Psilocybin therapy

Psilocybin therapy is the use of the psilocybin (the active ingredient in psilocybin mushrooms) in a therapeutic context. It is one of several forms of psychedelic therapy. As of 2020, psilocybin therapy is not used in standard medical practice and is illegal in most of the world. Research to date has shown significant clinical benefits, but larger, more rigorous trials are underway. Research has applied psilocybin therapy to obsessive compulsive disorder (OCD), anxiety and depression in patients with cancer diagnoses, tobacco addiction, and alcohol use disorder.

Research

Several rigorous studies have been conducted on psilocybin therapy.[1] These have studied its effectiveness for treatment of obsessive compulsive disorder (OCD),[2] anxiety and depression in patients with cancer diagnoses,[3][4][5] tobacco addiction,[6] and alcohol use disorder.[7] All of the studies showed clinical efficacy and none reported clinically significant adverse effects.[1] Further studies are underway as of 2020 with improved study designs and larger sample sizes.[1]

Therapeutic effects of psychedelics such as psilocybin on a range of mental pathologies appear to be explained by changes at the level of molecular genetics, in turn triggering neuronal activity, causing entropic brain activity and thereby mystical experiences.[8] Psilocybin may be glutamatergic and influence neurotransmission in prefrontal-limbic circuits of the brain, causing neuroplastic changes that bring long-lasting antidepressant effects.[9] Many aspects of the biological mechanisms of therapeutic effects caused by psilocybin remain uncertain.[8]

Safety

During the 1950s and 1960s, research with psychedelics was conducted in the absence of rigorous guidelines. Lack of informed consent led to substantial and long-lasting harm to some subjects, averting the public away from use of psychedelics in medical practice. Further, unsupported claims led to drug abuse in the absence of a formal and supervised setting.

More recently, research on the effectiveness of psilocybin therapy has been conducted under strict ethical guidelines, with fully informed consent and a prescreening to avoid people with psychosis taking part.[10] Additionally, the experimenters conducting it are trained to properly administer the drug, and suggestions for experiments have to comply with the APA's ethical guidelines as well as pass expert reviews before they can be carried out.[11] Furthermore, potential harms of psilocybin, such as psychosis and hallucinations, have only been linked to recreational and unsupervised nonmedical use of the drug.[12] Experts agree that the drug treatment is still under development and they do not recommend to the public to try and self-medicate their mental states. Acute effects, such as anxiety, fear states, and increases in heart rate and blood pressure, can occur during the time of drug action, and without supervision dangerous behaviors can emerge. However, trained specialists can readily manage this and usually no negative long-term effects are reported.[10] In comparison to many other drugs, psilocybin is relatively harmless physiologically.

History

In 1959, Albert Hofmann, as Swiss chemist, was the first person to ever extract pure psilocybin from the mushrooms that commonly contain it (Psilocybe mexicana). Sandoz, the company that Hofmann worked for at that time, then began to sell the active compound to clinicians and physicians all across the world, which then used the drug as an aiding substance in psychedelic psychotherapy.

In August 1960, Timothy Leary, a psychology professor from Harvard University, traveled to Mexico to conduct a self-experiment using psilocybin mushrooms. After trying pure, extracted psilocybin he decided to experiment even more with the substance, even administering it to his students. In conducting his experiment, he was assisted by his colleague, prof. Dr. Richard Alpert. One of their experiments consisted of administering psilocybin to prisoners, attempting to find out whether it could help reduce recidivism rate and constitute an effective psychotherapy aid. In fact, the results showed a recidivism rate that was 40% lower than expected. In another experiment, Leary and Alpert gave psilocybin to divinity graduate students with the aims of observing the effects of the drug on spiritually predisposed subjects. Students confirmed afterwards that their experience had made positive, lasting changes in their lives.

In 1963, however Dr. Leary and Dr. Alpert were faced with disapproval from other colleagues at Harvard University, eventually leading to their suspension from their jobs at the University. Academics criticized their experiments and their project, describing it as irresponsible and dangerous.[13]

Around the years 1960-1977, psilocybin was first studied as a psychotherapeutic drug. Research on humans in this field was approved by the United States Food and Drug Administration (FDA), but after a while it was ended and did not continue until the late 1990s, when research on the medical use of psilocybin began again.

In 2018 the United States Food and Drug Administration (FDA) granted breakthrough therapy designation for psilocybin-assisted therapy for treatment-resistant major depressive disorder.[14] In 2019, the FDA also granted breakthrough therapy designation for psilocybin therapy treating major depressive disorder more generally.[15]

Medical use

As of 2006, psilocybin is classified as having no accepted medical use in the United States.[12]

In Germany, psilocybin therapy is not illegal per se but the usage of psilocybin during therapy is unlawful. Furthermore, the German Medical Association gave an explicit warning in 2010 about the application of drugs as part of therapy after two patients died during a poly-drug therapy session that year. The drugs used, although including psilocybin and LSD which are known to be reasonably safe, also included more dangerous drugs such as MDMA, heroin and amphetamine.[16]

Since 2014 the Swiss authorities give permission for the usage of psilocybin in some individual cases.[17]

Use for research

Despite psilocybin's illegality in most of the world, psilocybin advocates argue that it is very important to have research on its positive consequences for people with mental illnesses. Thus, there is a bureaucracy to follow for obtaining permission to study psilocybin as used by researchers.[18][19]

In the United States it is only possible to receive psilocybin therapy in context of a study to the effects of this therapy form on different psychological illnesses. The same is true for the United Kingdom and the Netherlands. All three countries are pioneers in studying psilocybin therapy. In 2006 for example people with obsessive-compulsive disorder (OCD) were able to apply for a study at the University of Arizona which observed the effects of psilocybin therapy on OCD.[2]

