Daily Archives: November 10, 2020

Psychedelics are psychoactive substances that historically have attracted exaggerations of benefits as well as alarmism. As with most subjects that bring out extreme views, the scientific data provide a more grounded perspective. Sometimes, the scientific data require further clarification. We are responding to a thought-provoking opinion piece by Eddie Jacobs published on October 11, 2020 entitled What if a Pill Can Change Your Politics or Religious Beliefs? Some could mistakenly take away from the piece an unrealistic impression that is not supported by the scientific data. We worry that this may lead to alarmist reactions.

Jacobs piece raises ethical questions regarding emerging research suggesting psychedelics may be effective psychiatric treatments. Specifically, the concern is that psychedelic therapy could shift patients political beliefs in one direction along the political spectrum or change [their] religious beliefs. We agree that as with any emerging medical treatment, psychedelic therapy prompts important ethical considerations; however, we believe that the possibility implied in the headlinethat psychedelics prompt substantial change in political and religious beliefs or affiliationsis not supported by the current scientific data.

To be clear, Jacobs did not mention affiliations, but we believe readers might reasonably take away this interpretation. We suggest that there is no evidence that people change political or religious affiliations from psychedelic treatments, and current evidence for other kinds of belief changes is weak. Below, we address the three major studies mentioned in the original article.

The concern about political beliefs largely rests on evidence from a small pilot study of psilocybin for treating depression. The study showed an average reduction on a measure of authoritarianism from baseline to one week after psilocybin in seven people. Authoritarianism, as it is operationalized here using five questions that were reduced from the original version of the scale, likely does not fit neatly into a particular political party. Many people, for example, would likely disagree with the scale item The law should always be obeyed, even if a particular law is wrong, regardless of political affiliation.

It is also not clear that a reduction in authoritarianism (or increase in libertarianism or social/moral liberalism, the other end of the scale spectrum) holds a relation to present political affiliations. There are abundant historical examples of both left-wing and right-wing authoritarian governments (for example, communism and fascism, respectively). Moreover, in a country such as the United States, the major left-and right-leaning parties have generally had no universal leaning toward either individual freedom or state control. The position taken along this continuum is highly dependent on the subject (for example, business regulation, abortion, gun control, social constraints on sexual behavior). In fact, the developers of the scale in question preferred not to use the term liberal in reference to the scale because that term had a political meaning in the United States that went beyond what the scale measures.

Beyond the theoretical issues with mapping authoritarianism onto present political parties, there are also statistical concerns with this study. The finding about reduced authoritarianism barely met the threshold of significance and with a one-tailed t-test. A one-tailed test provides a lower standard for achieving significance compared to the much more common two-tailed test. It is unclear if the reduction would have been significant with a two-tailed test. In any case, the effect did not last. At the 712 month follow-up the decrease was not significant, even according to the lower standards of the one-tailed test.

Jacobs piece alluded to another study about political beliefs, a 1971 study exploring the association between LSD increased liberalism. This study compared three groups: 1) people who had taken LSD as a medical treatment, 2) people who had taken LSD on their own, and 3) people who had not used LSD. Only those who had taken LSD on their own indicated more support for policies like individual freedom and foreign policy liberalism compared to those who had not taken LSD.

It is possible that those who were willing to take LSD outside of medical treatment may have already been more influenced by the liberal hippie movement that encouraged these beliefs at that time (Jacobs notes that this is correlational and not causal data). Importantly, no differences were found in this study between the political beliefs of those who received LSD under medical treatment compared to those who did not take LSD. Therefore, this study actually suggests that medical psychedelic treatments do not alter political beliefs!

In terms of religious beliefs, Jacobs piece points to a concern about belief change on the basis of a survey study by our group at Johns Hopkins. This survey specifically recruited individuals who had a God encounter experience after taking a psychedelic outside of a research context. Before having such an experience during their psychedelic session, 21 percent retrospectively identified as atheist, whereas only 8 percent did after the experience. This decrease was accompanied by a decrease in identification with major religions, alongside increases in spiritual types of self-identification.

Crucially though, this study was in no way representative of the general public, as only people who reported encountering God or a similar phenomenon were included in the study. This was a very specific sample of people reporting a special kind of experience or interpretation of experience. The study cannot provide an estimate of population rates. Belief changes of a religious type would, of course, be massively inflated in this sample, and it is therefore not appropriate to draw generalized conclusions about belief change from psychedelic treatments based on these data.

