Individuals in a survey reported greater gratitude, nature relatedness, and nature appreciation after embarking on an ayahuasca retreat experience. 

The active chemical in ayahuasca is DMT (dimethyltryptamine) and it also contains monoamine oxidase inhibitors (MAOIs) that play a role. The survey respondents rated effects on several scales to determine which effects were most prominent.

PsyPost reported Tuesday that 65 participants were observed who attended a well-known ayahuasca retreat in Costa Rica frequented by Americans. The study, “Effects of Ayahuasca on Gratitude and Relationships with Nature: A Prospective, Naturalistic Study,” was published recently in the Journal of Psychoactive Drugs. The study was led by Jacob S. Aday and a team of researchers associated with Central Michigan University in Mount Pleasant, Michigan. Aday was assisted by Emily K. Bolesch, Alan Kooi Davis, Sarah E. Domoff, Kyle Scherr, Josh D. Woolley, and Christopher C Davoli.

Sixty-five participants attended the Soltara Healing Center in Puntarenas Province, Gigante, Costa Rica. Soltara is an all-inclusive ayahuasca retreat center where attendees pay to participate in ayahuasca ceremonies with indigenous Shipibo curanderos (plant healers) from Peru. It’s attracted celebrities such as former New York Jet and commentator Aaron Rodgers. As compensation for their participation, study authors entered participants in a drawing to potentially win $100.

The participants stayed at the Soltara center for 5-12 nights and participated in 2-7 ayahuasca ceremonies during their stay. Participants received an email with the study survey, and in it, they completed assessments of gratitude using an Appreciation Scale, relatedness to nature using a Nature Relatedness Scale, and the appreciation of nature using an Appreciation of Nature Scale.

The second survey contained the same three assessments from the first one, plus more related to their ayahuasca experiences: mystical experiences during the ceremonies using an Mystical Experience Questionnaire, awe using an Awe Experience Scale, and ego dissolution using an Ego Dissolution Inventory.

Researchers observed that gratitude increased significantly after the retreat. Nature relatedness and appreciation of nature were also more pronounced after the retreat. These increases were more pronounced in participants who reported stronger mystical experiences.

“Here, participants completed validated surveys related to gratitude, nature relatedness, and nature appreciation one-week before, one-week after, and one-month after attending an ayahuasca retreat center,” the study reads. “Compared to baseline, there was a significant increase in gratitude, nature relatedness, and nature appreciation at the one-week and one-month follow-ups. Ratings of mystical-type experiences and awe, but not ego dissolution, during participants’ ayahuasca sessions were weakly-to-moderately correlated with these increases.”

Researchers were also able to learn several more things about the impact of an ayahuasca experience.

“The number of ayahuasca ceremonies attended at the retreat was not related to change in outcomes, underscoring the importance of the quality rather than the quantity of the experiences in post-acute change,” the study continues. “Lastly, participant age was negatively related to the occurrence of mystical-type experiences and awe, supporting literature indicating blunted psychedelic effects with increased age. In the context of study limitations, the results suggest that mystical-type experiences and awe occasioned by ayahuasca may be linked to prosocial changes in gratitude and relationships with nature that may be beneficial to mental health.”

Interestingly, the strength of ego dissolution experiences and the number of ayahuasca ceremonies attended were not associated with significant changes in the level of gratitude, appreciation of nature, and nature relatedness.

Other Effects of Ayahuasca

Many other potential uses for ayahuasca in therapy are being explored. A study published earlier this year, for instance, found that ayahuasca may help individuals become less narcissistic.

The findings, published in April 2023 in the Journal of Personality Disorders and based on a three-month evaluation of more than 300 adults, suggested that after “ceremonial use of ayahuasca, self-reported changes in narcissism were observed,” although the researchers did urge some caution.

“However, effect size changes were small, results were somewhat mixed across convergent measures, and no significant changes were observed by informants. The present study provides modest and qualified support for adaptive change in narcissistic antagonism up to 3 months following ceremony experiences, suggesting some potential for treatment efficacy. However, meaningful changes in narcissism were not observed. More research would be needed to adequately evaluate the relevance of psychedelic-assisted therapy for narcissistic traits, particularly studies examining individuals with higher antagonism and involving antagonism-focused therapeutic approaches,” the researchers wrote.

Another study published in the British Journal of Pharmacology in February explored how ayahuasca (shortened to AYA for the use in this study) and DMT interacts with serotonin receptors in the part of the brain that regulates fear.

In that study, ayahuasca was found to affect serotonin receptors in the infralimbic cortex of the brain, where fear is regulated.

