Light at the End of the Tunnel!
Fall, 2014 Newsletter
Dear Heffter Friends and Supporters:
Why did I put that title at the top of this newsletter? Because after so many years of hard work, we now can actually see the final steps coming closer in our process to make psilocybin into a legal medicine! For those of you who were able to attend our annual reception and fundraiser in San Rafael, CA, at Board Member Betsy Gordon’s home on October 12, you know what I am talking about. Let me take this opportunity to tell the rest of you about some of our amazing progress in the past year. If you like what we are doing, please forward this newsletter to your friends!
1. Completion of enrollment in the New York University psilocybin-cancer anxiety study. As many of you know, the NYU psilocybin-cancer anxiety study is using a treatment approach similar to the one carried out by Dr. Charles Grob at UCLA and published in 2011, but enrolling a larger number of patients. Thirty-one subjects received psilocybin treatment; preliminary data analysis began in November, and the manuscript will be submitted for publication in early 2015. The clinicians treating the subjects saw some dramatic responses to the treatment, with very large effect sizes on the various instruments! These results will help our efforts to gain FDA approval for psilocybin-assisted therapy for people in emotional distress from their cancer diagnosis.
2. Johns Hopkins University psilocybin-cancer anxiety study. This study was begun in 2008 and also was completed in late November. Although data analysis is not complete, the overall clinical impression of the investigators is that the psilocybin session experiences have substantial personal meaning and, in some cases, spiritual significance for the participants. Preliminary data analysis should be completed in February or March 2015.
3. Completion of Phase 2 studies. The outcomes of the two clinical trials described above will be considered together with the previous study of 12 cancer patients that was completed by Dr. Grob in 2011. Thus, the total number of patients with anxiety related to a cancer diagnosis treated with psilocybin will be about 87, and based on our preliminary assessment of the results, should result in a statistically significant improvement following treatment. These three Phase 2 clinical studies will be the basis for our request to the Food and Drug Administration (FDA) for guidance in the design of our Phase 3 study for cancer patients. The Phase 3 study will cost many millions of dollars and will involve treating hundreds of patients using the same protocol at multiple clinical sites.
4. Psilocybin Pharmacokinetics. As necessary support for our application to the FDA, we also need to supply the results of a formal pharmacokinetics study of psilocybin. Essentially, volunteers are given various doses of psilocybin and blood samples are taken periodically after administration of the drug. After analysis of the blood concentrations of both psilocybin and any of its metabolites, we are able to characterize how psilocybin is absorbed and handled within the body. This study is being carried out in the Pharmacy School at the University of Wisconsin, Madison. It is enrolling 12 volunteers and should be complete by May 2015.
Clinical Trials of Psilocybin for treating addictions. The way the drug approval process works at the FDA is to allow the petitioner (us) to request approval for one marketing indication. In our case it will be for the use of psilocybin-assisted therapy to treat the anxiety and depression that result from a diagnosis of a life-threatening disease (e.g. cancer). That is our primary focus right now, yet several donors have indicated that they wish to support research into the value of psilocybin as a treatment for treating addictions. Therefore, we also are supporting studies of psilocybin-assisted therapy in treating nicotine and alcohol addiction. We have now seen very positive outcomes for two pilot studies of addiction.
5. Johns Hopkins University Study of Nicotine Addiction. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment, Dr. Matt Johnson’s group conducted an open-label pilot study administering moderate and high doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers, with a mean of six previous lifetime quit attempts, and smoking an average of 19 cigarettes per day for a mean of 31 years. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed abstinence at 6-month follow-up! This observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). The publication describing this open label pilot study was published in September 2014 in the Journal of Psychopharmacology, which has a link here: http://jop.sagepub.com/content/28/11/983.lon. The study was widely covered in hundreds of media reports, which were virtually all positive. Here are some examples:
Matt also authored a piece for the website Reset.me, which was published concurrently with the study and describes the broader implications of the research: http://reset.me/story/psychedelics-treating-tobacco-addictions/. This pilot study is the basis for a large placebo-controlled study just funded by the Institute to conclusively demonstrate the efficacy of psilocybin-assisted treatment for nicotine dependence.
