Suppose a pilot study on a new smoking-cessation program found that 80 percent of the subjects had quit successfully, most of them without much struggle.

In a sane world — considering that some 400,000 Americans die each year from smoking-related diseases — a dozen labs would have moved quickly, with federal funding, to test that finding, and further success would have generated a quick move toward large-scale trials.

But when Matthew Johnson and his colleagues at Johns Hopkins reported precisely that result in 2012 — in a study with 15 participants, all of whom had previously failed to quit smoking more than once — that rapid follow-up didn’t happen. The treatment involved the use of psilocybin, the active agent in psychedelic "magic mushrooms."

Of course, the Hopkins result may turn out to be a flash in the pan. It had a small sample and no control group, and was not "blind" (that is, subjects and experimenters all knew the material involved was psilocybin, so expectation effects might have influenced the results). But 80 percent success in treating stubborn nicotine addiction is unheard of and worth following up.

Four years later, the only follow-up currently in progress is another study by the same team: a randomized (but still not blind) trial of psilocybin against the nicotine patch. That work is funded by two small foundations, the Heffter Research Institute and the Beckley Foundation. Both Heffter and Beckley focus on the psychedelics; the much larger private and public funders focused on smoking and health aren’t yet interested. That lack of enthusiasm, among both funders and the broader scientific community, speaks volumes about how edgy the whole topic of psychedelics as therapy remains.

Still and all, as we come up on a half-century since the Summer of Love created national awareness of the "psychedelic culture," ideas around these drugs are changing. The psychedelics are attracting fresh attention, in an entirely different key.

The drugs show promise in treating nicotine addition, OCD, and severe headaches

Medical researchers are finding that these substances may have value in managing pre-death anxiety and treating problems ranging from obsessive-compulsive disorder (OCD) to the debilitating kind of headache known as "cluster headache," and there is renewed research (following up on older studies) on their effectiveness in treating alcohol abuse disorders. One striking feature of psychedelic therapies is that just a few episodes are required to achieve long-term effects: The smoking study involved only three guided "trips."

There are also striking findings about nonmedical benefits. An earlier group of studies from that same lab at Hopkins, with Roland Griffiths as lead author, found that a few hours of preparation spaced out over two months, followed by a single day-long session, can produce truly profound psychological experiences.

In surveys after receiving psilocybin, the answers of about two-thirds of the participants suggested their session reached the heights of a "mystical" or "unitive" or "transcendent" experience, as measured by an established set of psychological rating scales. Those scales had been developed to characterize "peak experiences" achieved by spiritual seekers, typically through such techniques as meditation, fasting, waking, ecstatic dancing, and repetitive prayer. "Mystiform" experiences have been reported to shift worldviews, attitudes, mood, and behaviors for the better — sometimes dramatically so.

Test subjects rate their lab-based psychedelic experiences as profoundly meaningful

Indeed, at a two-month follow-up, about two-thirds of the study participants still regarded their day with psilocybin as among the five most personally meaningful and spiritually significant of their lives (on the level of the birth of a child); about one-third recalled it as the single most meaningful and significant.

And there were indeed lasting beneficial changes in mood and behavior, and increased scores on the well-established and hard-to-change personality trait called "openness." Another study from the same team found major positive effects 14 months out.



Such experiences are now on offer in a variety of ritual and nonritual contexts, including both practices of established religious denominations that make use of psychedelics and less formal gatherings of occasional seekers with itinerant leaders.

But even as new evidence comes in, public and official attitudes toward the psychedelics, and their legal status, remain largely stuck in the '60s. Getting our approach to those drugs right this time will require freeing ourselves both from stereotypes rooted in the tie-dyed, bohemian world of Hair and from the categories created by current drug laws and used in the debates about those laws — in particular the notion that all drug policy comes down to "prohibition" versus "legalization."

