Smashed Peaches

Drug Research Studies

Psychedelics and Mental Health Care — What Policymakers Need to Know – Niskanen Center

The past few years have seen a resurgent interest in the medical and therapeutic use of psychedelics. The results of peer-reviewed research on the use of psychedelics to treat veterans with post-traumatic stress disorder (PTSD) have graced the pages of prestigious scientific journals. In 2019, Denver decriminalized psilocybin mushrooms. And last summer, an amendment to ease restrictions on federal funding for Schedule 1 drugs almost passed the House of Representatives.

Many psychedelics are likely to become legal in the near future, either for medical use through approval from the Food and Drug Administration, or more broadly available for recreational use through state and local reforms. This overview explains how policymakers can encourage this promising area of research while ensuring the safe use of psychedelics within the American health care system.

Brief overview of current law

Shortly after the 20th century discovery of the psychoactive effects of psilocybin mushrooms and lysergic acid diethylamide (LSD), American government agencies and academics began to study their potential applications. In 1965, researchers discovered that LSD could potentially treat alcoholics resistant to conventional group therapy. Interest in LSD and psilocybin quickly spread beyond research facilities and into 1960s counterculture. There were highly respected scientists who used psychedelics, such as Francis Crick. Yet their most prominent champions were artists and authors, including Harvard’s controversial Timothy Leary and musical icons The Grateful Dead.

The haphazard use of psychedelics, especially among artists and their followers, provoked a severe political backlash from cultural conservatives, which was folded into Richard Nixon’s presidential campaign and the ‘war on drugs.’ In 1968, the Staggers-Dodd Bill outlawed possession of the most popular psychedelics, and this soon cascaded into the decision to classify psychedelics as Schedule 1 drugs under the Controlled Substances Act. Schedule 1 is the most restricted designation under federal law, and is reserved for chemicals that have “no acceptable medical use.”

The cultural and political backlash to psychedelics had an immediate chilling effect on the nascent and growing body of scientific research. From the 1970s to the early 1990s, there were few peer-reviewed published studies involving human subjects. Meanwhile, nations around the world followed America’s lead by criminalizing psychedelics and placing restrictions on academic research. To study psychedelics “ would be career suicide,” noted University of California, San Francisco Professor Andrew Penn. “The Controlled Substances Act made it so a lot of people in academia moved away from studying this.”

In the years since, there have been a few notable exceptions to the criminalization trend. In 2001, Portugal made the historic decision to decriminalize all drugs, and the Netherlands allowed psilocybin-containing truffles.

Perhaps the most significant reversal of this trend was instigated by the Multidisciplinary Association for Psychedelic Sciences (MAPS). In the early 1990s, MAPS received approval from the Food and Drug Administration (FDA) to initiate a series of clinical trials of MDMA-assisted psychotherapy (MDMA is the acronym for the drug commonly known as ‘ecstasy’). On its current track, with updated delays due to COVID-19, MDMA-assisted psychotherapy could be approved for treatment of PTSD by 2022. Psilocybin therapy is also the subject of FDA-approved clinical trials for the treatment of depression.

Additionally, in 2019, activists in Denver submitted a ballot initiative to deprioritize prosecution of adult psilocybin possession and use. It passed, making Denver the first city in the U.S. to reduce the threat of criminal penalties associated with psilocybin for personal use. Several months later, the Oakland, Cal., city council approved a similar measure for a variety of fungi- and plant-based psychedelics. Emboldened by these victories, activists have launched a handful of upcoming state and local initiatives, including a potential ballot initiative to create a scheme of regulated psilocybin products and services in Oregon.

The state of psychedelic medical research

Psychedelics show promise in repeated, but relatively small studies. In one recent study, MDMA-assisted psychotherapy was found to be two to three times more effective at treating PTSD than conventional pharmaceutical treatments. Roughly two-thirds of patients were no longer diagnosable with PTSD after a handful of therapy sessions, compared to less than half of those treated with conventional pharmaceuticals. Based on the unusually high efficacy of MDMA compared to more established approaches, the FDA granted it a rare “breakthrough” therapy designation to accelerate its development for this indication.

Both psilocybin- and MDMA-assisted therapy show promise in treating a wide variety of mental health disorders, including: anxiety, alcohol abuse, and — perhaps, the most studied issue — depression.

The exact mechanisms by which psychedelics produce such strong clinical effects are still being studied. At the highest level, one promising hypothesis seems to be that psychedelics treat mental illness by strengthening the portions of the brain responsible for dealing with difficult emotions. This differentiates psychedelics from more conventional treatments such as antidepressants, which inhibit neurotransmitters associated with particular emotional states to prevent patients from feeling acute psychological episodes.

Ironically, psychedelics are often feared in popular culture for how they can trigger intensely distressing thoughts (so-called “bad trips”). But under the care of a trained therapist, it appears that the act of confronting distressing memories and ideas within an altered mental state allows patients to find long-term relief from depression, anxiety, and personal trauma.