With a better understanding of how ayahuasca impacts gratitude and a connectedness with nature, we can better understand how it could be applied in psychedelic-assisted therapy.

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An Arizona church has reached a settlement in a lawsuit against the U.S. Drug Enforcement Administration and other federal agencies that allows the Indigenous religious organization to use the psychedelic brew ayahuasca for sacramental purposes. Under the agreement, the Church of the Eagle and the Condor (CEC) will be permitted to import, prepare and distribute ayahuasca to its members at religious ceremonies.

“The Church of the Eagle and the Condor has reached a settlement to secure its religious freedom and the right to use Ayahuasca as its sacrament,” the church wrote in an announcement of the settlement. “This is the first Indigenous-based church to receive recognition and protection.”

In 2022, the CEC filed a lawsuit against the U.S. Department of Justice, the Department of Homeland Security (DHS), Customs and Border Protection and the DEA after DHS officials seized shipments of ayahuasca intended for sacramental use by church members. The lawsuit also cited government threats that the church and its members could face prosecution under federal drug charges if they continued to import ayahuasca, which contains the psychedelic drug and Schedule I controlled substance DMT (N, N-Dimethyltryptamine).

The settlement allows the CEC and its members to obtain and use ayahuasca in paste or liquid form under an exemption to the Controlled Substances Act. The concentrate will then be diluted with water into a ceremonial tea by church members for religious ceremonial purposes held in Phoenix. The settlement permits the DEA to take samples of imported shipments to confirm they contain ayahuasca and no controlled substances other than DMT. 

“This Agreement permits CEC to import, receive, manufacture, distribute, transport, securely store, and dispose of ayahuasca solely for CEC’s religious purposes,” the settlement reads. “CEC may not conduct any of these activities for non-religious purposes, including but not limited to recreational purposes. CEC may not use any DEA registrations subject to this Agreement to import, receive, manufacture, distribute, store, or use any other controlled substance.”

Ayahuasca is used in South America by Indigenous cultures and folk healers in spiritual and religious ceremonies. In recent years, the psychoactive brew has gained popularity with American celebrities including Aaron Rodgers, Will Smith, Miley Cyrus and others, who have used ayahuasca to take advantage of its purported mental health benefits.

CEC Ayahuasquero (sacramental practitioner) Joseph Tafur, M.D. said in a statement that the ceremonial use of ayahuasca “is an essential sacrament for our church.”

“Our ceremony is rooted in the Shipibo Amazonian tradition which has been passed down by countless generations,” he said. “Now, in fulfillment of the ancient Prophecy of the Eagle and the Condor, this tradition has come to North America.” 

“I am honored to be an Ayahuasquero with the CEC, and bring to our ceremony the care, respect, and reverence that it deserves,” Tafur continued, adding, “Our ancestral practice will continue to support the community and nourish our holistic well-being.” 

Belinda P. Eriacho, a CEC board member of Diné and A:shwii lineages, said that the settlement with the DEA “reaffirms our right to practice our spirituality as we have always known. It is a recognition by the U.S. government and an important milestone in honoring and validating indigenous belief systems. Prior to contact, indigenous peoples have used sacred plant medicines for healing and ceremony since time immemorial.”

“Our relationship with our plant relatives has always been an extension of our worldview. This has been interrupted by the imposition of governmental policies that have suppressed our way of life and demonstrated religious intolerance,” Eriacho continued. “This settlement is a significant step and acknowledgment of our spiritual beliefs as original peoples of the Americas.” 

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A federal judge in California has ruled against a motion from the U.S. Attorney General’s office to dismiss a lawsuit filed by a church that uses the psychedelic brew ayahuasca as a sacrament. The suit was filed last year by the Church of the Celestial Heart after a shipment of ayahuasca to the church was intercepted by law enforcement officials.

The legal action, which names U.S. Attorney General Merrick Garland and other federal officials as defendants in the case, was filed by Jade Osborne, the wife of the Church of the Celestial Heart’s pastor Kai Karrel and the intended recipient of the shipment. After the ayahuasca shipment was intercepted, Osborne was arrested and criminally charged in 2021 by authorities in Tulare County, although prosecutors have not filed formal charges.

Osborne, the church, and additional plaintiffs maintain in the lawsuit filed in April 2023 that the federal government is forcing them to choose between practicing their religion or going against their beliefs to avoid prosecution by law enforcement.

“Ayahuasca is an essential sacrament for Karrel, without which he cannot practice his religion or provide services to the church’s members,” the church writes in its suit, according to a report from Courthouse News Service. “Despite these threats, Karrel intends to continue possessing and using the church’s sacrament — ayahuasca.”

