Heffter’s Plans for Future Research

  December 22, 2016

With Phase 2 studies on cancer-related depression and anxiety now complete, Heffter is excited to investigate other conditions that might be successfully treated with psilocybin.

Drawing on the scientific expertise and longstanding partnership of the world’s leading investigators of psychedelics, Heffter mentors the next generation of psilocybin researchers and therapists, vets new approaches, supports proof-of-concept studies, and gathers the evidence base for therapeutic treatments that, pending FDA approval, will be available to patients in need.

Click here to Read More

Heffter is vetting new approaches for unmet treatment needs, including:

•  Emotional distress accompanying life-threatening diagnoses such as cancer, AIDS, and Alzheimer’s disease

•  Addictions to cocaine, alcohol, and tobacco

•  Depression that is not being successfully treated

•  Obsessive-compulsive disorder and eating disorders

•  Criminal recidivism

Heffter also envisions basic science research to understand how psilocybin and similar drugs affect consciousness and behavior. Specific questions of interest in this area include the following:

•  What is the relationship between brain processes and subjective experience, including cognition, emotion, and spiritual experience?

•  When psychedelic-assisted therapy produces enduring healing, what changes in brain function and neurochemistry have occurred?

•  What effects can these drugs have on personality structure, creative problem solving, and pro-social behavior?

•  How do other types of psychedelic drugs such as mescaline or LSD, and their methods of administration, compare with each other?

•  Does microdosing with LSD have quantifiable cognitive effects?

Heffter is currently reviewing proposals to conduct this important research and will continue to refine its research agenda to support work being carried out by leading investigators. Your generous support makes all of this possible. Learn more about how to make a tax-deductible contribution to Heffter at https://heffter.org/donate/

Heffter Research Winter 2016 Newsletter

 

 

  December 16, 2016

 

 

heffter-logo

2016 has been a watershed year for the Heffter Research Institute and its programs! We believe that our work is contributing to what we hope will be a paradigm shift in the way that many psychiatric and addictive disorders are treated. We hope you enjoy reading about all of the great things we have accomplished this past year.

Johns Hopkins and NYU Studies of Psilocybin for Anxiety and Depression in Cancer Patients

Our big news is the publication of two Heffter-supported studies on psilocybin treatment of anxiety and depression in cancer patients at Johns Hopkins and NYU on December 1. You can access the free full-text articles by clicking on those links.

Click here to Read More

The story about these studies was widely covered by the media. For example, it was on the front page of the NY Times that day: A Dose of a Hallucinogen From a ‘Magic Mushroom,’ and Then Lasting Peace. An analysis of all the media reporting indicates that the studies were covered in at least 600 media outlets that collectively reach millions of readers and viewers.*

So psilocybin research is now virtually common knowledge. At the end of this letter is the latest list of weblinks to all the online stories we found that mention Heffter’s role in this research.

The next step toward gaining FDA approval for psilocybin treatment of anxiety and depression in cancer patients is to conduct a large multi-site “Phase 3” study. The Usona Institute in Madison, WI has volunteered to pick up the baton and take on this complex and unprecedented project, and the Heffter group of researchers is directly involved in the protocol design and planning. Usona is the perfect organization to do this because they have personnel who are developing expertise in working with the FDA, and threading through all of the regulatory pathways necessary to develop and complete the Phase 3 study. FDA recognition of success in the Phase 3 study will ultimately allow psilocybin to be removed from Schedule 1 of the controlled substances act, and be used as a prescription medicine for this treatment. That has been our goal for a long time!

Publications

Franz Vollenweider’s team at the Heffter Zürich Center published two important papers that help us to understand how psilocybin affects human experience, and correlates those findings with activity changes in the brain. They can be seen in the Neuroscience section of our research publications (papers 4 and 5).

The Johns Hopkins team published two papers based on data from on an online survey of the most challenging psilocybin experience by recreational users, and found that most of them felt they were better off after their experience than before. Nevertheless, the survey revealed that about 10% of those most-challenging experiences led people to seek care. These findings highlight the emphasis we have placed on putting safety first in all of our studies. These papers are also in the Neuroscience section of our publications (papers 1 and 2).

The Hopkins team also published a one-year follow-up of smokers in their pilot study of psilocybin treatment to help people stop smoking, which showed that 60% were still not smoking and more than 85% said their psilocybin experience was among the five most personally meaningful and spiritually significant experiences of their lives. That study is the first paper in the Addiction section of our publications.