Psychedelics pose different challenges from the "hard" drugs — or even pot

The psychedelics are "drugs" in two senses: They influence brain chemistry other than by providing nutrition, and they are covered under international drug treaties and US drug laws. Until they can be shown to have medical benefit, they remain in schedule 1 of the Controlled Substances Act, contraband except for research purposes. But in terms of the uses to which they can be put, the harms they create, and the risks they pose, they bear only a vague resemblance to the drugs current drug policies were designed to handle.

Two-thirds of the study participants regarded their day with psilocybin as among the five most personally meaningful experiences of their lives — on the level of the birth of a child

Cannabis, alcohol, tobacco, and the "hard" drugs — heroin and the other opiates and opioids, cocaine and crack, methamphetamine and the other amphetamine-type stimulants — are wildly different from one another, but they share a central risk: the formation of bad and hard-to-break habits ("substance use disorders" to clinicians, "addictions" to the rest of us). Bad habits do form around some of these substances, but those problems are comparatively rare.

In addition, all of the other classes of drugs that constitute the "drug problem" are — or have been, in the case of alcohol — associated with large, flourishing, somewhat organized illicit markets with varying but substantial levels of arrest, incarceration, and trafficking-related violence. Even tobacco has spawned a substantial illicit market to exploit tax differentials across jurisdictions. For the currently prohibited drugs, the damage from illicit markets extends from the US back to source and transit countries such as Mexico and Guatemala.

The psychedelics, by contrast, because they are for the most part used occasionally rather than habitually, generate much smaller illicit markets and relatively tiny amounts of arrest, incarceration, and violence.

That means that the two strongest arguments for legalizing other drugs — reducing the harm done to consumers by taking impure chemicals in unknown quantities and eliminating illicit markets — have much less force with respect to the psychedelics. Rather, the case for making these substances legally available under some set of new rules has to rest on a combination of the value of personal liberty and the good results that can accrue when these drugs are used properly.

There are practical hurdles to proving therapeutic benefits

The benefits of the psychedelics are varied, and do not always fit into neat categories. Some benefits are purely and obviously medical; if psilocybin turns out to treat cluster headaches or OCD, the decision to approve it for those purposes — once the appropriate studies are complete — will require some political nerve but not any rethinking of basic categories.

However, establishing the therapeutic benefits of psychedelic drugs poses special scientific challenges. Even if such studies encountered more support and less resistance than they currently face, meeting the standard of evidence require for approval by the Food and Drug Administration would be anything but straightforward.

The benefits seem to flow not from the chemicals alone, but from taking them with appropriate preparation, guidance, and follow-up. That complicates the research process enormously; it’s much easier to give 1,000 subjects the same dose of an SSRI than it is to give 1,000 people the same preparation for, and guidance in, a psilocybin session.

Psychedelic experiences also seem to be as varied as the people who undergo them; there is no reason to be confident that a chemical and a process helpful to one group of subjects will be equally helpful to a differently constituted group.

There are also financial hurdles. The drug approval process relies on the willingness of a sponsoring manufacturer to invest millions of dollars over a period of years on a molecule that almost always has a fairly low probability of winning final approval.

That willingness, in turn, depends on there being a pot of gold at the end of the research rainbow. Such a pot of gold probably does not exist for the psychedelics, both because they are well-known chemicals whose composition can’t be patented and because their therapeutic uses will typically involve very small numbers of administrations per patient. Thus it’s hard to see pharmaceutical companies spending money on psychedelic research. (There’s a strong case for creating a nonprofit corporation, financed at Treasury borrowing rates, to bring to market valuable drugs that can’t profitably be studied under the existing system; that’s a longer story for another day.)

The fuzzy line separating "medical" from "spiritual" benefits

But medical value is not the end of the story, or even necessarily the most important part of the story. In fact, the line between "medical" and "spiritual" or "religious" use is blurry. Reducing the fear of death among people with terminal diagnoses, for example, is clearly palliative care and therefore considered part of "medicine." There’s now some evidence that the psychedelics can be successfully used for that purpose, as adjuncts to therapy.