Another reason was formulated by the president of the German Medical Association in 2010 appealing to official psychotherapies as aiming to support a patient's self-organization instead of a drug-based therapy.[16] On the other hand, there is increasing evidence for the medical practicality of psilocybin. Also, different studies showed that it is not likely that psilocybin induces dependence and the therapeutic index for psilocybin is about 1000, contrasting, for example 10 in alcohol.[20]

References

  1. Nichols, David E. (2020). "Psilocybin: from ancient magic to modern medicine". The Journal of Antibiotics. 73: 679–686. doi:10.1038/s41429-020-0311-8. PMID 32398764.
  2. Moreno, Francisco A.; Wiegand, Christopher B.; Taitano, E. Keolani; Delgado, Pedro L. (2006). "Safety, Tolerability, and Efficacy of Psilocybin in 9 Patients With Obsessive-Compulsive Disorder" (PDF). The Journal of Clinical Psychiatry. 67 (11): 1735–1740. Retrieved 29 November 2020.
  3. Grob, Charles S.; Danforth, Alicia L.; Chopra, Gurpreet S.; Hagerty, Marycie; McKay, Charles R.; Halberstadt, Adam L.; Greer, George R. (2011). "Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer". JAMA Psychiatry. 61 (1): 71–78. doi:10.1001/archgenpsychiatry.2010.116.
  4. Griffiths, Roland R.; Johnson, Matthew W.; Carducci, Michael A.; Umbricht, Annie; Richards, William A.; Richards, Brian D.; Cosimano, Mary P.; Klinedinst, Margaret A. (2016). "Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial". Journal of Psychopharmacology. 30 (12): 1181–1197. doi:10.1177/0269881116675513. PMC 5367557. PMID 27909165.
  5. Ross, Stephen; Bossis, Anthony; Guss, Jeffrey; Agin-Liebes, Gabrielle; Malone, Tara; Cohen, Barry; Mennenga, Sarah E.; Belser, Alexander; Kalliontzi, Krystallia; Babb, James; Su, Zhe; Corby, Patricia; Schmidt, Brian L. (2016). "Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial". Journal of Psychopharmacology. 30 (12): 1165–1180. doi:10.1177/0269881116675512.
  6. Johnson, Matthew W.; Garcia-Romeu, Albert; Cosimano, Mary P.; Griffiths, Roland R. (2014). "Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction". Journal of Psychopharmacology. 28 (11): 983–992. doi:10.1177/0269881114548296. PMC 4286320.
  7. Bogenschutz, Michael P.; Forcehimes, Alyssa A.; Pommy, Jessica A.; Wilcox, Claire E.; Barbosa, P. C. R.; Strassman, Rick J. (2015). "Psilocybin-assisted treatment for alcohol dependence: A proof-of-concept study". Journal of Psychopharmacology. 1: 11. doi:10.1177/0269881114565144.
  8. Kyzar, Evan J.; Nichols, Charles D.; Gainetdinov, Raul R.; Nichols, David E.; Kalueff, Allan V. (2017-11-01). "Psychedelic Drugs in Biomedicine". Trends in Pharmacological Sciences. 38 (11): 992–1005. doi:10.1016/j.tips.2017.08.003. ISSN 0165-6147. PMID 28947075.
  9. Vollenweider, Franz X. (18 August 2010). "The neurobiology of psychedelic drugs: implications for the treatment of mood disorders". Nature Reviews Neuroscience. 11 (9): 642–651. doi:10.1038/nrn2884. PMID 20717121. S2CID 16588263.
  10. Tupper, Kenneth W.; Wood, Evan; Yensen, Richard; Johnson, Matthew W. (2015-10-06). "Psychedelic medicine: a re-emerging therapeutic paradigm". CMAJ : Canadian Medical Association Journal. 187 (14): 1054–1059. doi:10.1503/cmaj.141124. ISSN 0820-3946. PMC 4592297. PMID 26350908.
  11. S., Bordens, Kenneth (2017-03-20). Research design and methods: a process approach. Abbott, Bruce B. (Tenth ed.). Dubuque, IA. ISBN 9781259844744. OCLC 953984959.
  12. Anderson, Brian. "Psychedelic Psychotherapy The Ethics of Medicine for the Soul" (PDF). Penn Bioethics Journal. 2: 9–12.
  13. "When Did Psilocybin Mushrooms First Appear In Human Culture?". The Third Wave. 2016-07-27. Retrieved 2018-05-15.
  14. "COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression – COMPASS". compasspathways.com. Retrieved 2018-12-03.
  15. "FDA grants Breakthrough Therapy Designation to Usona Institute's psilocybin program for major depressive disorder". www.businesswire.com. 2019-11-22. Retrieved 2019-11-25.
  16. http://www.berliner-aerzte.net/pdf/bae0911_012.pdf
  17. "Psycholytische Therapie – petergasser.ch". www.petergasser.ch (in German). Retrieved 2018-05-15.
  18. "Psychedelic Therapy to Improve Mental Health". 2015-09-09. Retrieved 2018-05-15.
  19. Southey, Flora (3 October 2017). "Mind-altering medicine: psilocybin therapy to combat depression". Outsourcing-Pharma.com. Retrieved 1 January 2021.
  20. Rucker, James J. H. (2015). "Psychedelic drugs should be legally reclassified so that researchers can investigate their therapeutic potential". British Medical Journal. 350. doi:10.1136/bmj.h2902.
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