Lastly, the piece cites the observation that under clinical conditions psychedelics increase, on average, a personality trait called openness to experience, a finding first reported by our group at Johns Hopkins and now replicated by others. Unlike the political and religious effects, this phenomenon appears more robust. However, while psychedelics might be unique in their ability to prompt a change in a personality trait with a short-term clinical procedure, they are not the only clinical intervention that can cause changes in personality traits. A large meta-analysis of over 200 published studies examining the effect of psychiatric treatments on personality traits found that personality was indeed changed.

Regardless of whether the intervention was a psychotherapy or a medication such as a traditional antidepressant drug, these changes reached a moderate effect size for increases in the trait of emotional stability, similar to the effect size observed for the increase in personality openness to experience from psilocybin. Lastly, the correlation between openness to experience and liberal political views is small, accounting for only around 2 percent of the relationship between the two variables. In other words, the pathway from psychedelics through openness to experience to political belief change is, for all practical purposes, negligible.

While data from studies are always paramount, we note that in the first authors experience interacting with hundreds of psilocybin study participants, he does not recall any spontaneous claims of changed political or religious affiliation in either direction.

Our primary point here is that that existing data do not suggest that meaningful changes in religious or political beliefs are likely from psychedelic therapyand certainly not changes in political or religious affiliation. There is some evidence that psychedelic therapy can prompt changes in ones sense of spirituality, but this term is so broadly and variously defined that it does not even necessarily relate to supernatural beliefs, and it can refer to things like ones values or sense of connection.

As with many interventions, there are cases in which individuals change in their values, attitudes and/or beliefs after a psychedelic experience. The frequency and magnitude of these occurrences are empirical questions for future research to address, but the current data simply do not support the idea that psychedelic treatments result in meaningful changes in political or religious beliefs or affiliation.

Psychedelic medicine, like any new treatment, no doubt raises important and challenging ethical issues. Consent procedures in psychedelic trials by our research group (and by other groups to our knowledge) already warn that personality and attitude changes are a possibility. Of course, this should also be done with patients if psychedelics are approved as medicine. Psychedelic experiences are sometimes held as among the most meaningful in ones life, and may be interpreted to have philosophical or spiritual import, likely depending on the orientation of the participant. Such effects present the opportunity for ethical pitfalls by clinicians.

These and other challenges will call for important contributions from ethicists. However, we must also be careful to keep any given concern in perspective and convey realistic risks to the public and patients. From this perspective, we believe, based on the data, that major shifts in political or religious orientation or beliefs are not among the likely risks associated with this treatment. As psychedelic researchers, we believe it is important to remain vigilant against excesses in enthusiasm as well as alarmism.

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There's No Good Evidence That Psychedelics Can Change Your Politics or Religion - Scientific American

A growing number of companies are asking investors to try psychedelic drugs. You may flash back to the 1960s, or to the cannabis stock bubble of 2018, but theres nothing recreational about the current interest in psychedelics, at least among psychiatrists and their most desperate patients.

I do believe that psychedelics hold significant promise as therapeutics, says Jordan Sloshower, a psychiatrist at Yale Medical School who is studying the mushroom ingredient psilocybin as a depression treatment. A number of psychiatric patients get no relief from existing drugs, and the industry has had little new to offer them. So some patients turned to the oldest psychoactive substances knownmagic mushrooms, ayahuasca, and ibogaine. Encouraging anecdotes inspired researchers like Sloshower to test the claims of these drugs, as well as newer ones like MDMA, the effective ingredient in the party drug Ecstasy. On Tuesday, voters in Oregon and the District of Columbia decriminalized adult use of psilocybin mushrooms.

Now, entrepreneurs are tapping public markets. In September, U.K.-based Compass Pathways (ticker: CMPS) debuted on the Nasdaq at $17 per depositary share. Its stock has since doubled to $36, for a market value of $1.2 billion. Compass is testing a proprietary formulation of psilocybin in patients whose depression wasnt helped by standard treatments.

Mind Medicine (MMED.Canada), or MindMed, went public in March on Canadas NEO exchange. At a recent price of 1.21 Canadian dollars, it has a market cap of C$340 million ($260 million) and plans to develop drugs derived from ibogaine and ayahuasca. Field Trip Health (FTRP.Canada) started trading in October on the Canadian Securities Exchange, where its stock now goes for C$2.90, valuing it at about C$150 million. Field Trip is setting up clinics to administer ketamine, a legal anesthetic that has antidepressant and psychedelic properties in low doses. Trials on safety and effectiveness have just begun.