Rigorous medical studies can cost millions of dollars. Early attempts at finding financial backing were hindered because the regulatory and reputational complications of psychedelics deter traditional institutional support. This vacuum in funding has meant that much of the initial research has been funded through private philanthropy following the rise of the tech industry, which has a well-documented association with the ’60s counter culture (Steve Jobs famously said that taking LSD was one of the most important decisions he ever made). Culturally, psychedelics hold less stigma among West Coast investors and entrepreneurs, with notable outspoken examples. The octogenarian venture capitalist George Sarlo, for instance, credited psychedelics with helping him overcome the trauma of being a Holocaust survivor, and was one of their early champions in Silicon Valley.

Although it has yet to become a major aspect of medical research, the consumption of small amounts of psychedelics, known as “microdosing,” is a growing trend, especially among knowledge workers. Some believe that microdosing can facilitate creativity and help with subacute mental distress, such as career burnout. Microdoses, which are doses so small they are sub-perceptual, anecdotally appear to have some positive effects on creativity and depression, although there is not enough evidence for conclusive findings.

Perhaps most importantly, the trend in microdosing illustrates the fascinating way in which the underground use of experimental therapies and scientific research are interwoven. Many of the techniques and use cases for psychedelics have come from studying underground use, where practitioners or enthusiasts will illegally test new ways in which psychedelics can solve mental health problems. Scientists will often solicit users online to investigate how they use psychedelics therapeutically, helping them generate new hypotheses for clinical research.

With the expected success of the FDA trials for MDMA- and psilocybin-assisted therapies, there will no doubt be complications to expanding their access to millions of people without experience with psychedelics. The next phase of medical research may explore additional psychedelic substances and applications for additional indications, as well as techniques for safely administering psychedelic therapies at scale.

Potential abuse and risks in poorly regulated scenarios

When psychedelics become legal through ballot initiatives or regional legislation, they increase their availability for use outside of licensed medical supervision. Under scenarios where psychedelics are loosely or poorly managed, could they be prone to abuse and become a public health issue?

Evidence on the risks of legalizing psychedelics comes from the countries where they are already commercially sold. In the Netherlands, a legal loophole permitting the sale of magic mushroom truffles has allowed a cottage industry of retail-packaged psychedelics and retreat centers to thrive. Countless tourists consume magic mushrooms freely sold at “smartshops” every year. Truffle dosages are quite imprecise. One popular variety, for instance, indicates the amount of active psilocybin by the number of Saturn-like stickers on the front of the package (five planets is supposed to be a stronger high than three planets and so on).

Smartshops advertise events such as “microdose magic truffle yoga,” where participants, some of whom have never done drugs, freely consume psychedelics in an environment that is as accessible as any normal recreational class. No formal counseling is provided, participants are not screened and then are left to continue their day after.

Psychedelic “retreats” have become more commonplace, as knowledge of their therapeutic uses has proliferated. Weekend magic mushroom retreats with unlicensed practitioners can cost thousands of dollars and be booked months in advance, with participants flying in from all over the world. Many retreats involve ritualistic ceremonies thought to help participants prepare for the experience, develop clear intentions, and deal with personal challenges.

Given its unregulated nature, the Netherlands may arguably represent the upper limit of potential harm from psilocybin truffle legalization. A review of psilocybin harms in the Netherlands for Regulatory Toxicology and Pharmacology finds that “the use of magic mushrooms rarely (if ever) leads to physical or psychological dependence, that acute and chronic adverse effects are relatively infrequent and generally mild, that public health and public order effects are very limited and that criminality related to the use, production and trafficking of magic mushrooms is almost non-existent.”

There are other psychedelics not currently being considered by the FDA, but which may pose more substantial health risks. These include ayahuasca, a powerful hallucinogen known for sparking religious experiences among indigenous people living throughout the Amazon — from Peru and Ecuador to Colombia and Brazil — for thousands of years. The life-long use of ayahuasca within indigenous cultures has provided researchers a rare opportunity to study the long-term cognitive impacts of psychedelics. At least one study showed no signs of impaired cognitive functioning among long-term users, even in the rather extreme instances when consumption begins in-vitro and extends from childhood to adulthood (it is not uncommon for pregnant and nursing mothers to participate in ayahuasca ceremonies).

In clinical research, a recent overview of psychedelics’ long term impact found few adverse reactions when participants were properly screened and managed. MDMA abuse is probably the most well-researched of the synthetic psychedelics. Some studies suggest that frequent users may suffer cognitive decline, but the evidence is complicated by the fact that such users often take MDMA in combination with other illegal substances.

There is also concern that psychedelics lend themselves to predatory facilitators, who exploit their position to engage in sexual abuse or other coercive behaviors. This is common in South American cultures that take psychedelics as part of ritualistic ceremonies. The Netherlands recently made a ruling against the largely unenforced or regulated market for ayahuasca facilitators, as well, when a fatality was linked to a psychedelic gathering. Facilitators often brew or grow their own psychedelic compounds and, without better public ratings and regulation, it is difficult for users to know what precisely they are consumer, and whether they are consuming it in a truly safe setting.