Current Research

The following studies are in process at this time:

 

•  Michael Bogenschutz is directing a clinical trial of psilocybin for alcohol dependence at NYU, with 90 patients in the psilocybin group and 90 in the placebo group. This study is a randomized placebo-controlled study that includes functional magnetic resonance imaging (fMRI) before and after treatment of some patients to study the effect of the psilocybin treatment on resting state functional connectivity in the brain. In essence, they are asking “how do brain communication patterns change after successful psilocybin therapy?”

•  Matthew Johnson is conducting an expanded clinical trial of psilocybin for nicotine dependence at Johns Hopkins, with 40 patients in each group. Again, fMRI is being used before and after treatment of some patients to study how the treatment changes brain communication patterns.

•  Peter Hendricks at the University of Alabama, Birmingham, is carrying out a randomized placebo-controlled pilot study of psilocybin-assisted psychotherapy for cocaine addiction. As many of you may know, cocaine addiction is an especially tough disease to conquer. We have seen promising results in the earlier pilot studies of psilocybin-assisted psychotherapy for alcohol and nicotine addiction so we are holding our breath, so to speak, to see if psilocybin-assisted therapy can have similar success in hard-core cocaine addicts. Finding that psilocybin-assisted psychotherapy has broad efficacy in battling a variety of different kinds of addictions would be an extremely important finding!

•  Franz Vollenweider is directing a pilot study of psilocybin for treating chronic depression at the Heffter Zürich Center.

•  Finally, a new young investigator, Dr. Emmanuelle Schindler at Yale University, has initiated a pilot study of psilocybin for cluster headache. Anecdotal reports indicate that psilocybin may not only abort a cluster headache, but may provide a degree of prophylaxis against future attacks.

Future Research

Drawing on the scientific expertise and longstanding partnership of the world’s leading investigators of psychedelics, Heffter mentors the next generation of psilocybin researchers and therapists, vets new approaches, supports proof-of-concept studies, and gathers the evidence base for therapeutic treatments that, pending FDA approval, will be available to patients in need.

Heffter is vetting new approaches for unmet treatment needs, including:

 

•  Emotional distress accompanying life-threatening diagnoses such as cancer, AIDS, and Alzheimer’s disease

•  Addictions to cocaine, alcohol, and tobacco

•  Depression that is not being successfully treated

•  Obsessive-compulsive disorder and eating disorders

•  Criminal recidivism

Heffter also envisions basic science research to understand how psilocybin and similar drugs affect consciousness and behavior. Specific questions of interest in this area include the following:

•  What is the relationship between brain processes and subjective experience, including cognition, emotion, and spiritual experience?

•  When psychedelic-assisted therapy produces enduring healing, what changes in brain function and neurochemistry have occurred?

•  What effects can these drugs have on personality structure, creative problem solving, and pro-social behavior?

•  How do other types of psychedelic drugs such as mescaline or LSD, and their methods of administration, compare with each other?

•  Does microdosing with LSD have quantifiable cognitive effects?

As you can see, we have a very comprehensive program of research that may provide answers to some of psychiatry’s most vexing problems. It is probably safe to say that we have champagne tastes on a beer budget. What that boils down to is having sufficient financial resources to carry out all of the work we described earlier; that is really the biggest obstacle we face. We now have no difficulty finding excited new investigators, or helping them design their protocols and gaining approval to carry them out.

Major academic institutions seem finally to be realizing that we are on to something BIG! And you, our donors, have made that happen. It may have taken us more than two decades to get this far, but the perception of psychedelics as potential therapeutic agents finally seems to be taking hold in the public’s mind.

We at the Heffter Research Institute express our heartfelt appreciation for your support for the past 23 years! If you like what we are doing to learn how psychedelic medicines can help patients suffering from problems that can’t be successfully treated in other ways, and how they can help us understand the connection between the brain and human experience, please help us make more discoveries. Tell all of your friends what we are doing, and please Donate through PayPal with your credit card or account there, 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 productive, happy, and healthy New Year.

heffter-signatures

 

 

Online Media Reports of Heffter’s Role in Supporting and Funding the Psilocybin-Cancer Papers:

 

•  http://www.nytimes.com/2016/12/01/health/hallucinogenic-mushrooms-psilocybin-cancer-anxiety-depression.html?_r=0

 

 

•  https://www.theguardian.com/society/2016/dec/01/magic-mushroom-ingredient-psilocybin-can-lift-depression-studies-show

 

•  http://time.com/4586333/psilocybin-cancer-anxiety-depression/

 

