In the interim, however, hurdles remain.
The American Psychiatry Association (APA) recently released a conservative position statement on psychedelics and empathogens such as MDMA. In essence, the organization concluded that psychedelic medicine remains at the clinical stage. At present, there is “inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” APA noted.
While the APA said it supports rigorous clinical research into the compounds, “clinical treatments should be determined by scientific evidence in accordance with applicable regulatory standards and not by ballot initiatives or popular opinion.”
APA’s position confirms that the legitimization of psychedelic medicine is not a given, and growing interest in the compounds could lead to a backlash similar to that encountered in the 1960s.
Psychedelics offer promise and peril as much of the world confronts mental health challenges. Here are some of the top tailwinds and headwinds for psychedelic medicine.
Tailwind 1: Psychedelics could meet a significant need in mental health
While there is a considerable variety of psychiatric medications, their efficacy is highly context-dependent. Selective serotonin reuptake inhibitors (SSRIs), for instance, are among the most widely prescribed drugs.
“Unfortunately, many patients do not respond to these medications or don’t like how they feel when on them,” according to Morgan Stanley’s “Counterpoint Global Insights: Psychedelics” report.
Many psychiatric medications must be taken chronically and can have significant side effects. Conversely, classic psychedelics are typically well tolerated and could have substantial therapeutic effects after a few sessions.
The number of people with mental health struggles is growing. According to the Substance Abuse and Mental Health Services Administration, an estimated 52.9 million adults — or one in five — suffer from a mental health illness in the U.S.
Another factor driving public interest in psychedelic-based therapies is a backlash against current psychiatric medicines — most notably antidepressants.
Early clinical research related to the use of psychedelics in depression is broadly positive. Ultimately, psychedelics could also potentially treat other conditions, including ADHD, PTSD, anxiety and chronic pain, as the Morgan Stanley report noted.
Headwind 1: Psychedelic medicine faces reputational hurdlesWhile MDMA and the classic psychedelic psilocybin have received breakthrough therapy status from FDA, FDA has yet to approve psychedelics or empathogens to treat any disease. In addition, the compounds remain Schedule I drugs, deemed to have a high abuse potential with no therapeutic benefit.
An article in the Journal of Psychopharmacology found that people who have never consumed magic mushrooms believed them to be significantly more dangerous than those with prior experience with the drug. Both groups, however, believed magic mushrooms to generally be less hazardous than other drugs, including alcohol and tobacco.
While clinical research on psychedelics has ramped up in the past decade, such research was mostly prohibited after 1970. While more than 1,000 clinical papers on psychedelics were published in the 1950s and 1960s, the Controlled Substances Act of 1970 effectively blocked psychedelic research for decades after its passage.
The counterculture’s widespread use of LSD in the 1960s and the following prohibition of psychedelics fed a negative perception of the drugs. More recently, a 2021 Hill-HarrisX survey found that 65% of the public believed psychedelics had no medical use.
Tailwind 2: Burgeoning support for psychedelic medicine from patients and authorities
While psychedelics face reputational hurdles, public support appears to be growing.
Michael Pollan’s best-selling book and Netflix series, “How to Change Your Mind,” has helped stir public interest in the therapeutic use of psychedelics.
A growing number of investors are also warming to psychedelics, as the WSJ recently reported.
Several celebrities have entered the fray by describing the power of psychedelics to fuel inner transformation. Green Bay Packers quarterback Aaron Rodgers extolled the virtues of the Amazonian brew ayahuasca, saying it helped his NFL career.
“Most of the work [with ayahuasca] was around myself and figuring out what unconditional love of myself looks like,” said Rodgers, who credited the drug for helping him find a renewed appreciation for football.
A majority of people in the U.S. with mental health issues such as anxiety and depression support the use of psychedelic-based therapy, according to a survey conducted by the Harris Poll in December 2021. In addition, an Irish survey found that 72% of individuals seeking mental health treatment supported further research on the therapeutic use of psilocybin, while 59% supported its use as a medical treatment.
A handful of U.S. cities, including Denver, Santa Cruz and Oakland, have decriminalized natural psychedelics. The state of Oregon is in the process of making psilocybin available in therapeutic contexts.
Headwind 2: Limited clinical evidence for psychedelics
While research into psychedelics has ramped up in recent years, most of the studies have been relatively small Phase 1 or Phase 2 studies.Increased public awareness and commercial interest in psychedelics combined with an ongoing mental health crisis could lead to an uptick in clinical psychedelic use that could “outpace evidence-based research and regulatory approval,” the American Psychiatry Association said.
Given the field’s immaturity, there is a lack of consensus on what psychedelics do to the brain and diverging opinions on dosing and therapeutic protocols.
Furthermore, the decriminalization of psychedelics such as psilocybin in a handful of U.S. cities and Oregon could also lead to a growing number of individuals seeking to use psychedelics in non-traditional therapeutic contexts, which could trigger pushback from psychiatrists and other established mental-health professionals.