Finally, a special note should be made about Iboga, a root-based psychedelic that has become a controversial treatment among drug addicts, especially those with severe addictions to opiates. The root appears to be able to treat both the psychological and the neurochemical causes of opioid addiction. Observational evidence suggests that it is promising for conventional-treatment-resistant addicts, but the ceremonies in which these take place are so intense that they require unusual levels of counseling and security prior to admission. However, it is difficult to disentangle the therapeutic potential of Iboga from the harms reported in its current underground use.

The case for unleashing medical research funding

Some agencies dedicate significant financial resources to mental health. For instance, the Department of Veterans Affairs recently proposed increasing its mental health budget by $682 million in fiscal 2021. This is especially timely given growing calls to fund mental health services in response to the COVID-19 pandemic.

Even when psychedelics may represent a safe and effective treatment, it is difficult for traditional funding institutions to allocate budgets to novel therapies, much less to fund a network of therapists trained in psychedelic-assisted treatments. Dedicated grants could overcome institutional inertia. Recognizing the need for targeted grants, in February of this year Israel became the first national government to give financial support to MDMA-assisted psychotherapy.

Funding could also go to studying law enforcement statistics, public health risks, and use among the population, which could inform future legislation. Yet unfortunately this research is restricted by the prohibition on the use of federal funds for studying medical uses of Schedule 1 drugs.

Last summer, New York Rep. Alexandria Ocasio-Cortez proposed an amendment to strike the long-standing rider in appropriation bills that restricts the use of federal funds for activities that could support the legalization of Schedule 1 drugs (positive medical research could have the effect of descheduling psychedelics). While the amendment narrowly failed, it brought new attention to the issue.

Laws that broadly target Schedule 1 drugs have a chilling effect on risk-averse research institutions, even when such drugs are going through FDA trials. Barriers to public grant funding have therefore been a significant barrier to finding universities and other research organization willing to house privately funded studies.

The Niskanen Center has written about how the FDA responded to the COVID-19 pandemic by changing rules to allow for more rapid innovation. In additional to treatments for the virus itself, the FDA should consider expediting promising therapies for mental health, as well. The epidemic has imposed an enormous toll on families who lost loved ones, and millions of Americans who lost their livelihoods. At the very least, we should ease restrictions on the use of public funds to study medical uses of Schedule 1 drugs that are going through, or have already gone through FDA trials.

The case for regional enforcement

The city of Denver recently convened a psychedelic advisory group (the Psilocybin Mushroom Policy Review Panel) to advise on policy issues surrounding decriminalization. Regional policymakers are unlikely to have much expertise on hand to deal with grassroots-inspired reforms. As such, these committees can help staff and agencies handle the intricacies involved with managing psychedelic issues.

Among other benefits, advisory committees can help formalize the otherwise informal channels between researchers, medical providers, indigenous practices, and experienced psychedelic users. Having committees in place will be important if and when the FDA reschedules MDMA and psilocybin, as states will still have discretion in how licensed practitioners adopt guidelines for treatment.

In response to growing decriminalization, federal law enforcement agencies will also need to decide whether to grant cities and states discretion in enforcing laws against drugs that are still considered illegal under federal standards. One option is to take the template of the Obama administration’s Cole Memorandum, which said that the federal government would not pursue prosecution of marijuana violations and defer to state regulation and enforcement, effectively allowing localities to determine the status of drug policy.

Regional discretion restores low-risk drug enforcement as a state-level issue and permits other states to learn from the example of those that choose to test new ways of handling psychedelic use. Alternatively, given that Congress has full authority to set the legal status of drugs, it could legalize psychedelics through legislation.

Democratic presidential candidate and former South Bend, Ind., Mayor Pete Buttigieg has proposed decriminalizing drugs in line with Portugal’s approach. Decriminalization has the effect of funneling those suffering from drug abuse and addiction through to medical treatment. In the case of psychedelic therapies, decriminalization would reduce the risk of users facing abuse in underground ceremonies.

Colorado has taken a step towards Portugal’s approach by “de-felonizing” Schedule 1 and 2 drugs, making simple possession a misdemeanor instead of a felony. Congress could go a step further and reschedule any drug currently undergoing FDA-approved trials. Schedule 1 classification is for those substances that have no medical value. However, almost by definition, an FDA-approved medical study implies that a drug may have medical value and that it is therefore improper to restrict further research.

Concluding remarks

Mental health is a growing part of America’s health care system, and will be even more important in light of the COVID-19 crisis. Myths surrounding psychedelics overwhelmed the evidence of their efficacy in treating a wide variety of mental health issues. Now, with mounting public pressure and scientific evidence, policymakers are tasked with shepherding psychedelics safely into the mainstream. Ensuring the safety of the public will require unleashing federal funding for medical research, while disseminating the information state and local governments need to design evidence-based policies suited to their local conditions.


Gregory Ferenstein is a San Francisco-based writer and founder of Frederick Research.