But there’s also evidence that the same drugs can be used to reduce the fear of death in people who aren’t under a medical death sentence. There’s no doubt that being relieved of such a primal fear is beneficial. However, since being afraid to die is "normal" and not pathological, reducing that fear isn’t in any obvious sense a medical outcome; instead we’ve handed the problem of existential dread to philosophy, religion, and literature.

Now, it might not seem very important whether we call reduced fear of dying a "medical" benefit or a "spiritual" one, but those categories matter a great deal for legal purposes. A drug for "medical" use needs to be approved by the FDA as "safe and effective," and may only be administered or prescribed by someone with an appropriate qualification (for example, a physician or nurse practitioner). "Safe and effective" has been interpreted to mean "safe and effective in the treatment of some recognized disease or disorder."

Our current medico-legal system is not yet equipped to handle drugs that can improve on "normal": make us "better than well." (For example, Viagra was approved for the treatment of "erectile dysfunction"; the FDA would not have recognized a claim that it improved normal male sexual performance or satisfaction, which is, of course, why most of its users take it.) But that is not the only possible interpretation of the plain language of the Food, Drug, and Cosmetic Act: There’s no logical reason why a drug couldn’t be shown to be "safe and effective" at improving the well-being of healthy people in some regard.

The problem of whether to approve drugs to make people better than well is likely to confront us soon, entirely outside the psychedelic context, as progress is made on cognitive enhancers (as distinct from simple central nervous system stimulants such as the amphetamines). It’s not at all clear what the outcome will be, or even what it should be, given the risk that performance-enhancing drugs (inevitably with unwanted side effects) might become the focus of an "arms race" among competitive students and professionals, as various bodybuilding substances have among athletes.

(One "better than well" idea now gaining some popularity, though to date without convincing scientific evidence to support it, is that periodic use of some of these drugs in doses so small as to be barely detectable subjectively — "microdosing" — might offer a range of "wellness" benefits. There are lots of questions about how to study, and how to regulate, that practice, which is likely to have a risk-benefit profile more like taking nutritional supplements than like taking full-dose psychedelics Some informal trials are in the field now; we might know more about microdosing in a year.)

Some denominations are carving out space for the religious use of psychedelics

Religious or spiritual use is not recognized at all by the drug laws. The use of peyote, which contains mescaline, in Native American ceremonies is exempted from federal law by the American Indian Religious Freedom Act (1978) and its amendments (1994), known as AIRFAA. Over the past decades the courts have begun to carve out religious exemptions under the Religious Freedom Restoration Act (RFRA), which was passed following a controversial 1990 Supreme Court case that undercut previous understandings of the "free exercise of religion."

"Religious use" requires neither FDA approval nor a clinician; precisely what it does require remains to be determined by case law, or by new legislation. The Drug Enforcement Administration is prepared to consider applications from religious groups for permission to worship with otherwise banned drugs, under legal protections less complete than those now enjoyed by the Native American Church under AIRFAA but resembling the protection given to non-native religious groups by court orders interpreting RFRA.

The main applicants, at first, are likely to be practitioners using the Amazonian "tea" called ayahuasca. That potion is brewed from the leaves of a shrub containing the hallucinogen dimethyltryptamine (DMT) and the bark of a vine containing harmala alkaloids. Those alkaloids have their own psychoactivity and also make DMT orally active. (Otherwise DMT must be smoked, snorted, or injected to be effective.)

Ayahuasca, long in traditional use by the indigenous peoples of Amazonia, became the basis of two Christian denominations, the Unaio de Vegetal (UdV) and the Santo Daime. The Brazilian government, after examining the practices of those groups, fully legalized the religious use of ayahuasca in 1992.

The UdV, which is rather tightly organized and involves long-term membership in congregations, established a branch in New Mexico. That branch won a lawsuit in 2006 a under the Religious Freedom Restoration Act; the case, O Centro v. Conzales, established the UdV’s right to import the tea and use it for worship.

