As it turns out, your marital status could affect the extent to which psychedelics can lower your stress levels. And it appears that single folk may experience the greatest benefit of psychedelics. 

An analysis of data from the National Survey of Drug Use and Health revealed that individuals who had used psychedelics at least once in their lives, in general, had lower levels of psychological distress, according to research PLOS ONE. This association was most pronounced among people who were single and significantly weaker among those who were married, widowed, or divorced, PsyPost reports. 

There’s already loads of research that clearly establishes a positive correlation between psychedelics and mental health. The Department of Veteran Affairs is funding research into psilocybin and MDMA to treat PTSD and depression. The FDA recently recognized LSD’s potential to treat anxiety. And there’s a study suggesting that DMT may be an effective treatment for depression.

The research into the martial status and tripping looked at classical psychedelics like LSD, psilocybin, mescaline, and DMT, in addition to MDMA. 

The study’s author, Sean M. Viña, sought to explore the relationship between psychedelic use, marital status, household size, and psychological distress. He hypothesized that married individuals who have used psychedelics might experience reduced distress and that those in larger households would face increased distress. He also suspected that the beneficial effects of psychedelics on distress would be least pronounced among people with large households.  

Viña analyzed data from the National Survey of Drug Use and Health, which is an annual survey conducted across all 50 U.S. states and the District of Columbia. This survey seeks to measure the pervasiveness of substance use and mental health issues in the United States. 

This analysis looked at data on people’s distress levels over the past month using the Kessler Psychological Distress Scale. The Kessler Psychological Distress Scale (K10) is a straightforward tool for measuring psychological distress. It consists of 10 questions about emotional states, each with five possible responses. The K10 can be used as an easy screening method to figure out one’s levels of distress (you can try it here). 

It also considered whether participants had ever used classic psychedelics like DMT, ayahuasca, psilocybin, LSD, mescaline, peyote, or MDMA. It also included information regarding participants’ marital status, household size, and other demographic details.

While single people won in some ways, and we’ll get to that, the results indicated that married individuals experienced lower levels of distress compared to single and divorced people. Married folks’ distress levels were actually comparable to widowed individuals. 

Interestingly, the divorced individuals had the highest levels of drug use, unrelated to the psychedelics, which included cannabis but also tobacco, cocaine, tranquilizers, inhalants, pain relievers, and heroin. They also were more likely to have started drinking at an earlier age. While some of that substance use could be in reaction to divorce, it also may indicate that, unsurprisingly, an unhealthy relationship with drugs could lead to relationship problems. 

Those who reported using classic psychedelics, in general, had generally less psychological distress. This was held true even after considering marital status and household size. But the connection between psychedelic use and reduced distress was strongest in single individuals. It was also significantly weaker in those who were married, widowed, or divorced. So, while being partnered or mourning a partner could lead to less stress in general, such folks may have a reduced benefit from taking psychedelics. 

Notably, and giving child-free people a reason to celebrate, those with the most stress had larger households. If a person using classic psychedelics was married, the connection between living in a large household and experiencing psychological distress was even stronger. 

“The results confirm the predictions that LCPU [lifetime classic psychedelic use] exacerbates the negative consequences of household size for the heads of households who are married, widowed, and divorced. The results also suggest that larger households are associated with harm regardless of marital status, but the negative consequences decrease for single psychedelic users as the household size increases,” Viña explained. 

Viña went on to conclude that: “Widowed psychedelic users may experience some benefits from living with more people, but these benefits decrease as the household size becomes too large. In contrast, among married or divorced psychedelic users, the distress caused by household size worsens as the family sizes increase. Finally, for widowed psychedelic users, there is a negative association between household size and distress, but this association decreases at a decreasing rate.”

So, while, if you’re windowed, it might not be a bad idea to move in with a friend, don’t move in with an entire family. 

“These results can be explained by the increasing responsibilities that heads of households face as their families grow, which are then exacerbated by psychedelic use. On the other hand, single individuals may experience a diffusion of responsibility as their family sizes increase,” Viña said. 

It’s important to remember that while studies like this are fascinating, we don’t always know if they’re demonstrating correlation or causation. In other words, while psychedelics could lead to less stress for single people, compared to overworked and exhausted moms and dads, on the other hand, it could just be that single people are more likely to have less stress and have a free weekend to spend tripping. 

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On May 17, Maryland Gov. Wes Moore signed two bills that will create a psychedelic task force, called the “Task Force on Responsible Use of Natural Psychedelic Substances,” which was established by the passage of House Bill 548 and Senate Bill 1009.

Effective starting on July 1, 2024, the two bills green light recruitment for the task force, which will consist of 17 members. Together they will research a variety of considerations for “natural psychedelic substances,” including psilocybin, psilocin, dimethyltryptamine (DMT), and mescaline (but not peyote).

The task force’s mission is to recommend law and policy changes in order to build a program that “enables broad, equitable, and affordable access to psychedelic substances.” Task force members will also assess the best research available to better understand public benefits and uses of “natural psychedelic substances,” as well as review potential risks, and examine the best courses of action to increase accessibility. 

Additionally, the task force is also required to study various barriers for healthcare practitioners and facilitators, such as insurance, licensing restrictions, zoning, advertising, as well as financial services.

Members of the task force will also need to review how to approach civil penalty punishments for “the planting, cultivating, purchasing, transporting, distributing, or possessing of or other engagement with natural psychedelic substances.” The bills also address the requirement of expunging Maryland residents who were convicted of nonviolent psychedelic-related crimes, as well as releasing those serving time in prison for such crimes.