In the legal action, the church is seeking preliminary and permanent injunctions barring Garland and federal officials from prosecuting members of the church for using ayahuasca. The suit also requests attorney’s fees and other forms of relief from the government.

AG Files Motion To Dismiss Case

The attorney general’s office filed a motion to dismiss the case, maintaining that the church did state a claim in its filing and does not have standing to file the suit because the seizure was not an injury caused by the named defendants in the case. Although the Department of Homeland Security seized the shipment of ayahuasca, an official with the Tulare County Sheriff’s Office investigated the case and arrested Osborne. The motion also requested that if the case was not dismissed, it be stayed until the church applies for a religious exemption to the Controlled Substances Act. 

U.S. Magistrate Judge Stanley A. Boone ruled against the attorney general’s office on all counts.

“The court finds plaintiffs have sufficiently alleged a genuine threat of imminent prosecution … and this supports the conclusion that plaintiffs have demonstrated standing,” the judge wrote in his decision.

Boone noted in his decision that church members intend to continue importing, possessing and using ayahuasca because the church cannot function properly without the sacrament. Members of the church also intend to continue using ayahuasca in its rituals, even with the threat of prosecution from federal and local authorities.

“Here, Celestial Heart alleges it has suffered both financial and spiritual loss having its sacrament confiscated and destroyed,” the judge wrote. “That it is substantially burdened by being forced to choose between following the tenets of its religion or being coerced to act contrary to its religious beliefs by the threat of civil or criminal sanctions; and that it intends to continue importing, possessing, and using its sacrament, for without its sacrament, the Church cannot provide essential services.”

Church members say they believe the ayahuasca was destroyed after it was seized. But the judge determined that even if the brew was destroyed, the threat of federal prosecution of church members could be traced back to the federal officials named in the lawsuit.

Boone also ruled against the attorney general’s motion to stay the case to allow the Drug Enforcement Administration to investigate the religious exemption claims made by the church.

Sean T. McAllister, a Denver attorney representing the Church of the Celestial Heart, declined a request from the Courthouse News Service to comment on the legal action.

“Here, Celestial Heart alleges it has suffered both financial and spiritual loss having its sacrament confiscated and destroyed,” Boone wrote. “That it is substantially burdened by being forced to choose between following the tenets of its religion or being coerced to act contrary to its religious beliefs by the threat of civil or criminal sanctions; and that it intends to continue importing, possessing, and using its sacrament, for without its sacrament, the Church cannot provide essential services.”

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A church that purportedly uses entheogenic plants like psilocybin mushrooms as a holy sacrament was raided by officers with the Detroit Police Department Friday just two days after having a newspaper article about them published in the Detroit Metro Times.

According to a follow up article by the Detroit Metro Times, officers confiscated about $700,000 Friday in psilocybin mushroom products as well as ayahuasca and iboga from Soul Tribes International Ministries at 15000 Southfield Freeway in Detroit. Officers with the Detroit Police Department confirmed the raid took place to the Metro Times but would not comment on what was taken or any other details about what happened there.

Owner of Soul Tribes, ‘Shaman Shu’ (formerly named Robert Shumake) said 15 officers from DPD showed up armed and masked, seized the mushroom products and ordered a closure of the church. Shu told the outlet he believes the actions taken by police were in violation of Proposal E, a 2021 city initiative that decriminalized the use of psychedelic plants and fungi like psilocybin.

“They stole ancient sacrament. It was prayed over and meditated over. It’s a healing sacrament… They blocked my property down without due process. You can’t do that,” Shu said to the Metro Times. “They think we’re not a church. But that’s why the federal government was created, to separate church and state so that cities do not opine on what churches are [and] what ministries are. We’re a ministry and a religious organization.”

The original article said Soul Tribes was operating a “sacrament center” within the church where they sold dried psilocybin fruits, capsules and gummies to church members based on language in Proposal E that included using psilocybin therapeutically under the supervision of religious leaders, though they remain illegal under Michigan state law.

Regardless, Proposal E did not allow for the sale of entheogenic plants and fungi, which is likely where Soul Tribes ran into trouble with the police. The Metro Times asked for comment from the Mayor of Detroit’s office regarding the raid and whether or not DPD’s actions were sanctioned by the City, to which they received the following comment from Doug Baker, the city’s assistant corporation counsel:

“The Detroit Police Department worked in close coordination with the city’s law department and building safety, engineering and environmental department in preparing this enforcement action,” Baker said. “It is the law department’s position that this local ordinance, despite its intent, does not override state law, which considers psilocybin to be a controlled substance. Most importantly, the city ordinance itself does not allow for the sale or distribution of psilocybin.”