6. Pilot Study of Psilocybin in Alcoholism at UNM. This study is being carried out by Dr. Michael Bogenschutz at the University of New Mexico, Albuquerque. The final study visit was completed on 03/28/2014 and primary data analyses are now complete. The Final Data and Safety Monitoring Committee meeting was held on 08/20/2014. Coding and qualitative analysis of session audiotapes is ongoing. Participants were 10 volunteers with DSM-IV alcohol dependence. Participants received 12 weekly psychosocial treatment sessions. Psilocybin was administered in supervised sessions at weeks 4 and 8. Data on acute effects were available for all participants, and 9/10 completed all outcome assessments. Abstinence did not increase significantly in the first month of treatment (before participants had received psilocybin), but increased significantly following psilocybin administration (p < 0.05). There were no significant treatment-related adverse events. The primary manuscript has been submitted to the Journal of Psychopharmacology. Based on the positive results of this pilot study, a larger two-site, placebo-controlled study is now being planned, with one site at UNM and a second site at NYU. The Heffter video page has an interview with one of the subjects in that study: http://www.heffter.org/video.htm. You also will find interviews with some of the cancer subjects on that webpage.
7. Psilocybin and Emotional Regulation Project at Heffter Research Center Zürich. One of Dr. Franz Vollenweider’s team’s publications on how psilocybin affects emotional regulation in the brain will be featured on the cover of Biological Psychiatry, and is already published online:
Franz’s team is now preparing to study neuroplasticity in depressed patients treated with psilocybin. To learn more about the many publications from Dr. Vollenweider’s group, go to our list of all the projects supported by the Institute, now totaling 80 peer-reviewed scientific publications!
8. Long-term Meditators Study at Johns Hopkins University. This study is being carried out by Dr. Roland Griffiths, and aims to study the effects of psilocybin in long-term meditators. To date, six volunteers have passed screening and one has participated in one or more sessions.
9. Lifetime use of hallucinogens is associated with decreases in suicidal ideation, suicide planning, and suicide attempts. With Dr. Peter Hendricks, University of Alabama, Birmingham, Dr. Matt Johnson of JHU has recently submitted a study to JAMA Psychiatry (formerly Archives of General Psychiatry) suggesting that the naturalistic lifetime use of psychedelics is associated with decreases in suicidal ideation, suicide planning, and suicide attempts. These data are consistent with therapeutic potential of psychedelics and are relevant to the potential rescheduling of psilocybin following the collection of our Phase 3 trial efficacy data. The project also strengthens the collaborative relationship between Matt Johnson and Peter Hendricks, who have published research on psychedelics together (Hendricks et al., 2014, Journal of Psychopharmacology, 28, 62-6), and will work together on a cocaine addiction trial Dr. Hendricks is preparing at University of Alabama, Birmingham.
10. Founding and History of the Heffter Research Institute. Board member David Nichols also wrote a history of the Heffter Institute that was published in the Journal of Psychoactive Drugs this past year. Here is a link to the article:
Dave also presented a poster at the recent annual meeting of the American College of Neuropsychopharmacology (ACNP) titled “The path toward making psilocybin available for medical use,” with coauthors Matt Johnson, Roland Griffiths, and Jack Henningfield, the latter being our consultant at Pinney Associates, who has been guiding us in our approach to the FDA on psilocybin approval.
We at the Heffter Institute express our heartfelt appreciation for your support for the Heffter Institute for the past 21 years! If you like what we are doing to make a psychedelic into a legal medicine, help support our Phase 3 study of psilocybin for anxiety and depression for end of life patients and our addiction treatment studies. Donate either through our PayPal site on the Heffter web page http://www.heffter.org/support.htm, or send a check directly to the Institute at:
Heffter Research Institute
369 Montezuma # 153
Santa Fe, NM 87501
All of us at the Heffter Research Institute wish you a happy holiday season and a productive and healthy new year.
Dave Nichols, Ph.D.