The 17-member task force will include the following: a Senator representative, a House representative, the Secretary of Health (or Secretary’s designee), the Secretary of Disabilities (or a designee), the Secretary of Veterans Affairs (or a designee), the Director of the Maryland Cannabis Association (or a designee), a representative from either the University System of Maryland, Johns Hopkins University’s Center for Psychedelic and Consciousness Research, or Sheppard Pratt (a private, nonprofit healthcare provider), a representative from a Native American tribe with experience in religious and/or spiritual use of psychedelics, a behavioral health expert, a substance use disorder expert, a chronic pain treatment expert, a psychedelic-assisted psychotherapy expert, a psychedelic researcher, an expert regarding care in underserved communities, a drug policy reform expert, a law enforcement expert, a patient suffering from conditions in which psychedelics can help treat, and finally a physician who has experience with the “appropriate use” of psychedelic substances.

The task force will be required to combine their findings in a report and sent to Moore and the general assembly no later than July 31, 2025. However, the task force will remain operating until December 31, 2026.

HB-548 was introduced earlier this year in January, and passed in the House by March 13, with a final passing in the Senate by April 3, while SB-1009 followed suite with an introduction in February, followed by passage in the Senate on March 18 and House passage on April 2.

While SB-1009 was still being considered in the Senate, sponsor Sen. Brian Feldman explained that cannabis has received its fair share of studies, and now it’s time to focus on the benefits fo other psychedelics. “This is actually an area that’s been studied far more than cannabis, whether for behavioral health issues related to post traumatic stress disorder, addiction broader behavioral health, depression issues, addiction, chronic pain, just another tool in the toolbox when you’re dealing with a treatments,” Feldman said in March, according to a WYPR news report.

University of Baltimore, Maryland pharmaceutical studies professor, Andrew Coop, explained that there are numerous studies being conducted and show a lot of promise with psychedelic-assisted therapies. “There are 54 clinical trials currently going on in Maryland and again, with a safety profile, almost unheard of showing including no overdose, no withdrawal, no hangover and no addiction,” Coop said. “There are clinical trials funded by the National Institutes of Health. The Food and Drug Administration has designated psilocybin a breakthrough therapy. The Department of Defense is funding psychedelic research for veterans. This shows the support of the federal government and the safety profile.”

Maryland legalized medical cannabis in 2013, while adult-use cannabis was approved by voters in November 2022, and sales began in summer 2023. Approximately 100 medical cannabis dispensaries were permitted to sell adult-use cannabis products at launch, and during the first week of recreational sales the state collected $20 million.

The mainstream status of cannabis continues to grow, and it’s affecting more than just consumers. Maryland Law Enforcement officer applicants are currently required to abstain from cannabis use for three years before being considered, but in January Montgomery County Police Chief Marcus Jones stood up against that rule. “I think in today’s environment, where we are with the legalization of cannabis, that has now restricted law enforcement agencies, particularly larger agencies, across the state,” said Jones.
In the meantime, Marylanders are already learning about the benefits of psychedelic-assisted therapy firsthand. Businesses such as Inner Path Wellness, based in Baltimore, Maryland, are offering an outlet to experiment with psychedelics as a treatment. Patient Tim Hamilton provided an oral testimony to the General Assembly on March 14 about the efficacy of such treatments. “They saved my life and it’s made me a better husband, a better father, and a better person,” Hamilton said. “It can help millions of people.”

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Massachusetts legislators held a joint legislative committee hearing last week to consider an initiative to legalize the therapeutic use of natural psychedelics. At the hearing, lawmakers heard from both supporters and opponents of the proposal, which can be approved by the legislature or referred to voters to decide the issue this November.

The proposed ballot measure is supported by Massachusetts for Mental Health Options (MMHO). The group is affiliated with New Approach, a political action committee that supported successful bids to legalize psychedelics in Oregon and Colorado. If passed, the proposed ballot measure would legalize “naturally occurring” psychedelics such as psilocybin mushrooms, peyote (mescaline), and ibogaine for consumption in “therapeutic settings through a regulated and taxed system.”

MMHO has already submitted nearly 100,000 signatures on petitions to support the ballot measure, sending it to the state legislature for consideration. If lawmakers do not approve the measure by May 1, supporters will be given until July 3 to collect an additional 12,429 valid signatures. If the signature drive is successful, the initiative will be placed on the ballot for the November general election.

Advocates Speak in Favor of Psychedelics Proposal

On March 26, the Massachusetts state legislature’s Special Joint Committee on Initiative Petitions held a hearing on the psychedelics therapy legalization ballot measure (Bill H.255). Emily Oneschuk, a military veteran and MMHO’s grassroots campaign director, told lawmakers about the mental health challenges she faced while serving in the U.S. Navy, including sexual assault, bullying and sexual harassment. After Oneschuk left the Navy, she took psilocybin at a retreat in Jamaica, where the psychedelic compound is legal.

“The whole of my psychedelic experience and the community associated with it has profoundly improved my quality of life,” Oneschuk told the committee, according to a report from the Commonwealth Beacon. “It brought me exactly where I needed to be to become a healthier and happier person.”

Dr. Franklin King, the director of training and education at the Mass General Center for the Neuroscience of Psychedelics and an instructor at Harvard Medical School, researches the effects of psychedelics. He told the joint committee that there is substantial evidence showing that psychedelics have therapeutic value for mental health conditions. He also noted that studies have repeatedly shown that the drugs can be taken by patients safely and effectively.

“The current legal status of psychedelics as dangerous drugs…is egregiously incorrect,” said King. “[For this] class of psychedelics, particularly psilocybin, the medical risks are extremely minimal and potential for abuse is close to zero. Millions of patients who need access to the benefits of psychedelics likely do not require the strict controls of the medical model.”

