In this series of blog entries, I’ve been discussing the emerging data on using psychedelic compounds, such as psilocybin (the active ingredient in “magic mushrooms”) and 3,4 methyelenedioxymethamphetamine (MDMA, commonly referred to as “ecstasy”) as a means of catalyzing psychotherapeutic change. I’ve reviewed how these compounds might disrupt overly rigid brain networks that maintain disease states as different as posttraumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), depression, anxiety at the end of life, and substance dependence. We’ve looked at the impressive data (albeit preliminary) from clinical trials utilizing these substances.
Don’t Try This at Home
“Well, Mr. Penn, this is all very interesting,” you may be thinking, “but I treat patients with substance use disorders, and the last thing they need to hear is that indiscriminate use of psychedelic drugs could somehow help them.”
Given my enthusiasm for the preliminary studies, you may be surprised to learn that I couldn’t agree more. As the TV disclaimer goes, “don’t try this at home, kids!”
It is clear that psychedelic compounds are powerful, and they have great potential to help patients with intractable conditions. Yet any compound with that kind of power also has the potential to harm, and that harm should not be trivialized.
The risks of nonclinical uses of these compounds, in which people are not prepared for their effects or are using them in an uncontrolled setting, such as a party or a festival, are very real.
Since the 1960s, it has been known that the subjective experience of psychedelics is largely determined by the “set (mindset) and setting (the physical location, the other people who are present when the drug is taken).”
In the wrong setting, individuals can sometimes feel overwhelmed by the effects of psychedelics. The sudden experience of mental expansion and ego dissolution can be confusing or frightening to the unprepared person who is taking these substances in an overstimulating environment. It is best if these experiences can occur in a controlled setting where the person can be provided support if needed and the experiences processed and integrated after the effects of the drug are complete. In addition, outside the clinical setting the drugs are unlabeled and unregulated, so people may be ingesting dangerous adulterants.
Organizations such as DanceSafe (dancesafe.org) and the Zendo Project (http://www.maps.org/resources/responding_to_difficult_psychedelic_experiences) have responded to these risks with harm reduction efforts such as providing screening for these dangerous adulterants and providing safe spaces for people undergoing difficult psychedelic experiences at large festivals, but the safest environment will come if the drugs are approved and regulated in the same manner as antidepressants, antipsychotics, and other therapeutic compounds.
As studies of psychedelic drugs garner more attention in the popular press, our patients are more likely to show interest in them. Thus, it is important that, as clinicians, we underscore for our patients the difference between therapeutic and recreational use of these drugs. In the former, participants are carefully screened and treated in controlled settings with pharmacologically pure compounds, while in recreational use drugs of unknown composition are ingested with the intention of intoxication in settings that can be overstimulating or even dangerous.
Furthermore, we must communicate that even within a clinical setting these compounds carry attendant risks that can be safely managed in such a setting and should not be used recklessly. Thirty to forty-five percent of subjects in the psilocybin trials reported significant anxiety at some time during the drug administration, but this did not prevent many of those subjects from reporting that the experience was one of the most spiritually important of their lives. This all said, it needs to be underscored that our patients should not be trying to treat themselves with these drugs. If they are interested being subjects in this research, refer them to clinicaltrials.gov to see if there are trials that are enrolling subjects.
Despite these concerns, we shouldn’t let an excess of caution impede the research, which needs to happen to better understand whom these compounds can help, what risks are involved, and ideally, the neural mechanisms through which they convey benefit.
Challenges in the Future
So what do we need as psychiatric professionals, going forward? The first, and obvious answer is, “more data!” The current studies are compelling and exciting, but they are small. A recent Medscape editorial from past APA president Dr Jeffery Lieberman (http://www.medscape.com/viewarticle/847768) called upon the psychiatric profession to lead research into the possible therapeutic uses of these compounds, and not to be caught trying to catch up with a public that has already become convinced of the benefits of the drugs before more thorough research has been completed.
Before we can be certain that these compounds are as effective as they have been in small, exploratory studies, we need larger, phase III trials. However, the challenges of conducting such trials are twofold—one regulatory, the other financial.
Studying drugs on Schedule I of the controlled substance act, the category under which psychedelics are classified, is particularly difficult. Additional permissions must be obtained from the Drug Enforcement Administration (DEA), which adds time and cost to the study. Often, this process is, at best, glacially slow.
Financial challenges further impede the process of conducting larger trials. Psychedelic drugs have been without patents for decades, and they are used, at most, 2 or 3 times in a therapeutic setting. Thus, there is no financial incentive for a pharmaceutical company to pursue the research needed to obtain FDA approval, which leaves the research for this work to be funded by private donors and foundations. A bigger funder is needed—perhaps the National Institute on Mental Health (NIMH) or the Veteran’s Administration (VA), who, sadly, have no shortage of patients with PTSD to treat.
Questions for Clinicians and Researchers
Psychedelic drugs, which have travelled a long arc from being therapeutic agents to drugs of abuse, are again being found to be therapeutic. This presents some interesting challenges to the way we think about psychopharmacology—namely, it places squarely before us the question of “how important is the subjective experience of a drug in determining if it is therapeutic?”
Think about what we tell patients about antidepressants – “you won’t feel anything at first, except maybe some side effects. Then, over time, you should feel ‘more normal’ again.” In contrast, psychedelic drugs do anything but make people “feel normal” for the duration that they are active. Is this disruption of normal consciousness necessary for these drugs to confer their benefit, or can these benefits be conferred without this profound, albeit temporary, shift in consciousness? Or might it be that it is exactly this shift of consciousness, this temporary disruption of rigid brain networks and habitual ways of thinking and behaving, that must happen in order for the change to occur and to persist into the future? These are compelling and intriguing questions, not only for research to answer, but also for us as clinicians to ponder the very mechanisms that drive change in the psychotherapeutic process.
So we stand at a crossroads—do we in the psychiatric profession continue to fear and vilify these drugs as mere intoxicants, or do we choose to study them to learn how they might benefit our patients and how we can better learn about the function of the brain from observing their mechanisms? Will we lead or obstruct? I look forward to reading your comments below.
If this topic interests you, I hope you’ll join me in San Diego at the US Psychiatric Mental Health Congress where I’ll be presenting a talk entitled “Re-Imagining a Brave New World: Can Psychedelics Be Catalysts for Therapy?”
Andrew Penn was trained as an adult nurse practitioner and psychiatric clinical nurse specialist at the University of California, San Francisco. He is board certified as an adult nurse practitioner and psychiatric nurse practitioner by the American Nurses Credentialing Center. Currently, he serves as an Assistant Clinical Professor at the University of California-San Francisco School of Nursing. Mr. Penn is a psychiatric nurse practitioner with Kaiser Permanente in Redwood City, CA, where he provides psychopharmacological treatment for adult patients and specializes in the treatment of affective disorders and PTSD. He is a former board member of the American Psychiatric Nurses Association, California Chapter, and has presented nationally on improving medication adherence, emerging drugs of abuse, treatment-resistant depression, diagnosis and treatment of bipolar disorder, and the art and science of psychopharmacologic practice.
The views expressed on this blog are solely those of the blog post author and do not necessarily reflect the views of Psych Congress Network or other Psych Congress Network authors. Blog entries are not medical advice.