Native American. Additionally, 72.1% were cisgendered male and 27.5% cisgendered female, making up 99.7% of all stops.

Reasons for a law enforcement “stop” include either a traffic violation (86.6%), or a reasonable suspicion of being engaged in criminal activity (10.5%). Black individuals had the highest percentage of stops in regard to “reasonable suspicion” at 16.2%, but also the lowest proportion of stops for traffic violations (80.5%).

The RIPA Board found that Black and Hispanic/Latine(x) individuals were more likely to have force used against them compared to White individuals. Black teens between the ages of 10-14 and 15-17 experienced the highest rate of being searched by police (20.1%), detained (17.9%), and handcuffed (15.4%), and “removed from a vehicle by order” (7.6%).

Black adolescents were detained curbside or in a patrol car 36.2%-44.5% of the time, searched 39.9%-42.4% of the time, handcuffed 33.5-36.5% of the time. Ultimately, this data shows that teens who are perceived to be Black were searched six times the rate of White adolescents, and those perceived to be Hispanic/Latine(x) were searched four times more.

The interactions that teens have with law enforcement, including repeat interactions, impact those individuals’ mental health. “Research shows that the types of contact and frequency of involuntary contacts with law enforcement may have a harmful impact on the individual stopped, triggering stress responses, depressive symptoms, anxiety, and other related negative mental health impacts,” the report states. “This research suggests that racial and identity profiling goes beyond the criminal legal system and policing; it is also a critical public health issue.”

“Based on the research, the Board believes that public health officials and policymakers should treat racial and identity profiling and adverse policing as significant public health issues. It is imperative to recognize that police interactions can negatively affect the mental and physical health of individuals who are Black, Hispanic/Latine(x), Indigenous, and people of color. Doing so could help significantly reduce the high stress, community fragmentation, and poor health outcomes among community members who experience targeting of their neighborhoods and aggressive policing practices. Given this, adequate resources should be invested to understand and address the health implications of racial and identity profiling.”

This report covers a variety of information relative to the discussion of how law enforcement abuses the system through pretextual stops or searches, an act where an officer stops an individual for a minor violation in order to closer “investigate a hunch regarding a different crime that by itself would not amount to reasonable suspicion or probable cause.”

While the report does not specifically delve into details in regards to cannabis, The Washington Post published a story in October 2022 about the racial disparities in law enforcement in Virginia. Although the state legalized adult-use cannabis in July 2021, the article put a spotlight on how Virginia police are still more likely to arrest Black people more than White people for cannabis-related offenses.

An analysis of cannabis arrests by the New York Police Department (NYPD) in 2020 showed that 94% of all cannabis-related arrests impacted people of color. Overall, cannabis arrests by the NYPD in 2022 have been reduced, but arrests were still higher for those perceived as Black or Hispanic.

In April 2020, the American Civil Liberties Union (ACLU) published an extensive report showing the disparity of arrests for Black individuals, showing that arrests are still widespread and racial disparities are still common throughout the country, both in states with legal or decriminalized cannabis.

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Magnetic resonance imaging (MRI) is a process that uses strong magnetic fields and radio waves to create noninvasive images of the body, its organs, and biological functions. Images created through MRI can provide healthcare professionals with a wealth of data about their patients, but the confining space and loud noises of an MRI machine can cause discomfort and anxiety for many people who undergo the procedure. MRI manufacturers have responded by making more patient-friendly machines, but being subjected to an MRI scan can still be an unwelcome and stressful experience for many patients.

To address the issue, researchers at the Turner Institute for Brain and Mental Health at Monash University in Australia are conducting a study to investigate how psilocybin affects participants during an MRI scan of 60 healthy participants. Dubbed PsiConnect, the research is the first of its kind in Australia and is one of the world’s largest psychedelic trials to use brain imaging technology, according to the researchers. In 2021, the Australian government announced it would provide $15 million in funding to investigate the potential use of psychedelics to augment psychotherapy.

“Finding people was hard because we wanted people who had never taken this drug before and don’t have any mental health history, even in their first-degree relatives,” Adeel Razi, a neuroscientist from the Monash Turner Institute for Brain and Mental Health and the lead researcher for the study, told the Sydney Morning Herald. 

Study participant Michael Taylor fit the bill perfectly. In his late 40s, he was healthy and had never used drugs recreationally.

“I hadn’t been that kind of person, you know,” said Taylor. “I’ve never even smoked a cigarette in my life.”

Study Participants Receive Small Dose Of Psilocybin

To conduct the study, the participants will undergo an MRI examination both before and after taking a small, sub-therapeutic dose (19 milligrams) of synthetic psilocybin. Researchers will then use the images produced during the MRI to assess any potential changes in activity after the administration of the psychedelic drug. The researchers hope that the information gleaned from the imaging combined with data from other evaluations will provide information that can be used to develop new drugs and therapies to more effectively treat mental illnesses. 