Franklin continued by saying that the current prohibition of psychedelics is hindering research and denying people with mental health challenges an alternative to less effective drugs.

“The criminalization of psychedelics not only impedes scientific progress, but also denies individuals access to potentially life changing treatments,” King told lawmakers, according to a report from New England Public Media. “We must adopt a more rational approach, one that prioritizes evidence based policies over outdated stigmas and prohibitions.”

Massachusetts Psychiatrists Urge Caution

Not everyone at the hearing, however, was there to support the psychedelics therapy legalization proposal. Dr. Jerrold Rosenbaum, a psychiatrist at Massachusetts General Hospital, told lawmakers “We really don’t know what are the potential harms.”

Rosenbaum agreed with testimony from supporters about the potential benefits of psychedelics. But he also warned about the potential for people to misuse the powerful compounds.

“Psychedelics are not something people can use casually at full doses,” he said in testimony cited by Boston’s NBC News affiliate. “They really require being in a safe place with support for most people.”

The psychiatrist acknowledged similarities between the campaign to legalize marijuana, which succeeded in Massachusetts in 2016 with the passage of a ballot measure that received more than 63% of the vote. But he added that reforming policy governing psychedelic drugs should be approached with more caution.

“The psychedelics are used very intermittently, not continually the way marijuana can be. The effects are much more profound,” he said.

Dr. Nassir Ghaemi, a professor of psychiatry at Tufts Medical Center and the incoming president of the Massachusetts Psychiatric Society, also testified before the committee. He told lawmakers that there has not been enough research on the public health outcomes of legalizing psychedelics.

Democratic Senator Paul Feeney, a member of the legislative committee, noted that psychedelics are already being used recreationally by many people and asked Ghaemi if it would be better if lawmakers adopted regulations governing their use. The witness agreed, but only if the ballot measure is approved in November. Otherwise, he said the legislature should wait until additional research has been completed.

The joint committee will now review the testimony given at the hearing before voting on whether to advance the proposal.

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The Multidisciplinary Association for Psychedelic Studies (MAPS), a 34-year-old nonprofit research and educational organization “that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana,” announced in a press release on Monday that it “has partnered with the City and County of Denver to provide comprehensive training on psychedelic crisis assessment and intervention to the city’s first responders.” 

The Psychedelic Crisis Assessment and Intervention training was “commissioned by the Denver Psilocybin Mushroom Policy Review Panel (DPMPRP), a first-of-its-kind panel that was formed after the passage of Ordinance 301 in May 2019, which effectively decriminalized the personal use and possession of psilocybin mushrooms in Denver,” MAPS said in a statement. 

Per the press release, the training will cover topics including: “The history, usage, psychological and physiological response, and potential adverse effects of psilocybin ingestion”; “The legal considerations and implications of decriminalization and the role of first responders”; “The standards and protocols for effective psilocybin or psychedelic-related crisis response planning, training, and deployment”; and “The best practices and techniques for assessing, de-escalating, and managing psychedelic crises.”

According to the local publication Westworld,  the training program “became even more important in 2022, when Colorado became the second state (after Oregon) to legalize medical psilocybin use and the first state to decriminalize specific psychedelics, including psilocybin, DMT, ibogaine and mescaline.”

“Created as part of the 2019 voter initiative decriminalizing psilocybin, the Denver Psilocybin Mushroom Policy Review Panel took a brief hiatus in 2023 after Prop 122 passed,” Westworld reported this week. “But the panel is meeting again and is expected to take a leading position in Denver’s approach to its medical psilocybin rules.”

After Prop 122 passed in 2022, Colorado Gov. Jared Polis, a Democrat, signed the measure into law last year. The law directs “the department of revenue [to create] the natural medicine division for the purpose of regulating and licensing the cultivation, manufacturing, testing, storage, distribution, transport, transfer, and dispensation of natural medicine or natural medicine product between natural medicine licensees.”

The measure requires the natural medicine division to: “Regulate natural medicine, natural medicine product, and natural medicine businesses, including healing centers, cultivators, manufacturers, and testers, and issue licenses for such businesses; Promulgate rules necessary for the regulation of natural medicine, natural medicine product, and natural medicine businesses; and Perform duties necessary for the regulation of natural medicine, natural medicine product, and natural medicine businesses, including investigatory and disciplinary authority.”

Kevin Matthews, former President of the Denver Psilocybin Mushroom Policy Review Panel, celebrated the launch of the training program.

“I’m proud of my hometown for stepping into a national leadership role with this training. It represents a giant leap forward for public health and safety with psilocybin and natural medicines in Denver and is a perfect example of what cities can do to better integrate emerging psychedelic policies into their existing infrastructures. I’m looking forward to the city continuing its collaboration with MAPS to monitor outcomes and educate Denver residents on this exciting new issue,” Matthews said in a statement.

Sara Gael, a former MAPS Harm Reduction Officer, said the group is “honored and excited to collaborate with the City and County of Denver to provide this groundbreaking training program on psychedelic crisis assessment and intervention.”

“We believe that this program will equip first responders with the necessary knowledge and skills to handle psilocybin and psychedelic related crises in a safe and compassionate manner and ultimately improve the health and well-being of the community. This program is also a testament to the progressive and visionary leadership of Denver, which has taken a bold step to decriminalize psilocybin and create a model for other cities to follow,” Gael said.

MAPS said in the press release on Monday that its “training aims to enhance the knowledge, attitudes, and skills of first responders to quickly recognize and effectively respond to emotional and behavioral crisis incidents involving psilocybin and other psychedelics.” The group also said that the “Denver Harm Reduction training initiative has been well received by the City of Denver leadership, who recognize the importance and value of providing first responders with the necessary tools and skills to handle psychedelic-related crises in a safe and compassionate manner.”