DPD Sgt. for media relations, Jordan Hall, told the outlet, “My understanding was that [the raid] was due to a lack of licensing and the amount of substances that were distributed.”

Soul Tribes operates out of a long vacant church on the West side of Detroit on a 60,000 sq. ft campus which Shu purchased about three months prior to the raid. The church planned to open formally in November but the sacrament center opened over Labor Day weekend and Shu told the outlet all the products came from mushrooms he grew himself, citing the Religious Freedom Restoration Act as his legal defense for doing so.

“We have a right to our sacrament. We have a right to our belief system,” Shu said to the Metro Times before he was raided. “We’re a small indigenous belief system that believes we can heal the world with these techniques and our plants. You become a member of our church, just like you would any church, temple, or mosque. We’re no different.”

Shu had actually been in talks with DPD prior to the raid and emails reportedly obtained by the outlet showed they were working on setting up a meeting just the week prior.

“As you may already be aware, your ministry has definitely perked up some ears in the community,” said Sgt Crystal Johns in an email to Shaman Shu on Sept. 17. “Many of the questions and documented laws are above my understanding but the City’s legal team and our Police executives would like to have a conversation with you.”

No arrests appear to have been made and it was not immediately clear if Shaman Shu had any legal recourse for a lawsuit, though one Detroit attorney told the Metro Times Shu might have a precedent for his case. Shu maintained to the outlet that he was fulfilling his obligations as a religious leader and had a legal right to do what he was doing.

“We have a Percocet crisis, we have an Oxycontin crisis, and we have a fentanyl crisis,” Shu said. “It’s been proven that the sacred plant medicine has been used to heal people from mental health [issues], and that’s what this is about.”

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City officials in Berkeley, California have reportedly moved to decriminalize both psilocybin mushrooms and ayahuasca.

According to Psychedelic Spotlight, the city council there “unanimously” approved a measure to “officially deprioritize arrests for possession and use of psilocybin and ayahuasca…creating a new paradigm as dozens of cities across the United States move to recognize these naturally-occurring compounds’ mental health potential.”

SFGATE reported last week that the city council was slated to vote on the measure at Tuesday’s meeting.

The road to this psychedelic drug reform effort began in November, when the Berkeley City Council said that it would consider the measure.

The original resolution sought to decriminalize a host of psychedelics; along with psilocybin and ayahuasca, it also would have applied to LSD.

The measure that was ultimately approved on Tuesday was titled: “Resolution Supporting Entheogenic Plant Practices and Declaring that the Investigation and Arrest of Individuals Involved with the Adult Use of Entheogenic Plants on the Federal Schedule 1 List Be Amongst the Lowest Priority for the City of Berkeley.” 

It states that “the City of Berkeley wishes to declare its desire not to expend City resources in any investigation, detention, arrest, or prosecution arising out of alleged violations of state and federal law regarding the use of Entheogenic Plants,” and declares “that it shall be the policy of the City of Berkeley that no department, agency, board, commission, officer or employee of the city, including without limitation, Berkeley Police Department personnel, shall use any city funds or resources to assist in the enforcement of laws imposing criminal penalties for the use and possession of Entheogenic Plants by adults of at least 21 years of age.”

“For the purposes of this resolution, Entheogenic Plants are defined as plants and natural sources such as mushrooms, cacti, iboga containing plants and/or extracted combinations of plants similar to ayahuasca; and limited to those containing the following types of compounds: indole amines, tryptamines, phenethylamines,” the resolution continues.

The measure was pushed by a grassroots group called Bay Staters for Natural Medicine, which “led the effort to decriminalize six Massachusetts communities including Cambridge and Salem,” according to the outlet.

“Living in Berkeley, I tried psilocybin mushrooms for the first time with trusted friends. These plant medicines helped me work through trauma and open my heart to other people for the first time,” James Davis, cofounder of Bay Staters for Natural Medicine, told Psychedelic Spotlight. “Even so, this measure strikes the right balance by acknowledging that this should be something people research cautiously for their own wellbeing. Not something that should be sold and traded like candy, as has unfortunately happened in Oakland, nor commercialized for massive profits like in Oregon and Colorado.”

While this reform effort launched in earnest back in the fall, SFGATE notes that “Berkeley has been considering psychedelic reform since at least 2019, but the measure stalled during the COVID-19 pandemic because of disagreements over how to handle synthetic psychedelics.”

