Winter 2018/19 Newsletter
Dear Friends and Supporters,
The Heffter Research Institute is celebrating 25 years of progress this year, having been incorporated in 1993! We are hearing from more and more scientists who are becoming interested in the therapeutic potential of psilocybin-assisted therapy, and 2018 has been an exciting year of expansion, with new projects starting and in development.
We’re supporting an important new study that will be starting soon at the University of Wisconsin investigating psilocybin treatment of opioid addiction. Everyone knows we have a serious opioid epidemic, with increasing overdose deaths. Because psilocybin has helped people with alcohol and smoking addiction, and looks promising for cocaine addiction, opioids were the obvious next place to go.
A problem with treatments that end in complete abstinence from opioids is that patients sometimes relapse and take a dose they took when they were tolerant of high doses. Unfortunately, that may be an overdose that leads to death by respiratory depression. To avoid that, we need to be very careful in the design of the study.
Thus, to be safe, this first research study will administer psilocybin to opioid addicts who are already stable on buprenorphine. Buprenorphine is a drug that blocks the effect of other opioids, preventing overdoses, and also prevents the addictive “high” that people experience. It is a standard treatment for opioid addiction, but requires taking it daily for an indefinite period of time. Initially, the clinicians will determine whether a psilocybin dose adjustment needs to be made and if there are any side effects or safety concerns when psilocybin is given to participants taking buprenorphine. The next step will be treatment studies for people with opioid addiction.
We’re also supporting two new studies at Yale University, which is becoming a new center of psychedelic research. A study of psilocybin treatment of Obsessive-Compulsive Disorder and of the psilocybin mechanism of action in depression are both underway and will be completed in about two years.
Projects on psilocybin treatment of anorexia, and depression in people newly diagnosed with Alzheimer’s Disease are also in development.
What’s Happening Now
Three addiction treatment studies are halfway or more to completion: an expanded study of alcohol use disorder at NYU will enroll 100 participants; an expanded study of nicotine/smoking at Johns Hopkins will enroll 80 participants; and psilocybin treatment of cocaine addiction at U. Alabama, Birmingham, is enrolling a total of 40 participants. A study of long-term meditators at Johns Hopkins is also proceeding and should yield new insights into similarities and differences between meditation and the experience produced by psilocybin.
At Heffter Zürich, several studies are in process that delve further into the neuroscience of psilocybin, now also focusing on treating depression.
What do we hope to accomplish by supporting studies into so many different indications? Readers may not be aware that the FDA only allows new drug applications for a single indication; currently MDMA for PTSD, and psilocybin for depression. Moving drug development along to gain eventual FDA approval for prescription use requires tens of millions of dollars. Obviously, there are not enough philanthropists out there to fund development of psilocybin for all of the other possible indications we are studying.
Therefore, our goal is, first of all, to explore the landscape of what is possible with psilocybin therapy. If psilocybin is ultimately approved by the FDA for treating depression, there have been some doubts that “off-label” use (not FDA-approved for other diagnoses) for any other indication will be allowed. Those waters are untested, however, because there has never been any other drug class where its use may be appropriate for so many different indications: depression, anxiety, addictions of various types, and perhaps obsessive-compulsive and eating disorders, among others.
Our trials are designed to be large enough to be confident that psilocybin therapy is efficacious for this host of disorders, and the final statistics will give us that answer. We believe it is likely that at some point in the future properly trained clinicians will be able to use psilocybin therapy for indications not initially approved by the FDA, such as addictions. That is a debate for another time, but in the meantime, if our studies give the positive results we are expecting, at least we will have opened the door of possibilities for the range of psychiatric disorders that may yield to treatment with a psychedelic drug.
Heffter Research Goals for 2019
Next year, Heffter is focusing attention on serious conditions for which there are currently no reliably successful treatments or cures, such as the studies mentioned above for opioid addiction, OCD, anorexia, and Alzheimer’s. As a nonprofit Institute with limited resources, we have always tried to focus on unmet medical needs where, if successful, our research would have a big impact in creating the data that can be used to justify grants from the National Institutes of Health and other institutional sources. That has been our philosophy from the beginning.
We hope you will continue by our side on this awe-inspiring journey as we support proof-of-concept studies and gather the evidence base for therapeutic treatments that, pending FDA approval, will be available to patients in need. We should point out that inadequate funding continues to be a bottleneck for many of these studies. Donations to Heffter-sponsored psychedelic research can be made at heffter.org/donate/.
News To Share
Thank You To All Our Supporters!
The founding purpose of the Heffter Research Institute in 1993 was to ensure that researchers could pursue important scientific work on psychedelics and their potential uses in basic research and clinical treatment. With your support and donations, we are proud to note that 2018 marks twenty-five years of progress toward our goals! Over that time, we are proud to have been able to provide more than 9 million dollars toward ground-breaking research on psychedelics, and we are continually thankful to the many donors who have made that possible.
Thank you for supporting Heffter this year as we continue to promote psychedelic research. For additional information or to share your thoughts, please email us at email@example.com