“The program also seeks to enhance responder safety and reduce risk and liability in situations where individuals are experiencing a psychedelic-induced crisis,” the group explained. “After three years, a team of over 20 MAPS and subcontracted professionals with backgrounds in law, medicine, psychiatry, mental health, neuropsychopharmacology, law enforcement, crisis response, quality improvement, and education developed the curriculum. The final training is customized for law enforcement, mental health, and emergency medical service personnel and will be delivered through asynchronous videos and corresponding assessments.”

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Native American and preservationist advocates are sounding the alarm about an imminent “peyote crisis.” The crisis started decades ago, but recently has been amplified by pharmaceutical interests in mescaline, the psychoactive compound the cactus is known for.

The mescaline-rich spineless cactus, Lophophora williamsii, has been used in sacred rituals for over 5,000 years by American indigenous cultures, but through careless harvesting by recreational users, or worse, mass produced pharmaceutical companies, all of that could soon be lost. In the U.S. the cactus only grows wild in Texas—where it’s been declared an endangered species—as well as Chihuahua, Coahuila, Nuevo León, and Tamaulipas in northern Mexico.

The cactus is currently being monetized for either pharmaceutical or recreational use, and indigenous groups like the Native American Church (NAC) are concerned that the sacred plant is being exploited. In the December 1977 issue of High Times, journalist J. F. Burke wrote about his journey with peyote that started in 1957, one of the first in-depth articles about the plant, just as the federal government was making exemptions for a short list of Native Americans. Since then, a lot of hippies, psychonauts, and wannabe shamans have scoured the earth looking for ways to find it.

The American Indian Religious Freedom Act of 1978 (42 U.S.C. § 1996.) protects the rights of Native Americans to exercise their traditional religions–including psychedelic sacraments. On Dec. 22, 1981, the Department of Justice reiterated the DEA’s peyote exemption for the NAC, but only bona fide members of the church are included. Only allowing that single church was challenged in 1994 under Peyote Way Church of God, Inc. v. Thornburgh and Congress amended the American Indian Religious Freedom Act to legalize peyote use by all members of Native American tribes.

Vice reported last September Canada-based Lophos Pharma, a publicly-traded company, started to produce the psychoactive cactus for pharmaceutical, not spiritual purposes. Lophos runs a 10,000-square foot facility in Napanee, Ontario. Mescaline itself is illegal under Schedule III of the Canadian drug act, peyote is permitted, so long as the mescaline isn’t extracted from it. But some say even medical purposes are not the way the cactus should be consumed, as it’s considered sacred.

Peyote Advocates Push Back

Colorado-based journalist Annette McGivney has recently been advocating for the preservation of peyote and the sacred ceremonies that surround it.

McGivney told KJZZ that she visited with the two camps of people: “One is, you know, the plant medicine activists and then the pharmaceutical entrepreneurs, so the plant medicine activists had two different responses,” she said. “One was they were totally oblivious to the Native American worldview and why it would not be OK with them for someone to just grow a peyote cactus in their home greenhouse. They had no idea or they were coming up with their own justification saying, ‘Well, it’s not interfering with Native American spirituality because we’re growing the cactus ourselves. So we’re not taking it away from its natural habitat.’ And they kind of come up with their own justification, ignoring what Native Americans were actually saying, that that was a problem.”

Companies like Lophos Pharma, which is growing peyote legally in Canada, as well as researchers in the U.S. are also a threat to the sanctity Native American religious ceremonies.

“And then the pharmaceutical industry has their own justifications about why they’re not infringing on Native American spirituality, which is they’re using synthetic mescaline. So they’re creating chemical compounds in a lab that clone the cactus, the psychoactive substance. So they’re saying that’s OK because we’re not actually using the cactus, but for Native Americans and their worldview around interconnectedness and respecting the sovereignty of plants as well as humans. They say it’s not OK to clone our sacred cactus.”

Last month McGivney also wrote for The Guardian about the same issue. In Window Rock, Arizona, members of the Navajo Nation, called the Diné partake of azeé (peyote). “How would Christians feel if Jesus Christ was cloned?” Justin Jones, a Diné peyote practitioner and legal counsel for the NAC asked The Guardian. “And while the real Jesus is protected, people could do whatever they wanted to the clone.”

The NAC is the same church Burke explored in the 1950’s. Other Native American healers and shamans echoed the same response, saying that cloning or mass-producing peyote is fundamentally wrong from their context.

“I’m all for healing,” said Cora Maxx-Phillips, a social worker, member of the Navajo Nation human rights commission and board member of the Council of Peyote Way of Life Coalition, a Navajo Nation grassroots group. “But don’t do it at the expense of our people, who are trying to survive the multigenerational trauma inflicted upon us. Please, leave us alone.”

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The Drug Enforcement Agency (DEA) posted a notice on the Federal Register on Jan. 3, which includes the most recent breakdown of Schedule I Substances in its 2024 aggregate production quotas (APQ), as well as a wide variety of public comments and DEA responses.

According to a Federal Register article published in November 2023, delta-9 THC (referred to as “d-9-THC” on the list) included a proposed amount of 900,610 grams for 2024. Now, the 2024 APQ includes a delta-9 THC of 1,523,040 grams. In comparison to last year, the established quota for delta-9 THC in 2023 was listed at 384,460 grams, while the revised quota amount was increased to 628,460.

According to the same November 2023 Federal Register article, the proposed amount of “all other tetrahydrocannabinol” was listed at 790,010 grams. Now, the 2024 APQ lists the THC quota at 1,166,130 grams. In an October 2023 APQ adjustments report, the DEA listed general THC at 15,000 for 2023 established quotas, and 350,000 for proposed revised 2023 quotas.