“I can look at how the brain is reacting to these compounds, and that gives me a window into understanding consciousness,” said Razi. “We need to have the evidence base of how it actually works in a brain without depression, and then the insights that we get, we can translate into use in a clinical setting.”

After he had been administered psilocybin and was put in the MRI machine, Taylor said that the loud, clanking noises created by the imaging were anything but distressing.

“It was the most magical music that I have ever heard,” said Taylor.

Taylor remembers the music rising to a crescendo like a wave, which eventually broke over him and flooded him with joy.

“I felt myself smiling, laughing; I’m sure I giggled at one point,” he said. “I was thinking: ‘I can’t believe this is happening. Why don’t more people get to experience this?’”

As the imaging process progressed, Taylor says that he lost all sense of self.

“I actually felt myself melding with the MRI machine and becoming one with it,” Taylor remembers. “Which is crazy – but that’s what it was like, I was just part of everything else around me. I was everything. And everything was me.”

About 60% of the participants said that the experience with psilocybin was one of the most meaningful and spiritually significant experiences of their lives. Among those who did not find the experience spiritually significant or meaningful, slightly less than half still said it was one of the most interesting or amazing experiences of their lives. About 10% of the participants said that they did not experience much of an effect from the psilocybin and about 5% said that they experienced unpleasant effects. Razi said that the initial findings of the research will be published in about six months.

“We will make all the imaging data and behavioral data open access,” he said. “It is one of the largest studies in the world, and anyone will be able to analyze the data, so it will have a long-lasting legacy.”

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Insomnia involves difficulty falling or staying asleep and is relatively common, experienced by up to 30% of the general population. In their introduction, the authors point to the potential for cannabis to help alleviate sleep dysfunction along with the impact of individual cannabinoids on sleep. Specifically, they reference the sedative effect of THC and the potential of CBD as a sedative in higher doses.

The trial looked to assess the tolerability and effectiveness of medicinal cannabis oil on sleep in adults with insomnia. The study was conducted between May 2020 and May 2021 at the National Institute of Integrative Medicine in Melbourne, Australia. Researchers assessed the use of a cannabis oil product, versus placebo, in 29 subjects with chronic insomnia. 

Each extract contained 10mg of THC and 15mg of CBD per milliliter, along with a lesser amount of other cannabinoids and naturally occurring terpenes, and each participant consumed either the extract or a placebo for a two-week period. Participants were instructed to take the oil in the evening with food, increasing their doses by 0.1ml (1mg THC/1.5mg CBD) increments each day, starting with 0.2ml on the first day and maxing out at 1.5ml (15mg HC/22.5mg CBD).

The six-week study consisted of a one-week run-in period, a two-week intervention period, a one-week wash-out period and a second two-week intervention period, with four total assessments taken at the start and completion of each intervention phase. Primary outcome measures included saliva midnight melatonin levels and insomnia symptoms assessed by the ISI questionnaire.

Ultimately, investigators reported that participants using cannabis extracts experienced improved sleep quality by up to 80%, and 60% of participants were no longer classified as clinical insomniacs at the end of the two-week intervention period. Four of the total participants (14%) had no side effects, while 24 (83%) reported non-serious side effects, possibly related to the active medication, like dry mouth, diarrhea, nausea and vertigo. 

Researchers also noted that, aside from dry mouth, all side effects were only experienced on one or two non-consecutive days. About half of the participants in the active group reached the maximum dose over two weeks, though 20% stopped increasing their dose at 0.4-0.6ml due to side effects like vertigo or dizziness. Two participants reported more serious side effects, acute onset tachycardia (accelerated heart rate) and extreme dizziness, both of which were alleviated by lowering the dose.

At the conclusion of the trial, all but one participant (96%) found that cannabis oil was an acceptable treatment for insomnia, and the majority of participants (79%) requested an ongoing prescription for the medicinal cannabis oil, even the participant who had tachycardia. Five of the six participants who chose not to continue taking the cannabis oil cited reasons other than side effects (like work restrictions, driving a vehicle) for discontinuing treatment.

“Our short-term trial suggests Entoura 10:15 medicinal cannabis oil, containing THC:CBD 10:15 and lesser amounts of other [cannabinoids] and naturally occurring terpenes, to be well tolerated and effective in significantly improving sleep quality and duration, midnight melatonin levels, quality of life, and mood within 2-weeks in adults with insomnia,” researchers concluded. “Long-term studies are needed to assess whether chronic medicinal cannabis intake can restore natural circadian rhythm without the need for ongoing cannabis intake.”