The Santo Daime tradition, more decentralized and less congregational, also has attracted people from the US as "ayahuasca tourists" to the Amazon and as participants in ceremonies offered by Santo Daime groups in the US or by freelance practitioners claiming a Santo Daime lineage. A Santo Daime church won its own RFRA case in 2009; how much that precedent protects other practitioners remains unclear, but Santo Daime worship, though relatively widespread, has not been much of an enforcement target.

Both the UdV and groups practicing in the Santo Daime tradition restrict use of ayahuasca to ceremonial occasions, and hold services that fill the several-hour period of altered consciousness that follows taking the tea. This minimizes the risk of people wandering around under the influence and doing or suffering harm.

Group worship also offers some (not perfect) protection against the psychedelic version of clergy sexual abuse. That deplorable practice, exploiting both the vulnerability of people in altered states and their tendency to transfer their awe at the experience to adoration of the person who offers it, has plagued both the psychedelic-tourist trade and informal psychedelic "guiding" in the US. (The same risk could arise in the medical context; best practice seems to be to have opposite-sex pairs of therapists, in part as chaperones for the patient.)

Moreover, the tea causes considerable, and sometimes fairly explosive, gastric distress, which worshipers accept as part of the purification process but which probably chases away people whose interest is merely casual. Thus this set of religious exemptions does not seem to pose much risk of eliding into virtual legalization for mass consumption, as "medical marijuana" has in California.

What about spiritual use that's not explicitly religious?

On the other hand, some of the traveling "shamans" seem to operate on a more or less fee-for-service basis, welcoming all paying customers without doing any real screening in advance or offering any support afterward, when support is sometimes needed: An ayahuasca trip can be as hard on the spirit is it is on the gut. The absence of a congregation deprives seekers of mutual help in dealing with the aftereffects of difficult experiences and in integrating flashes of spiritual insight into their daily lives.

There’s an argument, of course, for allowing the use of drugs that are neither medical nor religious nor performance-enhancing in any measurable way, simply because they provide experiences that their users find pleasurable or otherwise valuable. And that argument is stronger, in two ways, for the psychedelics than it is for most other controlled substances.

First, the value that some people put on their psychedelic use is very high indeed. Here, for lack of numerical evidence, I must substitute anecdote:

I know people who use a variety of nonpsychedelic chemicals, legal and illegal, in what might be called "social" or "recreational" mode, who value that practice, and who would be reluctant to give it up. And I know people who used some of those nonpsychedelic chemicals years ago and still look back fondly on those experiences. (Also, of course, I know some people who intensely regret their past experiences and others who still struggle with substance use disorders, and have known a few who died.)

But I don’t know one former alcohol or nicotine or cocaine or opiate user who believes that he or she is happier or healthier or wiser today as a result of things learned from that past experience. (Cannabis is a partial exception here. MDMA, or "ecstasy," constitutes a major exception; it’s considered a psychedelic by some people but has different effects and raises different policy questions from the classic hallucinogens such as psilocybin.)

The Steve Jobs case for LSD

By contrast, I know many people who say precisely that about the psychedelics: They made use of them years ago, once or on a few occasions, have no particular interest in doing so again, but claim with some fervor that they are calmer, more loving, more creative, more socially useful, better people as a result of those encounters. (Steve Jobs, reflecting on his own experiences, once suggested that Windows would be a much better operating system if Bill Gates had tripped at least once.)

The word that keeps coming up when you talk to people about their psychedelic use is "sacred." Sacredness is not something our contemporary society thinks about very clearly or manages very sensibly.

Those accounts are consonant with the quantitative results reported in the Hopkins spirituality studies. Anecdote is not data, and since I haven’t done a survey to find out how any of my acquaintances have tried the psychedelics with trivial — or bad — results, I can’t say how likely the lasting good results are. Still, that’s what the people I know say, and they don’t say it about other drugs. It would require, I think, substantial evidence of risk to counterbalance those reported benefits.

And that leads to the second point of difference. The risks of the psychedelics — centered on bad acute experiences and their aftereffects and on reckless activity under the influence — are smaller, and more easily controlled with reasonable precaution, than the risks of habituation to alcohol, nicotine, the hard drugs, or even cannabis. For neurochemical reasons — in particular, the acute tolerance effect that makes daily use of these drugs unrewarding — the classic hallucinogens have very limited risks of forming persistent bad habits.