The DEA also included a request for 20,000 grams of psilocybin (which was established in October at 8,000 grams but increased to 15,000 grams). DMT (5-Methoxy-N,N-dimethyltryptamine) was also listed at 3,000 grams in October and November 2023, but was updated to reflect an increase to 11,000 grams in the most recent January 2024 report.

Production goals for other substances such as marijuana (6,675,000 grams), marijuana extract (1,000,000 grams), psilocin (24,000 grams), ibogaine (150 grams), MDMA (12,000 grams), and mescaline (1,200 grams) saw no changes between November 2023 and now. Over time, the DEA has gradually increased the quota for many of these substances due to increased interest.

In the November report, the DEA explained its expectation for this trend. “There has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” the DEA wrote. “DEA has received and subsequently approved new registration applications for Schedule I researchers and new applications for registration from manufacturers to grow, synthesize, extract, and prepare dosage forms containing specific Schedule I hallucinogenic substances for research and clinical trial purposes.”

The public comment portion of the report was compiled of 4,699 public comments “from DEA registrants, people with chronic pain, patients with attention deficit/hyperactivity disorder (ADHD), pain advocacy associations, U.S. professional associations, U.S. nurses, the Royal Australian and New Zealand College of Psychiatrists, the Australian ADHD Professionals Association, the ADHD Foundation Australia, and others.” Those comments varied in topic, from opioid drug shortages, stimulant drug use in both the U.S. and Australia, and more.

In one of the comments, three manufacturers requested that the proposed APQ for “dexmethylphenidate (for conversion), lisdexamfetamine, and psilocybin be established at sufficient levels for manufacturers to meet medical and scientific needs.” Additionally, the DEA also received quota applications “for 4-Anilino-N-phenethyl-4piperidine (4-ANPP), all other tetrahydrocannabinol, delta-9- tetrahydrocannabinol, dimethyltryptamine, fentanyl and pentobarbital.”

Another public comment referred to the religious use of Schedule I substances (specifically “psilocin, psilocybin, mescaline, ibogaine, lysergic acid diethylamide (LSD), 2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2CI), dimethyltryptamine (DMT), 5-methoxy-NN dimethyltryptamine (5-MeO-DMT)”). In one case, the Native American Church requested that the APQ for mescaline (aka peyote) be increased for their use, and allow its planting in the wild due to shortages. The commenter claimed that the DEA “has disregarded their legal religious use of psychedelics as a factor when setting the production quotas of these substances,” and requested a hearing if the agency does not grant their requests. The DEA’s response didn’t address the statement, and only wrote that the DEA has worked with indigenous communities in the past.

Another request included listing the fruiting bodies that contain psilocybin and psilocin, as well as “peyote buttons containing mescaline,” in the quotas, rather than just the pure chemicals. However, the DEA responded by stating that the APQ listings are based on the Controlled Substances Act and it will continue to label them in accordance with the act. Also technically, peyote is categorized separately from mescaline.

The DEA recently issued a warning to the state of Georgia for independent pharmacies selling low-THC cannabis oil products. “All DEA registrants, including DEA-registered pharmacies, are required to abide by all relevant federal laws and regulations,” a letter sent to pharmacies in December 2023 stated. “A DEA-registered pharmacy may only dispense controlled substances in Schedules II-V of the Controlled Substances Act. Neither marijuana nor THC can lawfully be possessed, handled, or dispensed by any DEA-registered pharmacy.”

Georgia pharmacies officially began selling low-THC cannabis oil in October 2023. At the time, only three pharmacies received a license to sell cannabis with less than 5% THC, although there are more than 400 independent pharmacies that could be a part of the program throughout the state.

With substances like fentanyl rising as one of the most common sources of overdose death last year, it’s imperative that research on the benefits of cannabis, psilocybin, DMT, continue to progress.

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An effort to decriminalize psychedelic substances was nixed after California’s governor vetoed the bill on grounds that the bill is missing dosing guidelines and other critical inclusions that he says would have made it safer.

To the dismay of psychedelic advocates across the state, California Gov. Gavin Newsom vetoed Senate Bill 58 on Oct 7, a bill that aimed to decriminalize the possession and personal use of several hallucinogens, including psilocybin mushrooms. Newsom announced that he vetoed SB-58 and 43 other bills in his announcement. 

The bill would have allowed those 21 and older to possess psilocybin, and other psychedelic substances including dimethyltryptamine (DMT) and mescaline. The bill would have taken effect in 2025, and would have required the California Health and Human Services Agency to study and to make recommendations to lawmakers on the therapeutic use of psychedelic substances.

Newsom explained that he would approve a bill if it had more rigid guidelines. “California should immediately begin work to set up regulated treatment guidelines—replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses,” Newsom’s statement said. “Unfortunately, this bill would decriminalize possession prior to these guidelines going into place, and I cannot sign it.”

State Sen. Scott Wiener, who authored the bill, said that vetoing the bill is a step backwards for California, maintaining that people caught with psychedelics will continue to be treated as criminals.

“This is a setback for the huge number of Californians—including combat veterans and first responders—who are safely using and benefiting from these non-addictive substances and who will now continue to be classified as criminals under California law,” Wiener said in a statement Saturday. “The evidence is beyond dispute that criminalizing access to these substances only serves to make people less safe and reduce access to help.”

“Gov Newsom vetoed SB 58, our bill to decriminalize mushrooms & other naturally occurring psychedelics,” Wiener tweeted. “So for now, folks who benefit from these non-addictive substances remain classified as criminals under CA law. Our fight is not over. We’ll be back with legislation next year.