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There is no cure for ASD or similar conditions, so many families resort to behavioral therapies, with few other options on the table. But a rise in alternative therapies involving cannabis or psychedelics is forming, with notable promise from psilocybin.

A study published in the journal Psychopharmacology examined the effects of psilocybin microdoses on Fragile X syndrome (FXS)—a leading cause of autism. FXS is the most common form of inherited intellectual disability (ID) and the leading cause of ASD involving one gene. 

Researchers gave different doses of psilocybin to test rats and then tested their cognitive abilities. They examined cognitive deficits displayed by the recently validated Fmr1-Δexon 8 rat “model of ASD,” which is also a model of FXS, and how psilocybin plays a role. 

The study, “Psilocybin mitigates the cognitive deficits observed in a rat model of Fragile X syndrome,” examined rat microdoses of psilocybin for 5-14 day periods.

Serotonin insufficiencies during childhood may have an impact on brain patterning in neurodevelopmental disorders, manifesting as behavioral and emotional symptoms, researchers explained in the study. And since psilocybin stimulates serotonergic signaling, it may offer promise as effective early interventions for developmental disorders such as ASD and FXS.

Researchers first gave rats a single large dose of psilocybin and then tested any changes to their cognitive abilities, finding some improvements. Rats that did not have FXS led to reductions in cognitive performance. 

Researchers then gave another group of rats microdoses over the course of five days, giving them cognition tests daily. 

They observed improvements in all of the rats to the extent that their cognition results were nearly identical to rats that did not have FXS. Researchers ran the experiment again, extending it to two weeks, and they found identical results.

“Our results revealed that systemic and oral administration of psilocybin microdoses normalizes the aberrant cognitive performance displayed by adolescent […] rats in the short-term version of the novel object recognition test—a measure of exploratory behavior, perception, and recognition,” researchers wrote.

The data supports existing theories of how psilocybin may affect the production of serotonin and thus help people living with cognitive and emotional conditions.

“These data support the hypothesis that serotonin-modulating drugs such as psilocybin may be useful to ameliorate ASD-related cognitive deficits. Overall, this study provides evidence of the beneficial effects of different schedules of psilocybin treatment in mitigating the short-term cognitive deficit observed in a rat model of FXS.”

The goal is to eventually commence clinical trials of psilocybin on human patients. 

Researchers across the board are experimenting with psilocybin (as well as several cannabis compounds) to treat ASD and other autism-related conditions.

One Canadian research team has studies already underway. Dr. Max Jones and Dr. Gale Bozzo, two professors at University of Guelph’s Ontario Agricultural College (Department of Plant Agriculture), received a Health Canada “dealer’s license” on Oct. 25. The license permits the cultivation of psilocybin mushrooms, and is one of the first universities in Canada to be permitted to do so.

Dr. Melissa Perreault, Professor in Ontario Veterinary College’s Department of Biomedical Sciences, has experience and has previously involved studies of the molecular and cellular mechanisms associated with medical conditions like depression or ASD. Her plan is to examine the signaling pathways that psilocybin might affect.

More research is needed to determine psilocybin’s efficacy for the treatment of ASD in human trials.

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The model for legal psychedelic therapy, and most research looking at the efficacy of psychedelics for mental health treatments, is generally understood through psychedelic therapy centers. For states that have legalized psychedelic substances like psilocybin, or any number of ketamine clinics already operating in the U.S., this typically involves a combination of talk therapy, a controlled psychedelic dose, and supervision/guidance from a licensed professional.

But what about psychedelic retreats? These tailor-made psychedelic getaways typically take place in countries where psychedelic substances are allowed, similarly helping patients seeking symptom relief, or often a general mental reset, in a luxurious setting. 

Now, the public psychedelics practitioner training program F.I.V.E. has announced plans to collaborate with Tandava Retreats and University College London (UCL) on the first-ever EEG brain imaging study of 5-MeO-DMT among retreat center participants, Benzinga reports. 

Study collaborators are generally looking to uncover more information on 5-MeO-DMT’s mechanism of action and specifically within naturalistic settings over medical/clinical settings, along with how retreat participants could be better served as they use the substance in this setting.

The study’s principal investigator Jeremy Skipper said it’s important to look at the actual contexts these psychedelics are used in order to best understand the effects of such substances. 

“We hope to contribute not only to a better scientific understanding of how 5-MeO-DMT works in the brain, but also to enabling individualized approaches that maximize the efficacy of 5-MeO-DMT therapies and retreats,” Skipper told Benzinga.