It isnt yet clear whether businesses like Compass or Field Trip will be clinics or drugmakers. Asked about that, Compass chief executive George Goldsmith said the question was premature. Investing in these stocks is probably premature, too.

Mood disorders like depression affect more people than any other psychiatric illnesses. Most patients are helped by generic antidepressants and psychotherapy, but those treatments dont work for the several million Americans with treatment-resistant depression. Psychiatrists also struggle to help patients whose brain injuries have left them with post-traumatic stress disorder, or PTSD.

Research on psychedelics screeched to a halt after Congress banned the drugs in 1970. But stories circulated of patients who claimed long-lasting relief using psilocybin or LSD. In the past decade, psychiatrists at Johns Hopkins, UCLA, and New York University conducted small studies. The results were promising, so nonprofit groups got the governments blessing to sponsor larger trials.

Usona Institute, a nonprofit, is testing psilocybin for depression, while the Multidisciplinary Association for Psychedelic Studies, or MAPS, is in Phase 3 trials of MDMA for PTSD. The Food and Drug Administration designated both studies as Breakthrough Therapies.

Dozens of U.S. clinics are using ketamine therapy to treat depression. Conventional antidepressants take weeks to start working, but a ketamine infusion gives quick relief that lasts a few days or weeks. Higher doses have a psychedelic-like effect that can help patients achieve psychotherapeutic breakthroughs and long-lasting relief, says Veronika Gold, a co-founder of San Franciscos Polaris Insight Center.

Properly run psychedelic-assisted sessions are time consuming, Gold says, and therapists require training. Just being a regular doctor or therapist does not give you the knowledge to use these medicines, she warns.

Generic ketamine can be had for a few dollars a shot. But last year, Johnson & Johnson (JNJ) got FDA approval for Spravato, a kind of ketamine delivered as a nasal spray. It lists for $850 a dose. J&J has said Spravatos approval required eight years of clinical trials, but clinicians like Gold and Sloshower note that those trials didnt prove it was more effective than generic ketamine.

The psychedelic community has a collective ethos that honors open science and the native cultures that first used these drugs. It is wary of proprietary products like Spravato.

But investors have another reason to be wary: Its unclear how the newly public companies will make a profit.

Field Trip plans ketamine clinics, but executive chairman Ronan Levy has his hopes on a proprietary psychedelic he aims to have in Phase 1 trials by 2022. In its Canadian listing statement, Field Trip estimated it will need $12 million to get through the next year, which is a little less than what it had in its coffers. Levy tells Barrons Field Trip will be the Home Depot for mental health and personal growth.

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Like Field Trip, MindMed has no revenue. Through June, MindMed had a deficit of $14 million, but a stock offering last month left it with $38 million in cash to fund early studies of LSD, MDMA, and other psychedelics.

After its IPO, Compass has $175 million in cash. The FDA designated COMP360, its psilocybin product, a Breakthrough Therapy for treatment-resistant depression, and Compass is conducting a trial. But if COMP360 makes it to market, it could find itself competing with psilocybin from Usona. Such nonprofits may be willing to provide psilocybin-based products at cost or for free, undermining our potential market for COMP360, notes Compass prospectus.

Write to Bill Alpert at william.alpert@barrons.com

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Psychedelics Take a Trip to the Market. Its a Long Road. - Barron's

UPDATE: Both Oregon and DC voted to loosen restrictions on psychedelic drugs, as part of a major rejection of the war on drugs seen on Election Day.

The US has a near-total criminal prohibition of psychedelic drugs. In Oregon and Washington, DC, voters are being asked if theyd like to change that.

Oregons Measure 109 asks voters whether psilocybin mushrooms, also known as magic mushrooms, should be allowed for medical purposes.

In Washington, DC, voters are being presented with Initiative 81, which could decriminalize a range of psychedelic plants and fungi.

The measures are seen by many activists as the next stage in scaling back Americas war on drugs, now that marijuana legalization has already reached 11 states and could be legalized in four more in the November election.

Polls show strong support for marijuana legalization, but its unclear how much public backing there is for measures decriminalizing psychedelics or legalizing them for medicinal purposes. Denver became the first US city to vote to decriminalize psychedelic mushrooms in 2019, but no state has decriminalized or legalized psychedelic substances for medical use.

But activists may have an advantage in Oregon and Washington, DC both of which are very liberal, and were among the first jurisdictions to legalize cannabis for recreational use (although DC, due to a bill passed by Congress, still prohibits sales).

