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      Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism

      review-article
      1 , 2 , 3 , 4 , , 2 , 4
      Neuropsychopharmacology
      Springer International Publishing
      Neuroscience, Psychology

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          Abstract

          The clinical investigation of psychedelic medicines has blossomed over the last 5 years. Data from a Phase 3 industry trial and a multicenter Phase 2 industry trial, in addition to multiple early phase investigator-initiated and industry trials, have now been published in peer-reviewed journals. This narrative review summarizes both the recent data and the current clinical trials that are being conducted with various classes of “psyche-manifesting” substances, which may prove beneficial in the treatment of a broad range of conditions. Methodological considerations, unique challenges, and next steps for research are discussed in keeping with the uniquely “experiential” nature of these therapies.

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          Most cited references88

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          Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study

          Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression.
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            Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction.

            Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow-up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20 mg/70 kg) and high (30 mg/70 kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction.
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              Human hallucinogen research: guidelines for safety.

              There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action ('bad trip'), which could lead to potentially dangerous behaviour such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow-up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science.
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                Author and article information

                Contributors
                jennifer.mitchell@ucsf.edu
                Journal
                Neuropsychopharmacology
                Neuropsychopharmacology
                Neuropsychopharmacology
                Springer International Publishing (Cham )
                0893-133X
                1740-634X
                21 July 2023
                21 July 2023
                January 2024
                : 49
                : 1
                : 96-103
                Affiliations
                [1 ]Department of Neurology, University of California San Francisco, ( https://ror.org/043mz5j54) San Francisco, CA USA
                [2 ]Department of Psychiatry and Behavioral Sciences, University of California San Francisco, ( https://ror.org/043mz5j54) San Francisco, CA USA
                [3 ]Department of Veterans Affairs, Research Service, San Francisco VA Medical Center, ( https://ror.org/049peqw80) San Francisco, CA USA
                [4 ]Berkeley Center for the Science of Psychedelics, University of California Berkeley, ( https://ror.org/01an7q238) Berkeley, CA USA
                Author information
                http://orcid.org/0000-0002-7567-8129
                Article
                1656
                10.1038/s41386-023-01656-7
                10700471
                37479859
                a29c5007-3839-423f-a02e-d88ef8761662
                © This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 17 April 2023
                : 5 June 2023
                : 6 July 2023
                Categories
                Review Article
                Custom metadata
                © American College of Neuropsychopharmacology 2024

                Pharmacology & Pharmaceutical medicine
                neuroscience,psychology
                Pharmacology & Pharmaceutical medicine
                neuroscience, psychology

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