“Cities across the country have moved to reduce criminal penalties for using and distributing psychedelic drugs in recent years, as advocates argue that criminalization of drugs is not an effective way to regulate these substances,” the outlet reported. “The Bay Area has been a leader in the psychedelic reform movement, with Oakland, San Francisco and Santa Cruz passing similar measures that make possession of psychedelics a lower priority for law enforcement.”

Berkeley has been in the vanguard of other drug reform efforts, with the city council voting in 2020 to allow cannabis consumption lounges and marijuana delivery.

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A poll from the University of California, Berkeley Center for the Science of Psychedelics (BCSP) shows new data regarding American support of legal psychedelic therapy. The poll results were published online on June 20 in what the university calls the “first-ever Berkeley Survey,” which was also presented at the Psychedelic Science 2023 Conference in Denver, Colorado.

“More than six out of 10 (61%) American registered voters support legalizing regulated therapeutic access to psychedelics, including 35% who report ‘strong’ support,” UC Berkeley wrote in a press release regarding the poll. “In addition, more than three-quarters of voters (78%) support making it easier for researchers to study psychedelic substances. Almost half (49%) support removing criminal penalties for personal use and possession.”

Poll participants were asked to answer “support,” “oppose,” or “other” to two questions. First, they were asked what their response is to “creating a regulated legal framework for the therapeutic use of psychedelics.” Second, they were asked their opinion on “Obtaining FDA approval so that people can access psychedelics by prescription.”

The data is the result of “new longitudinal public opinion research project” conducted by university researchers, which tracks public beliefs related to psychedelic substance research, policy and cultural events. According to BCSP’s Executive Director Imran Khan, this data is just the beginning. “This is the first clear picture we have of what the American public think and feel about psychedelics. The Berkeley Psychedelics Survey shows that the majority of American voters are interested in, and supportive of, the field. They want fewer barriers to research for scientists, and they want regulated, therapeutic access for the public,” Khan said. “Amidst all the stigma and the hype about these powerful substances, it’s vital that researchers, policymakers, and practitioners can understand and respond to the public’s hopes and fears. We’re excited to reveal the full results of the Berkeley Psychedelics Survey in the coming weeks.”

Both Khan, as well as Berkeley Psychedelics Survey project lead, Taylor West, previewed the data at the Psychedelic Science 2023 Conference. “The level of national support for psychedelics policy reform far exceeded my expectations. Clearly much of the news around promising research and mental health results has begun breaking through to the general public,” West said on the stage.

The survey in its entirety will be published on July 12 in an online presentation by BCSP co-founder Michael Pollan, as well as Khan and West. Those interested in the digital presentation can register here.

On June 26, the BCSP announced on its Twitter page that it was be hosting a psychedelics course through the UC Berkeley Extension through the edX platform. The course, called “Psychedelics and The Mind, begins on August 1 and is taught by UC Berkeley Professor of Neurobiology David Presti. “In becoming a more informed citizen vis-à-vis psychedelics, you will have an opportunity to become better acquainted with your own brain and nervous system, understand the science related to organisms and molecules having psychedelic properties, gain historical and contemporary context surrounding factors that influence public opinion and law, and appreciate something of the rapidly evolving contemporary clinical research with these materials,” the course information states.

A brief look at the syllabus shows course coverage of “Foundational Concepts in the Neurobiology of Psychedelics” including substances such as LSD, psilocybin mushrooms, sacred cacti and mescaline, DMT, ayahuasca, and Amazonian snuffs, MDMA, ketamine, and nitrous oxide. To cover this wide variety of topics, Presti includes expert sources such as “Raquel Bennett, Susana Bustos, Gül Dölen, Andrea Gomez, Ayize Jama-Everett, Bob Jesse, Dacher Keltner, Mariavittoria Mangini, Jennifer Mitchell, Michael Pollan, Sylvestre Quevedo, and Forrest Tahdooahnippah.”

In another first for psychedelics, the U.S. Food and Drug Administration recently issued its first guidance for clinical studies on psychedelics on June 23. Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, released a statement about the agency’s recommendations for psychedelic study. “Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” Farchione said. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

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The United States Food and Drug Administration, aka the FDA, issued the first-ever guidance for clinical studies on psychedelics, according to a news release issued Friday. They filed the 14-page document shortly after Congress introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines.

They aimed the guidance specifically towards classical psychedelics, which include psilocybin, LSD, mescaline, and DMT, the psychoactive ingredient in ayahuasca, in addition to entactogens or empathogens such as MDMA. This means that it does not cover other drugs used therapeutically embraced by the psychedelic community, such as ketamine, which is technically a dissociative anesthetic that has hallucinogenic effects.