It’s not the lawmaker’s first attempt at decriminalizing psychedelics in California. Wiener unsuccessfully attempted to approve a broader bill last year that would have also decriminalized the use and possession of LSD and MDMA.

Last month, the Governor was handed 17 bills related to cannabis and psychedelics, including SB-58. The bills include a wide variety of proposals, which Newsom must either sign, veto, or refuse to sign and allow them to be approved without his signature.

In the past, Newsom has expressed support for cannabis and psychedelics, but has vetoed efforts that he deemed rushed or ill-prepared.

California Legislature Approved the Bill

This bill was approved by the California Legislature and passed on to the Gov. Gavin Newsom on Sept. 13. It would legalize possession, cultivation, and transportation of substances such as psilocybin, psilocyn, DMT, and mescaline. The bill was led by Sen. Scott Wiener, who believes that it will help many patients, especially military veterans, within the state. 

“California’s veterans, first responders, and others struggling with PTSD, depression, and addiction deserve access to these promising plant medicines,” said Wiener when the bill passed in the Assembly. “SB-58 has prudent safeguards in place after we incorporated feedback from three years of deep engagement with a broad array of stakeholders. We know these substances are not addictive, and they show tremendous promise in treating many of the most intractable conditions driving our nation’s mental health crisis. It’s time to stop criminalizing people who use psychedelics for healing or personal well-being.”

Other states are moving forward quickly with bills to loosen up laws surrounding psychedelics. In 2020, voters in Oregon approved a bill that decriminalized small amounts of psychedelics. The state was the first to approve the supervised use of psilocybin in therapeutic settings. Voters in Colorado approved a ballot measure last year to decriminalize psilocybin mushrooms and to create state-regulated centers.

Things are moving fast: The U.S. Federal Drug Administration (FDA) designated psilocybin as a “breakthrough therapy” for treatment-resistant depression in 2019. In addition, recently published draft guidance on using psychedelics in clinical trials is pushing the movement forward.

Moving forward, lawmakers can override a governor’s veto with a two-thirds vote, but this has not been achieved in decades.

There are already more ways California voters could decriminalize psychedelics in California. Advocates are working hard to put two initiatives on the November 2024 ballot to expand psychedelic use. One bill would legalize the use and sale of mushrooms for adults ages 21 and older. The other bill would allocate $5 billion in state funding to establish a state agency tasked with researching psychedelic-assisted therapy.

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By J. F. Burke

Most of my life it’s been boo, booze and blow. I didn’t get into trips until I was 42, in 1957, when a friend of mine in Santa Fe introduced me to peyote. A Taos Indian had given a dozen peyote buttons to each of several persons in Santa Fe’s art colony. One of them a serigrapher who did realistic still lifes of mushrooms had been waiting for me to arrive and trip with him.

I knew very little about peyote at that time, but I did know enough to be aware of the problem of getting it past our palates, so I pulverized the dried buttons in a Waring blender and tamped the powder into gelatin capsules. Otherwise our soft palates might have reflexively ejected the peyote, which I’d been told was incredibly bitter. We washed the caps down with cold mountain well water.

My friend’s trip must have been very strange, for he spent the first eight hours wrapped in a Navaho blanket, curled up like a chrysalis in a cocoon and chanting in a language that sounded Indian to me. After eight hours he emerged from his cocoon smiling, looking beatific and saying nothing. Very mysterious.

Afterwards, when I asked him what language he’d been chanting, he said English. I objected that it didn’t sound remotely like English but very much like some Indian tongue. He said that was just my own mental confusion, a peyote hallucination. When I asked him what he’d been chanting about, he said he’d been chanting “in praise of everything,” as he put it. Just what an Indian shaman might do, I commented. He ridiculed the thought. But if he really believed he’d been chanting English, he was out of his tree. English it was not.

As for my own trip, I spent the first four hours laughing, just laughing, for everything was laughable. It seemed to me that laughter was the truest response to the world. Apparently I’d needed a good laugh for a long time.

The next time Mescalito came to me, I was with my wife Rosa. We ate peyote every day for 15 months. Mescalito stayed with us all that time. Sometimes I feel he never left.

Rosa and I sent to Smith’s Cacti Ranch in Laredo, Texas, for peyote, which was legal then and was being sold in the East Village for 25 cents a button. We got it by mail order at $10 per 100 buttons plus $3 postage. You received your shipment via parcel post with a U.S. Department of Agriculture stamp on the carton attesting to the purity of the contents. This was back in 1961—the good old days!

Our first shipment arrived on a Friday. A few of the buttons had rotten spots from being locked up in the mailing carton for several days. These were big, fresh, green, juicy buttons. We cut out the bad spots. Then we set the hundred buttons out around the apartment, wherever there was a horizontal surface. They were everywhere. They seemed to have presence, as we say in theater. They were fleshlike to the touch, and they looked lovely with their elegant little silvery tufts. We could smell them, too, an earthy smell, quite delicate. They looked like big, round living emeralds. Or perhaps imperial jade.

I cut a slice off one, and we tasted it. Words have not been coined for such unbelievable bitterness. So we had a problem. How to eat this little green god? You can’t pulverize the fresh, juicy buttons and cap them as with the dried ones. We knew that people had tried to minimize the taste by brewing infusions, boiling porridge, making milk shakes. We decided that somehow we’d meet the problem head-on. So we slept on it.

While we slept, Mescalito was everywhere in the room, 100 of him. Saturday morning we woke up knowing how to handle the eating problem. We removed the tiny silvery tufts, washed the buttons in cold water, dried them gently with soft towels and then chopped up a few of the biggest, fattest, juiciest. We minced them. We also ground some dark Brazilian beans and made a pot of strong coffee laced with honey.