•  http://www.medscape.com/viewarticle/872504

 

•  http://www.baltimoresun.com/health/bs-hs-psychedelics-cancer-20161201-story.html

 

•  http://www.latimes.com/science/sciencenow/la-sci-sn-magic-mushrooms-cancer-anxiety-20161201-story.html

 

•  https://www.washingtonpost.com/national/health-science/hallucinogenic-drugs-relieved-cancer-patients-of-existential-distress/2016/11/30/fed60968-b1ab-11e6-8616-52b15787add0_story.html?utm_term=.3a0c8ef7dc89•  http://www.cnn.com/2016/12/01/health/magic-mushrooms-cancer-patients/

 

 

•  http://www.theatlantic.com/health/archive/2016/12/the-life-changing-magic-of-mushrooms/509246/

 

 

•  http://dailytimes.com.pk/infotainment/01-Dec-16/study-shows-psilocybin-in-shrooms-relieves-cancer-induced-depression

 

 

•  http://www.pbs.org/newshour/updates/treatment-hallucinogenic-mushroom-drug-shows-promise-patients-deep-anxiety/

 

 

•  http://www.techtimes.com/articles/187558/20161202/magic-mushrooms-show-promise-in-easing-anxiety-and-depression-in-cancer-patients.htm

 

 

•  http://www.santafenewmexican.com/news/hallucinogen-eases-depression-in-cancer-patients-studies-find/article_afe016fc-751e-5f46-8b71-42df2d640e8f.html

 

 

•  http://www.redorbit.com/news/health/1113416690/magic-mushroom-depression-anxiety-treatment-120216/

 

 

•  http://mashable.com/2016/12/05/psychedelic-therapies-ptsd-cancer-comeback/?utm_cid=hp-n-1#IanIs0XFHEqQ

 

 

•  http://1320wils.com/assets/files/12-5-16%20Dr_%20George%20Greer.mp3

 

 

•  http://www.citizenoracle.com/2016/12/08/magic-mushrooms-potential-cancer-depression-treatment-single-dosage/

 

 

•  http://www.theverge.com/2016/12/1/13799142/magic-mushrooms-psilocybin-cancer-nyu-johns-hopkins-palliative-care

 

•  https://www.statnews.com/2016/12/01/magic-mushrooms-cancer-anxiety-depression/

 

•  http://www.nbcnewyork.com/news/local/NYC-Psychedelic-Mushrooms-May-Ease-Anxiety-Depression-Studies-Find-403932506.html

 

•  http://www.usatoday.com/story/news/2016/12/01/hallucinogen-cancer-depression-psilocybin/94675346/

 

•  http://www.vox.com/2016/6/27/11544250/psychedelic-drugs-lsd-psilocybin-effects

 

•  https://www.scientificamerican.com/article/psilocybin-a-journey-beyond-the-fear-of-death/

 

•  http://religionnews.com/2016/12/01/study-drug-induced-spiritual-experiences-help-cancer-patients/

 

•  http://www.newson6.com/story/33837409/single-dose-of-hallucinogenic-drug-psilocybin-relieves-anxiety-and-depression-in-patients-with-advanced-cancer

 

•  http://boston.cbslocal.com/2016/12/01/magic-mushrooms-study-depression-anxiety-psilocybin/

 

•  http://nypost.com/2016/12/01/magic-mushrooms-may-help-treat-anxiety-and-depression/

 

•  http://www.cbc.ca/news/health/magic-mushroom-medicine-1.3876078

 

•  http://www.smithsonianmag.com/smart-news/could-magic-mushrooms-one-day-help-cancer-patients-face-down-death-180961264/

 

•  http://www.huffingtonpost.com/entry/psilocybin-psychedelics-cancer-anxiety_us_583ef92be4b04fcaa4d60042

 

•  http://www.vocativ.com/380177/magic-mushrooms-depression-treatment/

 

•  http://www.futurity.org/psilocybin-cancer-anxiety-depression-1307652/

 

•  http://www.gospelherald.com/articles/68498/20161202/spiritual-episodes-of-drug-induced-state-help-cancer-patients-face-depression-death.htm

 

•  http://www.npr.org/sections/health-shots/2016/12/03/504136736/how-a-psychedelic-drug-helps-cancer-patients-overcome-anxiety

 

•  http://www.ecns.cn/2016/12-08/236891.shtml

 

•  http://www.collective-evolution.com/2016/12/09/renowned-clinical-pharmacologist-talks-magic-mushrooms-their-therapeutic-value/

 


*CORRECTION: This post has been updated to use a metric, the number of media articles, that is readily trackable.