The Oregon and DC measures will likely set the stage for future drug policy reform efforts. If two progressive places move forward with their measures, that may signal a wider public appetite for expanding access to psychedelic drugs. If the measures fail especially in an election year that seems very favorable to more progressive causes drug policy reformers almost certainly have their work cut out for them.

A yes vote would effectively decriminalize the non-commercial cultivation, distribution, possession, and use of entheogenic plants and fungi, and ask prosecutors to drop cases related to these substances. Commercial sales wouldnt be allowed.

A no vote would mean DC would not deprioritize the enforcement of anti-psychedelic laws.

A yes on Measure 109 would allow patients 21 and older to buy, possess, and consume psychedelic drugs at psilocybin service centers, under the supervision of trained facilitators.

A no vote would mean patients would not have legal, supervised access to these drugs.

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Live results: Oregon Measure 109 and Washington DC Initiative 81 on psychedelic drugs - Vox.com

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What a Biden Future Looks Like; Are Psychedelics the New Cannabis?: Fridays First Things First - Adweek

Robust new research, published in the journal Translational Psychiatry, is reporting on several years of animal studies showing how a psychedelic drug called dimethyltryptamine (DMT) can promote brain plasticity and induce the formation of new neurons. The research presents evidence to suggest the hallucinogenic effects of the drug may be able to be separated from this neuron-generating mechanism.

Ayahuasca is a hallucinogenic preparation known to be consumed in shamanic and religious contexts by indigenous populations in South America. DMT is the main psychoactive compound in the psychedelic brew, and it has become the focus of a great deal of research due to its profoundly powerful, but short-acting, hallucinogenic qualities.

The recent renaissance in psychedelic science has found hallucinogenic drugs such as psilocybin can induce potent antidepressant effects. Preliminary studies investigating ayahuasca have seen similar antidepressant outcomes. It has been hypothesized that the positive mental health outcomes from these psychedelic compounds stems from their ability to stimulate new neuron production, a process referred to as neurogenesis.

This new research, led by a team of Spanish scientists, set out to understand by what mechanism DMT could induce neurogenesis. Across several mouse experiments the study first established DMT does indeed promote acute neurogenesis, and furthermore, these new neurons can be linked to detectable improvements in the animals memory and cognition.

these [new hippocampal neurons] have a functional impact since DMT treatment during 21 days clearly improved mouse performance in learning and memory tasks, in which the hippocampus is considered to play an essential role, the researchers write in the new study. These observations are in agreement with previous works showing that adult hippocampal neurogenesis plays an important role in these cognitive functions.

Perhaps the most compelling finding in the new research is the confirmation that this psychedelic-induced neurogenesis seems to be produced by a mechanism that is separate to that which generates the drugs hallucinogenic effect.

The hallucinogenic qualities of most psychedelics are commonly thought to be generated through the stimulation of 5-HT2A serotonin receptors in the brain but it is still up for debate whether neurogenesis induced by psychedelics is mediated through the same serotonin receptor activity.

This new research suggests neurogenesis may be mediated through sigma-1 receptors (S1R), which prior research has established are also influenced by DMT. The study reveals the neurogenic effect of DMT could be effectively blocked when mice were administered a S1R antagonist.

The results here obtained indicate that the observed effects of DMT are mediated by the activation of the S1R, the researchers write in the study. In this regard, it has been shown that the stimulation of the S1R by different agonists enhances neurogenesis in the hippocampus.

What all this ultimately means is that is seems possible the new-neuron-stimulating effect of DMT could be divorced from its hallucinogenic and psychoactive properties. Jos ngel Morales, an author on the new research, suggests this promisingly points to new research pathways investigating ways to harness the therapeutic potential of neurogenesis.

This capacity to modulate brain plasticity suggests that it has great therapeutic potential for a wide range of psychiatric and neurological disorders, including neurodegenerative diseases," says Morales.

This research is not the first to raise the possibility of divorcing the therapeutic potential of psychedelics from their hallucinatory effects. Both the US government and commercial pharmaceutical companies are investigating ways to either moderate, or eliminate altogether, the psychedelic effect of psychedelics. However, there is considerable debate within the psychedelic research community as to how fundamentally important the overwhelming psychoactive experience actually is to the drug's subsequent therapeutic benefits.

"The challenge is to activate our dormant capacity to form neurons and thus replace the neurons that die as a result of the disease, notes Morales. This study shows that DMT is capable of activating neural stem cells and forming new neurons.

The new study was published in the journal Translational Psychiatry.

Source: Complutense University of Madrid via MedicalXpress

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How psychedelic DMT promotes the production of new brain cells - New Atlas