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov involving psychedelics. For instance, in January, MAPS Public Benefit Corporation, a biopharmaceutical company dedicated to psychedelic treatment, announced its Phase 3 clinical trial on MDMA-assisted therapy for post-traumatic stress disorder (PTSD) produced promising results.

“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. MAPS plans to submit the new drug application to the FDA in the third quarter of 2023.

Like MAPS’ study on MDMA, psychedelic research to date has primarily been backed by private sponsors. Many of these may want nothing to do with the Feds and their infamously regressive views on psychedelics. The FDA approval process is expensive and riddled with red tape. Many companies may prefer to follow state guidelines and leave psychedelics, such as psilocybin, which researchers currently study for OCD, and alcohol use disorder, nestled in the safety of libertarian-esque gray areas. (Oregon and Colorado are the only states to decriminalize the supervised use of psychedelics). 

For example, let’s look at ketamine, which, as noted, is not technically a psychedelic. While Esketamine, or S-ketamine, the S enantiomer of ketamine, is FDA-approved as a nasal spray, many ketamine clinics and psychiatrists prefer to prescribe patients actual ketamine, off-label, because it’s not only more affordable but may work better than the version the FDA approved, which was only changed to S-ketamine in the first place so Johnson & Johnson could patent it under the brand name Spravato. 

However, if a substance earns FDA approval, it is easier to market and sell and could reach more consumers who trust that it’s met the FDA decision that the benefits outweigh the risk. For instance, Tryp Therapeutics is currently seeking FDA approval for psilocybin-assisted therapy to help those with irritable bowel syndrome (IBS).

While such studies show that psychedelics hold great therapeutic potential, as anyone with personal experience using psilocybin, MDMA, or other psychedelics can attest, the FDA asserts that they must address the challenges associated with designing clinical studies to evaluate the safety and effectiveness of psychedelics.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry at CDER.1, Applied Clinical Trials reports. 

The guidance addresses the psychoactive and hallucinogenic effects of psychedelics, the potential for abuse, and the importance of conscientious safety measures. It includes considerations for the importance of characterizing dose-response and the durability of any treatments. The draft also tackles potential drug interactions for patients on antidepressants or mood stabilizers such as lithium. 

Additionally, for any Schedule I controlled psychedelics, the FDA states that the research must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements. 

It also tackles the role of psychotherapy within a psychedelic treatment, what folks in the community often describe as integration, or the therapeutic process of a patient going through therapy with a professional to integrate their experience into everyday life, ensuring that it’s not just a one-time trip, but an ongoing treatment plan. 

If anyone has thoughts on the draft guidance, the FDA accepts public comments for 60 days. 

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City leaders in Ferndale, Michigan voted this week to decriminalize psilocybin mushrooms and other natural psychedelics, making the city in the Detroit metropolitan area the fourth municipality in the state to reform laws prohibiting the promising drugs. The Ferndale City Council voted unanimously on February 27 to approve a resolution decriminalizing entheogenic plants and fungi including psilocybin mushrooms, ayahuasca, and dimethyltryptamine (DMT), all of which are psychedelics that show promise as treatments for a variety of mental health conditions.

The resolution passed by the city council does not legalize psychedelic drugs outright. Instead, the measure directs that the “investigation and arrest of persons for planting, cultivating, purchasing, transporting, distributing, engaging in practices with, or possessing Entheogenic Plants or plant compounds which are on the Federal Schedule 1 list shall be the lowest law enforcement priority for the City of Ferndale,” according to the text of the resolution.

The city council resolution was sponsored by Mayor Pro Tem Kat Bruner James. The measure was supported by Decriminalize Nature, a national organization working to reform psychedelics policies from coast to coast, and the Ferndale chapter of the activist group. 

“The Ferndale community continues to demonstrate mindfulness and integrity as we move towards collective well-being and community healing in allyship with nature and her medicines,” Decriminalize Nature Ferndale wrote in a social media post after the city council passed the resolution. “We are grateful for all the community support and to Ferndale City Council for passing the resolution to decriminalize entheogenic plants and fungi.”

Psychedelics As Plant Medicines

The two-page resolution includes findings from the city council recognizing that natural psychedelics have been used as plant medicines by humankind for thousands of years. The measure also notes that research has shown that the use of psychedelics can be beneficial to the health and well-being of communities and individuals.

“The use of Entheogenic Plants, which can catalyze profound experiences of personal and spiritual growth, have been shown by scientific and clinical studies and traditional practices to be beneficial to the health and well-being of individuals and communities,” the resolution reads.