Tailwind 3: The potential to accelerate psychotherapyThere are a growing number of anecdotal reports of patients in clinical trials who report a significant reduction in depression, anxiety or PTSD symptoms after encountering psychedelics. For example, in one randomized, double-blind study published in 2016, patients with life-threatening cancer noted a substantial decrease in depression and anxiety after a single experience with psilocybin. Other patients taking psychedelics report shortcutting the time it takes to have therapeutic breakthroughs for depression or anxiety by months or years. MDMA-assisted psychotherapy can also lead to similar breakthroughs. One study found that more than two-thirds of patients receiving such therapy had “durable remission of PTSD diagnosis.”
Much of the reports of swift psychedelic-driven therapeutic improvements, however, remain anecdotal, and it also is clear that psychedelics are far from a panacea.
Headwind 3: Mental health risks of psychedelics
While many anecdotal reports and clinical evidence indicate that psychedelics can help lift depression and reduce anxiety, the drugs don’t always have positive effects. Such drugs can have mental health risks, potentially triggering hallucinogen persisting perception disorder (HPPD) and psychosis in some individuals.
In HPPD, people report seeing perpetual or recurring hallucinations — flashbacks or sensory anomalies. And in some cases, such anomalies can cause significant distress.
The DSM-5 describes the condition as a “reexperiencing of one or more of the perceptual symptoms” involved when intoxicated with a hallucinogen.
An article in Cureus estimated that HPPD occurs in between 4% and 4.5% of people with a history of hallucinogen use. It is difficult to gauge its prevalence, given the lack of data related to the condition.
There are multiple case reports in the scientific literature describing the onset of HPPD after a single psychedelic session. Cannabis can rarely trigger the condition.
The Neurosensory Research Foundation says HPPD is often misdiagnosed, arguing that the medical community is undereducated about the condition.
Tailwind 4: Psychedelics could help kick addictions
While it is possible to abuse psychedelics, proponents note that they have anti-addictive properties. In early studies, LSD, psilocybin and other psychedelics have shown promise in reducing cravings associated with drugs ranging from alcohol to nicotine.
One small study at Johns Hopkins found that 80% of smokers were able to quit after a handful of psilocybin sessions. By contrast, the success rate for the traditional anti-smoking drug Chantix is about 35%.In addition, compulsive use of psychedelics is rare, according to data from the Substance Abuse and Mental Health Services Administration. From 2005 and 2015, the percentage of patients reporting hallucinogens as their primary substance of abuse didn’t exceed 0.1%.
Alcoholics Anonymous co-founder Bill Wilson at one point supported research into LSD as a means of assisting recovery. Later facing backlash, Wilson agreed on an abstinence-only approach to rehabilitation.
The psychedelic ibogaine can reduce opioid withdrawal symptoms. Early evidence points to its potential to support opioid and cocaine abuse recovery. Ibogaine can be potentially dangerous with potential neurotoxic and cardiotoxic properties.
Other scientists are looking to psychedelics for inspiration to find other compounds that may help battle addiction without causing users to “trip.” For instance, researchers at the University of California, Davis and the University of Colorado Anschutz Medical Campus are also working to identify non-hallucinogenic treatments related to psychedelics that could treat substance use disorders.
Headwind 4: Cost of psychedelic therapy
Psychedelic retreats cost in the ballpark of $2,000 to $10,000 where they are legal.
In Oregon, where psilocybin-based therapy is being decriminalized, a single administration session could cost an estimated $1,000 or more.
In the U.S., ketamine infusions for depression could provide a rough cost comparison. An infusion can range from $400 to $2,000.
A central driver of the cost of psilocybin-based or MDMA-based therapy is the need to administer such drugs in a clinical setting with specifically trained clinicians.
Given the uncertainty of payers covering psychedelic-assisted therapy, it is plausible that such treatments will find the greatest use in individuals who can afford to pay for them out-of-pocket.
Tailwind 5: Psychedelic medicine could be more efficient for some patients than traditional psych meds
A growing amount of data suggest that psychedelics can lead to persistent reductions in depression and anxiety. For example, a study published in PNAS in 2020 found long-lasting mood-enhancing effects from participants who had taken psychedelics at events in the U.S. and the U.K. Many psychedelic clinical trials have found statistically significant effects on patients after a limited number of dosing sessions.
And classic psychedelics also don’t appear to be habit-forming, according to BMJ.
Traditional psychiatric medications such as SSRI-based antidepressants and benzodiazepines can have significant withdrawal symptoms. Benzodiazepines also can be highly addictive.
Headwind 5: The specter of psychedelic therapy abuse
A survey published in the American Psychologist raised eyebrows in the 1980s by concluding that 87% of 585 psychologists reported at least occasional sexual attraction to clients. Since then, a number of law firms carved out specialties in sexual exploitation in healthcare, including psychotherapy.
While mental health workers are ethically and legally obliged to respect patients’ boundaries, the prospect of psychedelic-assisted therapy ups the stakes.
One MDMA study participant accused a therapist of sexually assaulting her during therapy, as Quartz reports. MAPS, the organizer of the trial, released a statement referring to such behavior as “unethical conduct of sexual abuse” in violation of its policies and “generally accepted standards of care.”
The growing use of psychedelic-assisted therapy could make such anecdotes more common. An article in the Journal of Humanistic Psychology highlighted “unique challenges that psychedelic practitioners have encountered in their work” related to the boundary dissolution that psychedelics engender.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs