Yale University, Department of Psychiatry

 

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Purpose:

This study will investigate neurobiological and psychological effects of psilocybin-assisted therapy in people with major depressive disorder. The primary hypothesis is that psilocybin administered in a therapeutic context will result in neuroplastic changes that parallel improvement in symptoms of depression.

Recently there has been increased interest in microdosing LSD, that is, using doses of LSD that are not psychoactive (typically 10 micrograms).  A standard recommendation is microdosing every three days. The basic idea derives from earlier studies of psychoactive doses of LSD or other psychedelics...

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.

Study findings published Thursday by Johns Hopkins and New York University School of Medicine researchers indicate psychotherapy fueled by a hallucinogenic called psilocybin, the active ingredient in the mind-altering drug known as magic mushrooms, could reduce psychological illness and distress among patients with life-threatening diagnoses....

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.

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.