After Monday’s vote, psychologist Billy Horton, the co-chair of Decriminalize Nature Ferndale, thanked the city council for the members’ unanimous support of the psychedelics decriminalization ordinance. The activist added that the group would continue to educate the public on the safe use of plant medicines.

“I just want to continue to emphasize the importance of psychedelic and entheogenic plants and the work that’s going on, the research and the science that’s supporting it for psychological and for physical wellness,” he told the council in a statement quoted by the Detroit Metro Times.

Ongoing research has shown that psilocybin has the potential to be an effective treatment for several serious mental health conditions, including PTSD, major depressive disorder, anxiety, and substance misuse disorders.

A study published in 2020 in the peer-reviewed journal JAMA Psychiatry found that psilocybin-assisted psychotherapy was a quick-acting and effective treatment for a group of 24 participants with major depressive disorder. And separate research published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.

This week’s approval of the psychedelics decriminalization measure in Ferndale marks the fourth time a Michigan city has decriminalized natural psychedelic drugs. Ann Arbor became the third city nationwide to decriminalize psychedelics with the city council’s adoption of a resolution in September 2020. That was followed by a similar move in Detroit in November 2021, while Hazel Park approved a measure last year. After Monday’s vote in Ferndale, the national headquarters of Decrimalize Nature took to social media to mark the occasion.

“Congrats again to the @decrimferndale team for all of their hard work and effort to pass the resolution in support of entheogenic plant practices in Ferndale Michigan last night,” the group wrote on Instagram. “That’s 4 wins in Michigan so far! Let’s get some statewide decriminalization legislation on the table!!! Go team Nature!”

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NFL star quarterback Aaron Rodgers will be a featured speaker at a psychedelics conference to be held in Denver this summer, less than a year after Colorado voters decriminalized the therapeutic use of psilocybin mushrooms. Touted by the Multidisciplinary Association for Psychedelic Studies (MAPS) as the “largest psychedelic gathering in history,” the Psychedelic Science 2023 conference will take place in June at the Colorado Convention Center.

Last year, the Green Bay Packers star quarterback revealed that he had traveled to South America to try the psychedelic ayahuasca on more than one occasion. Rodgers said that the experience changed his mindset and had a positive effect on his mental health, crediting the drug with helping him subsequently be selected as the NFL’s most valuable player two seasons in a row. In December, he added that using ayahuasca and psilocybin mushrooms has helped him cope with a strong fear of death he has had since he was a teenager.

Rodgers has been very open about his use of psychedelics and has said he hopes that sharing his experience can help dispel the stigma attached to the powerful compounds. And in June, he will be one of more than 300 speakers to address the Psychedelic Science 2023 conference in Denver. Presented by MAPS, the gathering has been hailed by the psychedelics research and advocacy nonprofit organization as the “definitive event of the psychedelic renaissance.”

“Aaron Rodgers will be interviewed by Aubrey Marcus at Psychedelic Science 2023 about his experiences with Ayahuasca, which he’s previously spoken about on Aubrey’s podcast,” said MAPS founder and executive director Rick Doblin. “We’re delighted Aaron is open to sharing his views at what will become the world’s largest psychedelic conference ever.” 

Psychedelic drugs including LSD, psilocybin, and ayahuasca have received renewed interest from researchers for their potential to treat a wide range of mental health conditions including depression, anxiety, post-traumatic stress disorder, and substance misuse disorders. In November, Colorado voters took new steps in psychedelic policy reform with the passage of Proposition 122, a ballot measure to legalize the possession and therapeutic use of certain natural psychedelic drugs including psilocybin mushrooms, DMT, ibogaine and mescaline, for people age 21 and older. The measure also authorizes the establishment of “healing centers” where adults can obtain access to natural psychedelics for therapeutic purposes. The measure, which passed with more than 53% of the vote, is now in the process of being implemented by state officials.

Aaron Rodgers And Psychedelics

Last weekend during an appearance on the The Pat McAfee Show, Rodgers said that he would make a decision about retiring from professional football after he takes a four-day “darkness retreat” later this month. The 18-year NFL veteran said that the retreat will include “‘sensory deprivation isolation’ that will simulate the drug DMT with the potential for hallucinations,” according to a report from CBS Sports. 

“It’s an opportunity to do a little self-reflection in some isolation and after that, I feel like I’ll be a lot closer to that final, final decision,” Rodgers said on Tuesday. “I’ve had a number of friends who’ve done it and they had profound experiences.” 