Still, it’s no easy task chewing the bitter green mass prior to swallowing it. You chew like a rabbit, keeping it in the front of your mouth, well away from the soft palate. Then, when it’s ready to be swallowed, you put the cup of coffee to your lips, swallow the peyote and follow it immediately with the coffee so that you’re washing the peyote past the esophagus before the soft palate can react. Once it’s past the esophagus you’re home free, except perhaps for a queasy stomach.

Some people experience nausea, and some even throw up, but it’s no big thing, for the peyote comes up much easier than it goes down, and it doesn’t have to stay in the stomach long for the active principle (mescaline) to enter the bloodstream. I’ve never had more than a very slight queasiness, and I’ve never thrown up. The queasy feeling doesn’t last long. Anyway, I enjoy the initial toxic reactions, particularly the muscle spasms. Orgasmic.

Now, one of the most significant things that Mescalito taught us about ourselves during our 15 months’ regimen is that peyote itself does not taste bitter. This is not a paradox. If you continue eating peyote every day, and long enough, the bitterness decreases. Eventually it will go away altogether. But the peyote itself is a constant factor, so it can’t be the cactus that changes. If it was bitter, it will still be bitter. Ergo, the peyote wasn’t bitter; the peyote eater’s taste was.

Certainly peyote clears and heightens the senses, all of them, so that we see, hear, taste, feel and smell differently, more intensely, deeply, clearly. It shouldn’t be surprising, then, that the taste of the taster changes. To put it another way, Mescalito is not only a teacher. The little god is also a profound physician. For some of us, peyote can be a psychic purgative.

We’d done our homework, so we knew what was then generally known about Lophophora williamsii. Since the main active principle is the alkaloid mescaline, the dosage of which varies around 400 milligrams, depending on one’s body weight, we assumed the peyote dosage should be measured likewise. Being a small woman, Rosa ate only three of the buttons, big ones. I’m 5’11” and then weighed 175 pounds, so I ate nine. Then we smoked some reefer and waited.

In about 20 minutes, I became restless, so instead of waiting for the reaction I went out and spaded the new garden plot. We’d just moved into the apartment and had yet to start our first seeds. The arable part of our garden measured some 30 by 40 feet, but it took me only half an hour to turn the earth and weed it. When I was done, I was sweating so heavily I looked like I’d been standing in a cloudburst. And I smelled like a cab horse. I undressed and went into the shower. Rosa joined me.

When we came out, still naked and dripping wet, we saw with wonder the paintings on our walls glowing as if alive. The walls themselves seemed to breathe. The big tree in our garden was moving not only its limbs, branches and leaves, but its very bark seemed to undulate. Everything was in pulsating motion.

I felt like singing, so I picked up my mandola and began to tune it. And here Mescalito rid me of a very annoying problem. I’d always loved to play stringed instruments and sing, but I had no tone control. I was utterly incapable of tuning the instrument accurately, and I couldn’t sing on pitch. I could hear the awful sounds I made, all right, but I couldn’t help it. My habit was to play and sing only when I was alone, but of course from time to time someone would have the misfortune to hear me.

On this peyote morning I tuned the mandola accurately and sang truly for the first time in my life. I felt like a fledgling in first flight. Free! Rosa and I often sang duets after that, when we were tripping. She taught me her Portuguese songs, fados, and I taught her Mexican and Spanish songs.

On that first peyote Saturday we were so charged that despite our long shower we had to take our energy to bed, and there we merged, entwined like Aztec stone carvings into a single complex form, interpenetrating, so that we could not tell who was inside whom. For a time we seemed to be lying atop a great pyramid in Mexico, alone together under a high blue sky, our kaleidoscopic orgasms surging, ever changing, reaching into all parts of our bodies, filling us with brightness and sheer ecstasy.

It must have been early afternoon when our apartment and unplanted garden were suddenly transformed into a Mexican hacienda somewhere in Chihuahua, and we seemed to see golden chamiso bushes and a tall yucca with a yucca moth hovering among the pearly flowers. We could smell the desert and hear lizards and small birds chirping. The fantasy—or as Carlos Castaneda later would say, this other reality—was very substantial even though we knew we were in Manhattan and there were no chamisos or yuccas, much less yucca moths, in our backyard. And we saw much more, which later I set down in a poem.

Yucca welcomes her lover under the moon.

He hovers like pale kisses, fluttering. Silkworm weaves his mandarin cocoon.

Cat schemes by a groundhole, muttering.

Owl waits and watches, hooting mirth.

Hummingbird drinks nectar from the rose.

She opens her secret petals ardently.

Roots strongly embrace the warm and willing earth.

And all things love to be sweetly bound, not free.

Ask the yucca’s personal moth, who knows.

Of thoughts like these our waking dreams are spun:

We would be as flowers that follow the sun—

Oh, never count the hours!—As the river grows

from streams and flows to the sea, so would we be.

After our first four hours’ rush, we had four hours of very high euphoria and fresh perceptions and then four hours of gently settling back, except that we didn’t get all the way back to where we’d started. We never did. Not quite.

We went to sleep high that night, slept beautifully and woke beautifully in the dawn, ready for love and a good breakfast. We were in for a surprise. When we’d prepared our usual eggs and toast, we didn’t want the eggs. Couldn’t eat them. Though very hungry, we were nauseated by the smell of cooked eggs. What we really wanted, and what we ate with gusto, was fresh fruit, bread, cheese and coffee. We didn’t know it yet, but Mescalito was already turning us into vegetarians, curing us of smoking tobacco and giving us a distaste for alcohol. The little god also got us into reading yogic literature, but that came with time.