Still, "smaller" doesn’t mean "negligible." Even in well-designed settings, some people — and especially those who are already fragile psychologically — have experiences they aren’t prepared to handle, sometimes with lasting aftereffects.

The word that keeps coming up when you talk to people about their psychedelic use is "sacred" (which, let us not forget, has as one of its meanings "taboo"). Sacredness is not something our contemporary society thinks about very clearly or manages very sensibly, but sacred things are to be handled, at all, only with due care and the right intention. As the Nazi in Raiders of the Lost Ark found out the hard way, if you deal with the sacred disrespectfully, you’re likely to get burned.

The long-run challenge is to build institutions, cultural practices, a supply system, and a set of public policies that encourage thoughtful — one might say "reverent" — use of these powerful materials and discourage casual or reckless use. It’s likely that the policies will play, directly, only a minor role in shaping behavior.

There’s a strong case against making the psychedelics items of commerce; it’s perfectly possible to recognize enormous potential for beneficial uses without thinking that LSD should be promoted and sold the way alcohol is promoted and sold. (Indeed, there are good reasons to doubt that alcohol itself should be promoted and sold that way, or that the alcohol model is a good replacement for cannabis prohibition. Fixing alcohol policy and developing alternatives to commercialization for cannabis will be two long, hard struggles.)

The psychedelic mushrooms and cacti can be fairly easily grown by non-experts; some, especially the mushrooms, can be harvested in the wild, as can a variety of DMT-bearing and harmala-bearing plants from which to brew local versions of ayahuasca. (Note: Harvesting wild mushrooms is not for non-experts; mistakes can be deadly.) It’s hard to see a strong case for criminalizing that sort of self-supply.

For those who want to acquire supplies from others, it would seem reasonable to require that the psychedelics be produced and distributed on a not-for-profit basis, without any advertising. People experiencing the psychedelics for the first time ought to be strongly counseled — if not legally required — to do so with appropriate (which does not necessarily mean medical) supervision. But even such a relatively restrictive approach would require rethinking the very basis of not only our domestic drugs laws but the international drug treaties; neither is a current possibility.

So what is to be done in the short run?

Get a move on medical research. That means securing serious funding — millions of dollars per year — from foundations or wealthy individuals. By contrast with cannabis, research approvals don’t present insuperable barriers; while all research cannabis comes from a single lab, supplies of research psychedelics are available from several sources. Create a corps of guides for medical and spiritual uses alike, with both adequate training — drawing on the expertise developed in decades of informal experience — and a strong professional ethic , mutually policed. Develop reasonable procedures — stiff enough to repel merely pretextual claims, but not so difficult as to seriously burden sincere religious exercise — for granting religious (RFRA) exemptions to the controlled-substance laws when it comes to the spiritual uses of the psychedelics. (Yes, developing those rules will not be easy, and mistakes of permission and exclusion will inevitably be made.) Create not-for-profit sources of supply for both religious and medicauses, minimizing the risk of active marketing by producers. It shouldn’t be hard to find philanthropic sources for the small amounts of capital required. Move toward changes in FDA practice — or, if necessary, in statute — to recognize performance enhancement as a basis for drug approval.

The need to free the psychedelics from the established categories of drug policy means more than crafting appropriate exceptions and exemptions to current laws. It also involves moving past the idea that there are two possible positions with respect to every drug: total prohibition (except perhaps for medical use) and total legalization on a commercial basis. As a longtime critic of both the drug war and the legalization movement, I know from bitter experience how deeply entrenched those categories are. But they’re a bad fit for most drugs, and an especially bad fit for the very unusual drugs called psychedelics.

Mark A.R. Kleiman is a professor of public policy at the NYU Marron Institute on Urban Management and the author of Against Excess: Drug Policy for Results. Find him on Twitter @MarkARKleiman.

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