 

Heffter-Funded Studies Find Psilocybin Therapy Dramatically Reduces Anxiety and Depression in Cancer Patients

December 1, 2016

 

Two randomized controlled trials published today in The Journal of Psychopharmacology report unprecedented findings on the use of psilocybin to dramatically reduce anxiety, depression and existential distress in cancer patients.

These two studies — reviewed and funded by the Heffter Research Institute and conducted by the NYU School of Medicine and Johns Hopkins University — showed that a single dose of psilocybin, in conjunction with psychotherapy, produced rapid, robust and enduring (for more than six months) antianxiety and antidepressant effects in patients with life-threatening cancer diagnoses.

“These findings, the most profound to date in the medical use of psilocybin, indicate it could be more effective at treating serious psychiatric diseases than traditional pharmaceutical approaches, and without having to take a medication every day,” said Heffter Medical Director George Greer.

Click here to Read More

“The treatment sessions are profoundly moving for patients, and their mystical experiences appear to be linked causally to the dramatic therapeutic responses,” said Roland Griffiths, the principal investigator of the Johns Hopkins study.

“That a drug administered once can have this effect for so long is unprecedented. We have never had anything like it in the psychiatric field,” said Stephen Ross, the principal investigator of the NYU study.

The findings further validate an earlier trial from UCLA, also funded by Heffter and published in 2011 in JAMA Psychiatry, showing similar results in a smaller cohort of patients with terminal cancer.

 

Survey of Difficult Psychedelic Experiences

October 5, 2016

 

The recent survey of difficult recreational psilocybin experiences by Heffter Board member and researcher Roland Griffiths, Ph.D. and his team at Johns Hopkins University draws two main conclusions that at first may seem contradictory. On one hand, psilocybin use outside the medical setting occasionally involves traumatic and potentially harmful experiences, as well as occasionally dangerous behaviors. On the other hand, most people report improvements in their quality of life after these difficult experiences.

The medical research setting provides crucial protections from harm that the recreational setting does not: a psychiatric evaluation to exclude subjects with a history of a serious mental disorder that could recur with psilocybin. Another key protection is the presence of specially trained psychotherapists with experience administering psilocybin to support subjects through distressing and confusing experiences, which can happen to anyone in any setting. Finally, the medical research setting provides hours of both pre-session preparation and post-session integration psychotherapy sessions to help the subject maximize the benefit from the session and ensure the positive impacts are enduring.

Click here to Read More

The relative lack of protections afforded by the recreational setting is apparent in the data. The survey of recreational users found that 24% reported psychological symptoms after their difficult experience, some of which included risky or violent behavior, the need for medical help, and suicide attempts. By comparison, less than 1% of Hopkins medical research subjects experienced enduring psychological symptoms, and no medical research subjects participated in dangerous behavior.

The association of difficult life experiences resulting in personal benefit is well-known and almost goes without saying. Hard work, athletic training, and education are often difficult and yet are widely understood to be effective in helping people improve their lives. But because difficult psilocybin experiences are a rare and different kind of phenomenon in our culture, we don’t associate them with the “no pain, no gain” concept that we are used to hearing about more common life struggles. These survey data appear to confirm that learning from difficulty applies to intense inner experience as well as to the more common difficulties in everyday life.

The findings from this Heffter-funded study also confirm the need to place safety first. Psilocybin is a powerful medicine and it is Heffter’s position that the positive effects found in research to date are most reliably achieved when psilocybin is administered by a doctor with special training and used in a therapeutic setting. Safety has not been demonstrated for psilocybin when used outside of a clinical or laboratory setting, and we caution against recreational use of psilocybin because of potential adverse psychological reactions.

 

Heffter President David Nichols On 50 Years Of Research

April 16, 2016

Please join Heffter Research Institute President and co-founder David Nichols for his presentation “Nearly Half a Century Studying Psychedelics,” an overview of his pioneering career in the field of psychedelic research. Dr. Nichols will appear at 7:00 PM on Saturday, April 30th, at the California Institute of Integral Studies in San Francisco.

“Beginning with his graduate studies in 1969, Dr. David Nichols began research on drug molecules known then as ‘psychotomimetics.’ This talk will roughly chronicle his journey from 1969 until the present, presenting advances in the evolution of thinking about these drugs, now popularly called psychedelics.”

Nearly Half a Century Studying Psychedelics with David Nichols