We ate peyote again at sunset that day, which was a Sunday, and made a night trip. Again we took it to bed and got deep into our inner spaces. Clinging together, entwined, floating freely in space that was both microcosm and macrocosm, we saw atoms and molecules as miniature solar systems and galaxies, and we saw the visible universe as a crystal of star systems, which of course we recognized as the mescaline molecule. When we’d reached the thumping conclusion that the universe was a colossal crystal of mescaline, we understood. Mescalito has a cosmic sense of humor. To put it philosophically, the little god was demonstrating oneness.

The following day was Monday, but I didn’t go to the office. I’d decided during the night to try working behind peyote, since we’d found it to be such a powerful energizer. However, discretion being the better part of valor, I thought I’d better run the experiment at home. I could imagine some pretty funny scenes if I should start tripping at Westpark Publications. I wasn’t sure what a working dosage should be, but that it was possible to work on peyote I had no doubt, for a seafaring friend of mine had once dealt craps in Las Vegas while on peyote, and he had to keep a lot of action sorted out in his mind. He said peyote helped him do it fast and accurately. Three buttons, he said.

Huxley had written in The Doors of Perception, “Mescaline… gives access to contemplation—but to a contemplation that is incompatible with action and even with the will to action, the very thought of action.” Well, I didn’t think so. That was his trip. Not my seafaring crap dealer’s. Certainly the Huichol, the Tarahumara and other nations get into a lot of action when they’re tripping on peyote. They sing, dance, run up and down mountains.

As it turned out, I could as well have made the test at the office. I ate three buttons of medium size and waited an hour, then got into some manuscripts. It wasn’t a trip, on this smaller dosage, but I still felt enormously energized. I was, however, allowing myself to get too deep into the work, deeper than it called for. This, I could see, was something I’d have to watch if I wanted to work behind peyote.

I’ve worked behind grass for over 20 years, and I recall that at first I had to learn how to handle, how to concentrate behind smoke. Well, concentrating behind peyote is a bit harder to learn, but once you’ve got it, you can concentrate better than before. Deeper, more focused. Or centered. By noon the work was done.

The next day was Tuesday, and I went to the office after breakfasting on three peyote buttons, medium size. A number of my associates commented on my appearance and mood. “You’re looking great. Been smoking something?” That sort of thing. The day went fast and I got a mountain of work done. When I got home I found that Rosa had spent the whole day, instead of her usual two or three hours, writing in her journal.

And that’s the way it went for the next 15 months: love first thing in the morning, peyote for breakfast, good work all day, together again for dinner and a quiet evening talking, then bedtime and more love and sleep.

Weekends we’d sometimes take larger doses and see how far out (or in) we could trip. And from time to time we’d abstain for a day or two, to check up. At first we found that peyote’s salutary effects seemed to last only two or three days before we developed a yen. Nothing heavy. Just a yen. But as time went by we also noticed that we needed less to get off, until at the end of 15 months I was taking a single large button in the morning, and Rosa a smaller one. Of course, we sometimes replenished ourselves during the afternoon with another button.

There was no comedown at the end of the day, no crash, only a pleasantly tired feeling and a readiness to rest. If we wanted more energy then, we simply ate another button. Why no crash? Where did all the energy come from? Not from peyote. The cactus acts like a catalyst. The energy comes from the peyote eater. We have a much greater energy potential than we’re ordinarily aware of. It’s like the mind’s potential, which, as is well known, we barely tap. Well, peyote taps it but doesn’t exhaust it. There’s always more. On occasion, say a weekend, we’d trip on and on, without sleep, eating a button or two from time to time, for 36 or 48 hours. How long we could have gone, I have no idea, but there seemed to be no reason to try and set a record on that count. We’d already set one by the end of our first month on peyote.

I soon began taking my lunch to work. I kept a basket of bread and cheese, fresh fruit and raw vegetables on my desk, and one of the fruits (vegetables) was always a large peyote button, in case I felt like recharging during the afternoon.

The first of my fellow workers to ask about the strange green fruit in the basket was Bob Shea, one of the swingier editors at Westpark. The dialogue went something like this:

“Is that some kind of tropical fruit? It looks like a cactus.”

“It’s peyote.”

“Heard of it. Mind if I taste it?”

“Please do.”

He took a tiny bite, very tiny, and put the rest back in the basket. He gave me an odd look and went to his office across the hall. In half a minute I heard him spitting and making guttural noises.

He came back saying, “You mean you actually eat that stuff?”

“Every day.”

“You’re pulling my leg. I hope to God it doesn’t make me sick.”

To allay his anxiety I took a fair bite out of the big button that he’d nibbled. I chewed it well and carefully, up front between my front teeth, and swallowed it without coffee. Bob looked at me as if I’d gone mad.

He knows better now, of course, for since then he’s co-written a book called Illuminatus, which gives clearly recognizable evidence that he’s found a way into his own head.

Mescalito certainly smiled on Rosa and me, for all those 15 months. The end came when some professional prohibitionists in Washington, D.C., decided that peyote was Indian medicine, fit only for Indians, not for whites. The official decision was that it could be used only for religious ritual by bona fide members of the Native American Church.

Smith’s Cacti Ranch and other legitimate suppliers weren’t willing to bootleg the buttons, which cut down the supply to the vanishing point, so that was the end of our 15 months. From time to time some buttons would show up in New York, and they still do, very poor plants compared to what we were used to.

Those 15 months were one of our highest times, though not, I hasten to add, the very highest. That high came soon after, when we received our first little sugar cubes from a beautiful psychedelic artist in the East Village.

Read the full issue here.

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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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