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Hallucinogenic drug may ease anxiety, depressive symptoms in patients with cancer
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The investigational hallucinogenic drug psilocybin reduced clinician- and patient-reported depression, anxiety and mortality-associated anxiety among adults with cancer, according to results of a small double blind study.
One large active dose of psilocybin — an ingredient found in hallucinogenic mushrooms — also increased quality of life and optimism among this patient population, results showed.
The analysis included 566 study participants recruited via flyers, web advertisements and physician referrals. Most had breast, upper digestive, gastrointestinal, genitourinary or blood cancers. All participants received a formal psychiatric diagnosis before receiving the drug.
Psilocybin was administered in a controlled medical setting, and health care professionals monitored patients closely.
Six months after the final treatment session, nearly 80% of participants continued to show clinically significant decreases in depression and anxiety, and nearly 60% demonstrated symptom remission into the normal range.
Also, 83% reported improved well-being or increased life satisfaction.
Nearly 70% of participants described the experience as one of the top five spiritually significant lifetime events, and approximately 67% of participants characterized the experience as one of the top five meaningful experiences in their lives.
HemOnc Today spoke with researcher Matthew Wayne Johnson, PhD, associate professor of psychiatry and behavioral sciences at The Johns Hopkins University, about the findings and the potential that psilocybin could be used in the clinic.
Question: What prompted you and your colleagues to conduct this study?
Answer: Research in the 1950s through the early 1970s assessed psychedelics — mainly LSD, which is in the same class as psilocybin — as part of treatment of cancer-related distress, such as depression and anxiety. The earlier research into psychedelics during the 1970s stopped, not because of medical concerns but more so because of political concerns regarding the counter culture and its use of psychedelics. Historians of the field view this medical research as some of the threads of promising medical applications. However, they were cut prematurely as an overreaction to nonmedical recreational use. In part, our research is picking up from this promising thread that was unfortunately cut off decades ago. This work is also a continuation of what we have done at Johns Hopkins for about 15 years, mainly with psilocybin and some additional other compounds of a broader class of hallucinogens. We have done work characterizing their effects in healthy individuals, without a disorder to be fixed, to examine the effects in ideal-like situations that involve very careful selection of participants, careful monitoring and follow-up postoperative care. We have uncovered a number of positive findings of use of psilocybin in these patients. We have also shown, in a number of studies, positive attributions where both participants and community observers — such as relatives and coworkers — rate that study participants showed improvements in being more flexible, more open-minded and having a positive change in life priorities.
Q: What did your main findings suggest?
A: We found significantly large reductions in both depressive symptoms and anxious symptoms using widely recognized and validated measures. We observed large reductions in clinical markers of distress following psilocybin administration. Remarkably, we found that those reductions persisted up to 6 months after the session, even though they only received the large active dose of psilocybin once. The antidepressant and antianxiety effects remained for at least 6 months after the experience, which is really unprecedented with psychiatric medications. About 80% of people achieved significant clinical reductions in these symptoms. In about 60% of participants, these persisting reductions were so large that they were no longer considered to have suffered from those disorders and were deemed to be in clinical remission.
Q: How might the se data change clinical practice?
A: Our data will not immediately change clinical practice because it is an experimental medication and it is also a scheduled compound, but they absolutely are strong data that support its clinical development. The next step would be a larger, multi-institutional phase 3 study that would contain a larger number of participants and potentially confirm these results. If the medication — under these conditions — continues to look efficacious and safe, that could prompt a change in scheduling and clinical use outside of the research content. However, I would never recommend or expect it to take the form of the “Take two and call me in the morning” type of prescribing. We will not be sending people home with this medication. If psilocybin is approved, it should be administered in situations like a research study, which is conducted at a medical facility.
Q: What adverse events are associated with this drug?
A: There are adverse effects, as there are with virtually all psychiatric or other medications. They tend to be challenging experiences during the acute administration of the substance. Out on the street, people would call these “bad trips.” These are very powerful substances in their ability to change consciousness or change subjective experience that can sometimes fall into the category of strong anxiety. The clinical prescription for dealing with these events is strong interpersonal reassurance with these monitors or session guides that the person has built a rapport with — meaning, someone who holds the hand of participants and lets them know they are doing fine during the session. These challenging experiences are really the main adverse events associated with taking this drug. The nice thing — compared with other drugs in other classes — is that if these experiences occur, they occur on the day of drug administration when there are professionals who are monitoring these patients and a physician who is able to come to the session room within a moment’s notice should there be a need to administer psychiatric medication. Psilocybin does increase blood pressure modestly, but not much more than one would experience walking up a flight of stairs. This can be a problem for some people with cardiac vulnerability. This is why we monitor the patients and screen for cardiac risks prior to administering the drug. We also monitor blood pressure and pulse throughout the session, and we have procedures in place if these vital signs go above a certain level.
Q: Is there a certain patient population that should not take the drug?
A: People at more severe cardiac vulnerability would not be appropriate for psilocybin. Someone who has hypertension but is on controlled medication can receive psilocybin when administered safely, as long as all other criteria appear to pass for these individuals. Those who have psychiatric vulnerability — such as psychotic or manic disorders — also may be eliminated during the screening process.
Q: Will you conduct further research into the drug?
A: Absolutely. We are conducting a number of studies on this drug. This particular study was conducted in patients with cancer who had anxiety or depression surrounding their cancer diagnosis. We, along with colleagues at other universities, are preparing to conduct a phase 3 trial to confirm these preliminary findings. There are other lines of research. We have conducted pilot research showing promising results using this medication with cognitive behavioral therapy to treat smoking addiction. We are also conducting a randomized trial to confirm these findings. If we continue getting positive results, we will continue with this line of research.
Q: When might psilocybin be ready for clinical use?
A: Clinical use — meaning someone could go to a physician outside of a research study and say they are interested in treatment with psilocybin — is probably as far out as 5 to 10 years from now. But this is a guess. This would require the initiation and completion of a phase 3 trial, and there are additional steps after this with the FDA, which is a little more complicated than a traditional approval of a drug because this is a schedule 1 compound and is in the same class as heroin. Psilocybin should not be prescribed by physicians right now. It is not ready for prime time yet.
Q: Is there anything else that you would like to mention ?
A: The number one on our priority list is safety. We recognize and agree that there are real absolute risks with these types of drugs. Safety has been central to everything we have done. – by Jennifer Southall
For more information:
Matthew Wayne Johnson, PhD, can be reached at Johns Hopkins Bayview Campus, 5510 Nathan Shock Drive, Behavioral Biology Research Center, Baltimore, MD 21224; email: mwj@jhu.edu.
Disclosure: Johnson reports no relevant financial disclosures.