In August, Rodgers revealed that he had traveled to South America to take ayahuasca before being selected as the league’s most valuable player in back-to-back seasons, saying the traditional psychedelic brew changed his thinking and significantly improved his mental health. Rodgers made the revelations about ayahuasca experiences during an appearance on the Aubrey Marcus Podcast, saying that the psychedelic drug helped him find self-love and mental wellness.

The Super Bowl champion quarterback said he made the trip to South America before winning the MVP award for the third and fourth time. Following the ayahuasca experience, he said, he “knew that [he] was never going to be the same.”

“For me, I didn’t do that and think ‘oh, I’m never playing football again,’” Rodgers said, as quoted by USA Today. “No, it gave me a deep and meaningful appreciation for life. My intention the first night going in was ‘I want to feel what pure love feels like.’ That was my intention. And I did. I really did. I had a magical experience with the sensation of feeling a hundred different hands on my body imparting a blessing of love and forgiveness for myself and gratitude for this life from what seemed to be my ancestors.”

The Psychedelic Science 2023 conference takes place at the Colorado Convention Center from June 19 through June 23. Other featured speakers include Doblin, groundbreaking researcher Robin Carhart-Harris, wellness guru Deepak Chopra, and Amanda Feilding, the executive director at the U.K.-based psychedelics advocacy organization the Beckley Foundation.

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Two bills were filed in Massachusetts to decriminalize psilocybin mushrooms, ayahuasca, mescaline, and ibogaine. The bills would end the prosecution of psychedelic substances in the Bay State.

The Boston Herald reports that companion bills were filed in the Massachusetts House and Senate. The House bill, “An Act relative to plant medicine,” or Bill HD.1450, was filed by Rep. Lindsay Sabadosa. The Senate bill, titled “An act relative to plant medicine,” Bill SD.949 was filed by Sen. Patricia Jehlen.

Adults ages 18 and older would not be prosecuted for personal amounts of psychedelics.

The bill would decriminalize “the possession, ingestion, obtaining, growing, giving away without financial gain to natural persons 18 years of age or older, and transportation of no more than two grams of psilocybin, psilocin, dimethyltryptamine, ibogaine, and mescaline.”

The bills would amend the state general law’s Section 50: Entheogenic Plants and Fungi.

The bill however does not allow for the sale of psychedelics: “‘Financial gain’ shall mean the receipt of money or other valuable consideration in exchange for the item being shared,” the bill adds.

“Mushrooms are life changing,” James Davis, co-founder of Bay Staters for Natural Medicine, said in a statement. “From depression to addiction to painful cluster headaches, they are a tool that people should use in a caring community.

“There’s no better way to promote intentional and mindful use than to decriminalize minor amounts for home growing and sharing without enabling commercial sale,” Davis added.

“Humans have used psychedelic plants and fungi, non-addictive by their nature, for spiritual relief for more than 13,000 years: from Northern Africa and the Americas—to Greece and the Middle East,” Bay Staters for Natural Medicine states on their website. “President Nixon banned these plants as Schedule One “drugs” through the Federal Controlled Substances Act without scientific basis to purposefully criminalize Black Americans and anti-war protesters. We work to reverse these policies and stop for-profit corporations from monopolizing the facilitation market to needlessly charge desperate people thousands of dollars.”

The statewide move comes after a handful of cities decriminalized psychedelics at the city level. Somerville, Cambridge, Northampton, and Easthampton, for instance, voted to decriminalize psychedelic mushrooms and other entheogenic plants.

The reasons to decriminalize are growing: The global market for psychedelic drugs including psilocybin, ketamine, and LSD is expected to grow to nearly $12 billion per year before 2030, according to data from a recent market analysis. In a report released last Thursday, Brandessence Market Research revealed that the psychedelic drug market is anticipated to reach a valuation of $11.82 billion by 2029, growing from an estimated $4.87 billion in 2022.

Psychedelic-assisted therapy is undergoing somewhat of a renaissance. Belief that psychedelics could help control the opioid epidemic is growing. A 2017 Johns Hopkins University School of Medicine study, involving 44,000 participants, found that psychedelic use was associated with a 40% reduced risk of opioid abuse. A more recent study that suggested an even stronger reduced risk—55%.

Meanwhile, Tryp Therapeutics signed a letter of intent earlier this month with Massachusetts General Hospital (MGH), the largest teaching hospital of Harvard Medical School, to fund and conduct a Phase 2a clinical trial. The team of researchers will be investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21 and older who are suffering from Irritable Bowel Syndrome (IBS).

More states are moving to loosen laws surrounding psychedelic use for therapeutic purposes. Colorado and Oregon decriminalized psilocybin mushrooms.

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