Tandava CEO Joel Brierre, who is also the CEO of F.I.V.E., will coordinate the study along with F.I.V.E. President Victoria Wueschner. It will gather both qualitative and quantitative data from Tandava participants, assessing changes in well-being, beliefs, and personality. The study will use spontaneous neural imagery electroencephalography (EEG) on participants both before and during the psychoactive experience.

“These retreats allow you to explore the deepest realms of your innermost being, address behavioral habits that no longer serve you, and give you the freedom of life that you seek,” the Tandava website states. “We believe that no one should be a victim of their own mental patterning.”

Tandava is located in Tepoztlan, Mexico, and has the amenities anyone might expect on a tropical vacation: a hot jacuzzi, sauna, communal spaces, plenty of food and drink and private rooms for all visitors. With practitioners and integration specialists with varying backgrounds, Tandava offers a number of options, including a “transcultural” framework, an Indigenous/Shamanic approach, even a journey grounded by yoga. 

The site also mentions that each Tandava guide has been on their own psychedelic journey. 

Research has already affirmed that 5-MeO-DMT used in a naturalistic group setting can improve depression and anxiety, though of course there’s still a lot of catching up to do to fully understand its impacts, and the impacts of other psychedelic substances. The compound generally comes from the Sonoran Desert toad, Bufo alvarius, though Tandava Retreats uses synthetic 5-MeO-DMT to support species conservation and sourcing sustainability.

“We have found the experience of synthetic 5-MeO-DMT to be identical in nature to the toad secretion, which is important to note during the rise in popularity of this medicine,” Brierre told Benzinga. “Not only is synthetic safer and more effective to use with participants, but it has the repeatable consistency and precision dosage needed for proper research to be done.”

The study will cost about $108,437, though a U.K.-based charity has already donated $40,898 to the cause. Tandava will also match any funds raised and will donate retreat and integration costs for 15 of the 30 participants. There is also a crowdfund available for those interested in supporting the study.

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The findings were published Monday in the peer-reviewed journal Clinical Toxicology, pinpointing precisely 338,727 instances of intentional abuse or misuse amongst American children aged 6-18. Americans did a fairly good job of keeping drugs away from young children, however, as most of the cases involving smaller children 6-12 were accidental and usually involving over-the-counter items such as vitamins and hormones.

Among American youth, cannabis use rose 245% since 2000 in the U.S., while alcohol abuse has steadily declined over the same period. “Young people are ditching alcohol for marijuana,” Neuroscience News reports.

“Ethanol abuse cases exceeded the number of marijuana cases every year from 2000 until 2013,” stated Dr Adrienne Hughes, Assistant Professor of Emergency Medicine at Oregon Health & Science University, one of the authors of the study. “Since 2014, marijuana exposure cases have exceeded ethanol cases every year, and by a greater amount each year than the prior.” 

“These edible and vaping products are often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” says Hughes.

Researchers pointed out what most of us already know: that problems associated with cannabis usually involve edibles that take hours to creep up.

“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms of marijuana usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” says Hughes.

Researchers noted 57,488 incidents involving children aged just 6 to twelve, but they were cases involving vitamins, plants, melatonin, hand sanitizers, and other typical household objects.

A slight majority of cannabis ingestions were noted in males versus females at 58.3%, and more than 80% of all reported cannabis exposure cases occurred in teens aged 13 to 18.

The report illustrates how drugs fall into and out of favor over time. Dextromethorphan—the most reported substance over the study period—peaked in 2006, but has fallen out of favor among American youth.

Youth alcohol abuse peaked over 20 years ago back in 2000, when the largest number of abuse cases involved exposure to ethanol. Since then, child alcohol abuse has steadily declined over the years.

Cannabis cases, on the other hand, remained relatively stable from 2000 to 2009, with a rise in cases beginning in 2011, and a more acute rise in cases from 2017 to 2020.

The same pattern can be seen as fewer American youth are drinking alcohol. Changes in the types of cannabis products that are being consumed is also apparent. But the rise in unpleasant edible experiences is a concern for the team of researchers.

“Our study describes an upward trend in marijuana abuse exposures among youth, especially those involving edible products,” says Hughes.

“These findings highlight an ongoing concern about the impact of rapidly evolving cannabis legalization on this vulnerable population.”

The findings are not exactly conclusive: Previous, federally funded data dismisses the theory that legalization measures have a correlation with increased teen use of cannabis.

A study published in November in the journal American Journal of Preventive Medicine found that cannabis legalization “was not significantly related” to “the probability or frequency of self-reported past-year cannabis use” by teens. It also found that “youth who spent more of their adolescence under legalization were no more or less likely to have used cannabis at age 15 years than adolescents who spent little or no time under legalization.”

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